invader® mthfr 1298 510(k) summary · the invader® mthfr 1298 software, in combination with...

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Invader® MTHFR 1298 510(k) SUMMARY

A. 510(k) Number:K100496 APR 2 5 2Q011

B. Purpose for Submission:New Device

C. Measurand:mTHFR 1298

D. Type of Test:Qualitative genotyping test for single nucleotide polymorphism detection.

E. Applicant:1lologic Inc.Third Wave Technologies250 Campus DriveMarlborough, MA 0 1752508-263-8912Contact Person: Randall J. Covill, Manager, Regulatory AffairsDate of Submission: April 2010

F. Proprietary and Established Names:Invader MTH-FR 1298

G. Regulatory Information:I . Regulation Sections: 21 CFR 864.72802. Classification:

Class 113. Product Code:

NPR: Test, MTHFR A1I298C Mutations, Genomic DNA PCR4. Panel:

Hematology (81)H. Intended Use:

I. Intended Use(s):The Invader® MTIHFR 1298 test is an in vitro diagnostic test intended for thedetection and genotyping of a single point mutation (A to C at position 1298) of

the human 5,I0-methylenetetrahydrofo late reductase (MTIHFR) gene in isolatedgenomic DNA obtained from whole blood potassium EDTA samples frompatients with suspected thrombophilia.

2. Indication(s) for use:Same as Intended Use

3. Special Conditions for use statemients(s):For prescription use only

4. Special instrument requirements:None

1.Device Description:The Invader N4THFR 1298 test consists of the following components:

MTHFR 1298 Oligo MixUniversal BufferUniversal Enzyme MixNo DNA ControlMTH-FR 1298 Wild Type ControlMTHFR 1298 Heterozygous ControlMTHFR 1298 Mutant ControlInvader Call Reporter m SoftwareInvader® MTHFI( 1298 Software

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J. Substantial Equivalence Information:I1. Predicate device name(s):

Verigene' MTHFR Nucleic Acid Test (Nanosphere, K070597)2. Predicate 5 10O(k) number(s):

Nanosphere, K0705973. Comparison with predicate:

Product Name Verigene' MTHFR Nucleic Acid Invader' MTHFR 1298(Manufacturer, .Test (Hologic, Inc., K]00496)

Submission) (Nanosphere, K070597)

Intended Use "The Verigene MTI-FR Nucleic The Invader® MTI-IFR 1298 test isAcid Test is an in vitro diagnostic an in vitro diagnostic test intendedfor the detection and genotyping of for the detection and genotyping of aa single point mutation (C to T at single point mutation (A to C atposition 677) of the humanS5, 10 position 1298) of the human 5, 10-methylene-tetrahydrofolate methy lenetetrahyd rofol ate reductasereductase gene (MTHFR) in (MTHFR) gene in isolated genornicpatients with suspected DNA obtained from whole bloodthrombophilia, from isolated potassium EDTA samples fromgenomic DNA obtained from patients with suspectedwhole blood samples. The test is thrombophilia.intended to be used on theVerigene System."

The Verigene System is a bench-

top molecular diagnosticworkstation that automates the invitro diagnostic analysis anddetection of nucleic acids using

gold nanoparticle probetechnology. The Verigene Systemis intended to be used byexperienced laboratoryprofessionals with training on basiclaboratory techniques and on the

use of the system components.

Specimen Type Purified DNA isolated from human Same as predicatewhole peripheral blood

Indications for Same as Intended Use Same as Intended Use

Use

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Target Patients with suspected Same as predicate

Population thrombophilia

Chemistry SNP discrimination via. PCR and Invader® usingoligonucleoptide probes; detection Fluorescence Resonance Energyvia evanescent wave light scatter Transfer (FRET) chemistry for signalwith nanoparticles. reporting. Same as predicate device.

Both our device and predicate devicedetect signal from amplicons usingFluorescence Resonance EnergyTransfer (F RET).

Hardware The Verigene System consists of Non-specified, third-patytwo instruments, the Verigene fluorometer and thermal cycler.Processor and the Verigene Reader,and utilizes single-use, disposableTest Cartridges to process andgenotype multiple genes in a DNAsamples in approximately 1.5hours.

Software Embedded software in closed Java-based software installed on aInterface system, integrated graphical user standalone PC capable of converting

interface, raw fluorescence data into genotypecalls.

Detection Method Single-image sensor where PCR and Fluorescence Resonancenanoparticles are illuminated using Energy Transfer (FRET) chemistrya fixed-wave length light source, for signal reporting. Same as

predicate device. Both our device andpredicate device detect signal fromamplicons using FluorescenceResonance Energy Traiisfer (FRET).

Sample Size 25pL 2O0il reaction containing O.25-4ng/ulgONA extracted from humanperipheral whole blood.

IDetection Single-image sensor where Multi-well fluoroineter to detect rawProcedure nanoparticles are illuminated using fluorescence.

a fixed-wavelength light source.

Detection SNP discrimination via PCR and Invader® usingChemistry oligonucleoptide probes; detection Fluorescence Resonance Energy

via evanescent wave light scatter Transfer (FRET) chemistry for signalreporting. Both our device and

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with nanoparticles. predicate device detect signal fromamplicons using FluorescenceResonance Energy Transfer (FRET).

Analysis Time 90 min. processing with 2 min. -90 min. amplification followed by Ianalysis time. min signal detection, Software

analysis post signal detection.

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K. Standard/Guidance Document Referenced (if applicable):

* Guidance for Industry and FDA Staff - Class 11 Special Controls GuidanceDocument: Factor V Leiden DNA Mutation Detection Systems issued onMarch 16, 2004

* Guidance for Industry and FDA Staff - Guidance for the Content ofPremarket Submissions for Software Contained in Medical Devices issuedMay 11, 2005

* Guidance for Industry and FDA Staff - Format for Traditional andAbbreviated 5 10(k)s issued on August 12, 2005

L. Test Principle:

The Invader® MTHFR 1298 test utilizes the Invader Plus" chemistry with DNA isolatedfrom human whole blood, for the detection of the targeted sequence polymorphism.

Specifically, the Invader Plus® chemistry utilizes a single-tube, two phase reaction,including target amplification and signal generation (mediated by Invader® chemistry).Invader Plus® reaction mixes are assembled by combining the MTI-FR 1298 Oligo Mix,Universal Enzyme Mix, and Universal Buffer. In a 96-well plate, reaction mix is combinedwith purified genomic DNA samples, as well as four (4) controls included with the test.The No DNA Control is used by the interpretive software to set the 'noise' component ofthe run for 'signal-to-noise' calculations. The genotype-specific controls (WT, HET, MUT)ensure reagents were assembled correctly and perform according to the specifications. The96-well plate is transferred td an appropriately programmed thermal cycler for targetamplification and signal generation. In the target amplification phase of the reaction,amplification is carried out using 'two-step" cycling conditions (i.e. denaturation &anneal ing/extension). Following amplification, Taq polymerase is inactivated by a 10minute incubation at 990C, after which the thermal cycler proceeds to 630C to initiate thesignal generation (Invadero) phase of the reaction (see Figure I)

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I a. Structure Formiation: 2a. Structure Formration:Wildttype Specific Primary Probe Mutation Specific Primary Probe

lb. Structure Recognition 2b. Structure Recognitionand Cleavage: and Cleavage:

It. Secondary Reaction. 2c. Secondary Reaction:

FRET Cassette (FAM) - FRET Cassette (RED)

Ui0 0 FLUORESCENCE 2: RED

Figure 1. lnvader~ll Signal Generation Phase

During the signal generation phase, a discriminatory Primary Probe transiently hybridizesto the amplified target sequence along with an Invaderd' oligonucleotide, to form anoverlapping structure. The 5'-end of the Primary Probe includes a 5'-flap that does nothybridize to the target DNA. The 3-nucleotide of the bound Invader® oligonucleotideoverlaps the Primary Probe, and does not hybridize to the target DNA. The Cleavase®

enzyme recognizes this overlapping structure and cleaves off the unpaired 5'-flap of thePrimary Probe, releasing it as a target-specific product. The Primary Probe is designed tohave a melting temperature aligned with the Invader® reaction temperature so that under theisothermal reaction conditions (-630C) the Primary Probes cycle on and off the targetDNA. This allows for multiple rounds of Primary Probe cleavage for each DNA targetresulting in an accumulation of the number of released 5'-flaps. The released 5'-flaptransiently hybridizes with a corresponding FRET cassette forming an overlappingstructure that is recognized and the fluorophore is cleaved from the FRET cassette by theCleavase® enzyme. The 5'-flap is designed to have a melting temperature aligned with theInvader®l reaction temperature, so that the 5'-flaps cycle on and off of the correspondingFRET cassettes. This allows for multiple rounds of FRET cassette cleavage for each 5'-flap, and an accumulation of released fluorophore. When the FRET cassette is cleaved, afluorophore and quencher are separated, generating detectable fluorescence signal. Theformat uses two different discriminatory Primary Probes, one for the mutant allele and onefor the wild type allele (Figure 1). Each Primary Probe is assigned a unique 5'-flap, anddistinct FRET cassette, with a spectrally distinct fluorophore. By design, the released 5'-flaps will bind only to their respective FRET cassettes to generate a target-specific signal,linking the wild type allele with one fluorophore (Fluorescence 1: FAM) and the mutantallele with the second fluorophore (Fluorescence 2: RED).

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The Invader® MTHFR 1298 software, in combination with Invader Call Reporter m

software, is a data analysis software package developed by Hologic for use with thleInvader® MTHFR 1298 test. The software package provides a working template for thlesetup of reaction mixes and sample placement, and following the import of fluorescencedata, it determines results and validity for controls and samplesA summary of the InvaderCall Reporter m- Invader® MTHIW 1298 package workflow is shown in Figure 2.

Assay Selection'1. Enter Operator and Run ID2, Select MTHFR 12983. Enter Number of Samples

3. Reaction Mix amounts are calculated

.ImotfurScene dlaceta

fluororne1. En.e Printe Reslt PI sredhe4. SvREsut a pl D omandnCs

5ExtResults t pedhe n S

Save Sumaroa

Figur 2.t Invde C all r Repo ts nd er MTItaF f298 Packages Wornd

file ~ ~ ~ ~ ~ ~ ~ ~ ~ Pg 7ro ofmle 13 i~aodfrvld ltsv

M. Performance Characteristics (if/when applicable):1. Analytical performance:

a. Precision/Reproducibility:External Reproducibility (Study fl): Two operators each from three (3) differentsites (2 external sites and I internal site) performed the testing, in duplicate, overfive (5) non-consecutive days for a ten (10) day period using the same testingmaterials including a panel of nine (9) whole blood samples specific for each ofthe three (3) possible, genotypes (i.e. wild type, heterozygous, homozygousmutant).

Sieteao aes Correct No Calls cret No Calls AgreementCalls (Invalid, Miscalls Correct ald, Mical

Site 1 90 90 0 0 90 0 0 100%001 2 90 90 0 0 go 0 0 100%Site 1 g0 90 0 0 90 0 0 100%002 2 90 90 0a 0 90 0 a 100%site 1 90 90 0 0 90 0 0 100%003 2 90 90 0 0 90 0 0 100O%All Atl 540 540 - 0 0 540 0 0 100%

Lot-to-Lot Reproducibility (Study #9): A total of nine (9) genornic DNA samples(three (3) wild type , three (3) heterozygous and three (3) mutants) were tested inquadruplicate using three (3) different kit lots of the Invader®) MTHFIR 1298 test.The percent agreement between Invader® MTHFR 1298 test and sequencing was100% (n=108).

-al -: Lo to Lo -erdui-ltF irst First Final Final

Lot Samples Pass Pass No Miscalls Correct AgreementTested Correct CallsCal%

S~CallsCal

1 36 36 0 0 36 1002 36 36 0 0 36 1003 36 1 36 0 0 36 100

Total 108 108 0 0 108 100

b. Linearity/assay reportable range:Refer to paragraph D below.

c. Traceability, Stability, Expected values (controls, calibrators, or mlethod,):Real-Time Stability Study (Study #5): Three (3) lots of product in the finalconfiguration are being stored under recommended conditions: (I1) -30* to -1I50C(Standard Storage of intermediate components) as well as (2) +20 to +80C(Standard Storage of Genotype-Specific Controls). Functional testing isperformed with samples representing all 3 genotypes in quadruplicate at eachtime point. The interim test results have demonstrated 7 months stability for thedevice.

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Seq uencing/Samiple/ ExpectedControl NITHZFR 1298 T, Result T4 Result T, Result

Genotype

Lot I Lot 2 Lot 3 ['ot I Lot 2 Lot 3 Lot I Lot 2 Lot 3

Control I WI WT WI' WIT WIT WT' WT w'r WT WT

Control 2 HET HET I-lE WET HET HET H ET ilET 111 3 1' 1 WE ET

Control 3 MUT M UT MIJT MUT MUT MUT MUT MUlT MUT MLJT

gDNA I WT W'T WT WT WT WT WT W'T WI' WIT

gI)NA 2 WI WT WT WT WT WT WT wTr WT WVF

gDNA 3 HET WET 111ET [lET HET IlET HE]' WET HET WET

gONA 4 MUll MU]' MUl' MUT MUT MUll MU'I M UT MUT MUT

Percent Agreement 100 100 100 100 100 100 100 100 100

Reagent Freeze-Thaw Stability Study (Study #6): Product in the finalconfiguration was subject to 15 freeze-thaw cycles prior to the final thaw at thetime of testing. Functional testing was performed using genomnic DNA isolatedfrom cell lines, representing all possible genotypes. The percent agreementbetween the sequencing result and the Invader® MTHFR 1298 test were 100%,therefore demonstrating stability for up to fifteen (I15) freeze/thaw cycles.

Tabl 5: FreeTa.tblt4o nae TFR19

Numnbcr of F4rcczc/TMawvCyclesSample I 2 3 4 5 6 7 8 9 10 11 12 13 14 I5 Total % AgreementCont)roll 1 3 3 3 3 3 3 3 3 3 3 3 3 3 3 45 100

Conto2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 45 100

Cotrl , 3 3 3 3 3 3 3 3 3 3 3 3 3 3 45 100

(MT)

gOA 8 * 8 8 * * 8 8 8 48 100(HET)gONAT 6 * 6 * 6 * * * 6 * 6 * * 6 36 100

Total 12919129 9 29 9 9 9 929 I9I29 9 9 29 25 5 too'*Testing wvith gONA samples did not occur at this testingpit

d. Detection limit/A na/vt/cal Sensitivity and Normal Range (Study #3):Three (3) genomic DNA samples with different genotypes (i.e. WT, H'ET, MUT)were extracted from whole blood collected in potassium EDTA. Each samplewas diluted to eight different concentrations 0.5, 5, 20, 40, 80, 200, 400O, 800 ng/pL and tested in replicates of forty (40). The recommend range of the assay was

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determined to be between 5-80 ng/pL of input gDNA, based on 100%

concordance of all tested replicates with bi-directional sequencing.

Table 6: Percent Agreement Between Replicates

20 ng/ample0I (0/40) p ba00% (4040 S00%u(40/40)

40pu Sample 070 (0/4) 00%2 (0/4) 00%3 (0/4)

80cetringp I00 (4/0 I0%(04)10 4/0

2005 ng/V1l 100% (40/40) 1005% (40/40) 100% (40/40)

40 ng/pl 100% (40/40) 100% (40/40) 100% (40/40)

800 ngtl 100% (40/40) 100% (40/40) 100% (40/40)

e. Analytical sycci/ icity ('Interfering Substances) (Study M.)-Test performance was not affected by addition of the following substances tonine (9) whole blood samples of different genotype (3 WI, 3 HIET, 3 MIJT) priorto extraction:

" H-eparin (1500 U/dL human whole blood)* Cholesterol (300 mg/dL human whole blood)* Bilirubin (10 mg/dL human whole blood)" Hemoglobin (up to 0.2% in whole blood)" Potassium EDTA (1.8 mg/mL human whole blood)* Ethanol-based Wash Buffer (5% in DNA sample)

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Table 7: Summary, Comparison of Invader® MTHfFR 1298 Interfering Substance Resultsto Sequencing

Inefrn Susac Cocnrto % Agemn Igreet PS

Susac (i blood ir DNi apeitihFI

code Seqen(Untreated)e

A No Hemoglon .%Cood) 100% (18 of 18) N0%(I/fA 8 PASS

B2 Hemlbin 0.1%d (blood) 100% (18 of 18) 100% (18 of 18) PASS

P3I Hemoglobin 0.05% (blood) 100% (18 of 18) 100% (18 of 18) PASS

F2 Hemoglobin 0.25% (blood) 100% (18 of 18) 100% (18 of 18) PASS

G Buffer AW2 5% (DNA) 100% (18 ofl18) 100% (18 of IS) PASS

f Pre-A nalytical Equivalency Study/Genoinic DNA Extraction Reproducibility(Study 47): Thirty (30) human whole blood samples and ten (10) leukocytedepleted whole blood spiked with cell lines were divided and extracted using four(4), commercially available DNA extraction methods (A. Qiagen QlAamp® 96DNA Blood Kit, B. Qiagen QlAamp® DNA Blood Mini Kit, C. GentraGenerationo' Capture Column Kit (Qiagen), D. Roche MagNA Pure LC DNAIsolation Kit 1). The 160 extracted DNAs were analyzed in singlicate with one (1)lot of the device. The percent agreement between the Invader® MTHJFR 1298 testfor each extraction method and bi-directional sequencing was 100% (n=40).

-Pagel11ofl13

-al 8: Pr-Aaltia Eqiv-ec# First First Final Final

Extraction Smls Pass -Pass Miscalls Correct AgreementMethod smpes Correct No Calls%

Tesed Calls Calls

A 40 40 0 0 40 100B 40 39 1 * 0 39* 100*C 40 40 0 0 40 100D 40 40 0 0 40 100

Total 160 159 1 0 159 100*Saimple was removed from study due to loss of traceability of the sampleidentification.

g. Instrument Equivalency (Study #8): Twenty-nine (29) human whole bloodsamples and ten (10) leukocyte depleted whole blood samples spiked with celllines were extracted using two (2) commonly used extraction methods. Theextracts were tested with the Invader® MTH-FR 1298 test using three (3)commercially available thermal cyelers (I. ABI GeneAmp® PCR System 9700with 96-well gold block, 2. ABI VeritiTM and 3. MJ Research PTC- 100) and theraw fluorescent data acquired on three (3) commercially available fluorometers(A. Tecan Infinite®, B. Tecan Genios® and C. BioTek®, FLxSOO). Results fromnthe three (3) fluorometers were transferred into the interpretive software andgenotype calls compared to bi-directional sequencing.

-al 9: CocracIyIsrmnThermal Cycler

Fluorometer 1 2 13A 78 of78 =100% 78 of78 =100% I 78 of78 =100%B 78 of 78 =100% 78 of78 =100% 78 of78 =100%C 78 of 78 =100% 78 of78=- 100% 78 of 78= 100%

2. Comparison studies:a. Method comparison: Bi-directional Sequencing (Study #2):

Human whole blood samples (n = 348) underwent DNA extraction andsubsequent hi-directional DNA sequence analysis. The same DNAsamples were then analyzed using the Invader® MTHFR 1298 test. Theobserved agreement between the Invader® MTHFR 1298 test and bi-directional DNA sequencing was 100% (347/347). The first runagreement with bi-directional sequencing was 99.7 1% (347/348).

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Number of Number ofMTHFR Number IValid Correct First Run

128tested Results on genotype AgreementGenotype* 1l'Run calls on

First RunHomozygousWild Type 183 182** 182** 99.45%

(GG)Heterozygous 125 125 125 100%

(GA) ____

HomozygousMutant 40 40 40 100%(AA) _______ _

Total 348 347** 347** 99.71%* Genotype determined through bi-directional DNA sequencing

**One sample failed to generate valid results. This sample was reportedas invalid (EQ) and no genotype call was assigned by the interpretive

software. The EQ result was used to determine the First Rujn Agreement.

3. External Reproducibility studies:a. Clinical Sensitivity: please refer to section I d above.b. Clinical specificity please refer to section Ile above.

4. Expected values/Reference range: (Prevalence)MTHFR A I298C: --33%

N. System Descriptions:I. Modes of Operation:

Closed System2. Software:

FDA has reviewed applicant's Hazard Analysis and software developmentprocesses for this line of product type. Yes X_ or No_____

3. Specimen Identification:Manual Labeling

4. Specimen Sampling and Handling:DNA should be extracted using a validated DNA extraction method thatgenerates DNA concentration range of greater than Sng/pl.

5. Quality Control:Each test contains positive and negative controls to assure proper functioning ofthe system: Failure of any controls will be indicated as "Invalid" in the testresults section of the report. The genotyping test result will not be reported forany sample for which a positive or negative control failure occurs.Positive Control: The genotype controls (WT, HET, MUT) ensure reagents wereassembled correctly and perform according to the specifications.Negative Control: The No DNA Control is used by the interpretive software toset the "noise" component of the run for "signal-to-noise" calculations.Hardware and Software Controls:

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The genotyping test result will not be reported for any sample for which apositive or negative control failure occurs.

0. Proposed Labeling:The labeling is sufficient and. satisfies the requirements of 2l CFR Part 809.10.

P. Conclusion:The submitted information in this 510 (k) notification is complete and supports asubstantial equivalence decision.

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DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Food and Drug Administration10903 New Hampshire AvenueSilver Spring, MD 20993

Hologic Inc.Third Wave Technologiesc/o Mr. Randall J. CovillSenior Specialist Regulatory Affairs APR 2 5 2011502 South Rosa RoadMadison, WI 53719

Re: k100496Trade/Device Name: Invader® MTHFR 1298Regulation Number: 21 CER §864.7280Regulation Name: Factor V Leiden DNA Mutation Detection SystemsRegulatory, Class: Class 11Product Code: 0MMDated: March 31, 2011Received : April 7, 2011

Dear Mr. Covill:

We have reviewed your Section 5 10(k) premarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for the indicationsfor use stated in the enclosure) to legally marketed predicate devices marketed in interstatecommerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or todevices that have been reclassified in accordance with the provisions of the Federal Food, Drug,and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).You may, therefore, market the device, subject to the general controls provisions of the Act. Thegeneral controls provisions of the Aci include requirements for annual registration, listing ofdevices, good manufacturing practice, labeling, and prohibitions against misbranding andadulteration.

If your device is classified (see above) into class 11 (Special Controls), it may be subject to suchadditional controls. Existing major regulations affecting your device can be found in Title 21,Code of Federal Regulations (CFR), Parts 800 to 895. in addition, FDA may publish furtherannouncements concerning your device in the Federal Registcr.

Please be advised that FDA's issuance of a substantial equivalence determination does not meanthat FDA has made a determination that your device complies with other requirements oCf the Actor any Federal statutes and regulations administered by other Federal agencies. You mustcomply with all the Act's requirements, including, but not limited to: registration and listing (21

CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting ofmedical device-related adverse events) (21 CFR 803); and good manufacturing practicerequirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter

Mr. Randall J. Covill

will allow you to begin marketing your device as described in your Section 5 10(k) preniarketnotification. The FDA finding of substantial equivalence of your device to a legally marketedpredicate device results in a classification for your device and thus, permits your device toproceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarketnotification" (21 CFR Part 807.97). For questions regarding the reporting of adverse eventsunder the MDR regulation (21 CFR Part 803 ), please go tolhttp://www.fda.gov/Medicai]Devices/Safetv/ReportaProblemi/default.htmy for the CDRH-'s Officeof Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from thleDivision of Small Manufacturers, International and Consumer Assistance at its toll-free number(800) 638-2041 or (301) 796-7100 or at its Internet addresslhttp://www.fda. ,,ov/cdi-I/inidustry/suppor-t/index.htnml.

Sincerely yours,

AdMaria M. Chan, Ph.DDirectorDivision of Immunology and Hematology DevicesOffice of In Vitro Diagnostic Device Evaluation and SafetyCenter for Devices and Radiological Health

Enclosure

Indication for Use Statement

5 10(k) Number (if known): k100496.

Device Name: Invader MTHFR 1298 test

Indication for Use:

The Invader® MTHFR 1298 test is an in vitro diagnostic test intended for the detectionand genotyping of a single point mutation (A to C at position 1298) of the human 5,10-methyl enetetrahydrofol ate reductase (MTHFR) gene in isolated genomic DNA obtainedfrom whole blood potassium EDTA samples from patients with suspected thrombophilia.

Prescription Use _X AND/OR Over-The-Counter Use ____

(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Divsion Sign-Off

Office of In Vitro DiagnosticDevice Evaluation and Safety

510(k) /coel?&

invader® mthfr 1298 510(k) summary · the invader® mthfr 1298 software, in combination with...

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