fda-cleared/approved molecular - harrison...

FDA-CLEARED/APPROVED MOLECULAR DIAGNOSTICS TESTS

This table is current through Nov 10, 2010

The following table is a listing of the in vitro molecular diagnostic products that are cleared or approved for diagnostic use in the United States by the Food and Drug Administration. Such tests are classified as "Medical Devices." More information is available at the website for FDA’s Office of In Vitro Diagnostic (OIVD) Evaluation and Safety: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/default.htm. This list is for informational purposes only and is not intended as an endorsement or recommendation in any way of the products and manufacturers listed by the Association for Molecular Pathology or any of its officers or members. Companies are listed alphabetically within each category. Every effort is made to keep this list error-free and current. Please email comments, corrections, additions, etc. to Carol A. Holland, Ph.D. ([email protected]).

ABBREVIATIONS: 510(k): Premarket Notification PCR: Polymerase Chain Reaction ASPE: Allele Specific Primer Extension PMA: Premarket Approval bDNA: Branched Chain DNA Signal Amplification PNA: Peptide Nucleic Acid BLA: Biological License Application QC: Quality control DKA: Dual Kinetic Assay RT-PCR: Reverse-Transcription PCR ELISA: Enzyme-linked Immunosorbent Assay SDA: Strand Displacement Amplification FISH: Fluorescent in situ Hybridization TC: Target Capture HPA: Hybridization Protection Assay TMA: Transcription Mediated Amplification NASBA: Nucleic Acid Sequence Based Amplification

INFECTIOUS DISEASE TESTS - BACTERIAL and FUNGAL

TEST

MANUFACTURER

TEST NAME

METHOD REGULATORY

ROUTE FOR PREMARKET

REVIEW Bacillus anthracis Idaho Technology, Inc.

Salt Lake City, UT Joint Biological Agent Identification and Diagnostic System (JBAIDS) Anthrax Detection kit

Real-time PCR 510(k)

AdvanDx Woburn, MA

C. albicans PNA FISH PNA FISH 510(k) Candida albicans and Candida spp.

AdvanDx Woburn, MA

Yeast Traffic Light PNA FISH™1 PNA FISH 510(k)

BD Diagnostics - GeneOhm San Diego, CA

GeneOhm Cdiff Assay Real-time PCR 510(k)

Cepheid Sunnyvale, CA

Xpert™ C. difficile Test (also see under Systems below: GeneXpert™ Real-time PCR System )


Meridian Bioscience Cincinnati, OH

Illumigene™ C. difficile Loop amplification technology

510(k)

Clostridium difficile

Gen-Probe, Inc. (Prodesse) San Diego, CA

ProGastro™ Cd Assay Multiplex Real-time PCR

510(k)

BD Diagnostic Systems Sparks, MD

BD ProbeTec™ Chlamydia trachomatis (CT) Qx Amplified DNA Assay

SDA 510(k)

Gen-Probe, Inc. San Diego, CA

APTIMA CT® Assay TC, TMA, DKA

510(k)

Chlamydia trachomatis detection (single organism)


PACE® 2 CT Probe Competition Assay (Ct-confirmation test)

HPA 510(k)

Qiagen, Inc. Germantown, MD

HC2® CT ID Hybrid Capture 510(k)

Roche Molecular Diagnostics Pleasanton, CA

AMPLICOR® CT/NG Test for Chlamydia trachomatis

PCR 510(k)


COBAS® AMPLICOR® CT/NG Test for Chlamydia trachomatis2

PCR 510(k)

BD Diagnostic Systems Sparks, MD

BD ProbeTec™ Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay

SDA 510(k)


APTIMA® GC Assay TC, TMA, DKA

510(k)


PACE® 2 GC Probe Competition Assay (GC-confirmation test)

HPA 510(k)


HC2® GC ID Hybrid Capture 510(k)


AMPLICOR® CT/NG Test for Neisseria gonorrhoeae

PCR 510(k)

Neisseria gonorrhoeae detection (single organism)


COBAS AMPLICOR® CT/NG Test for Neisseria gonorrhoeae1

PCR 510(k)

Abbott Molecular, Inc. Des Plaines, IL

Abbott® Real-time CT/NG (also see under Systems below: Abbott m2000™ [m2000sp + m2000rt])



BD ProbeTec™ ET C. trachomatis and N. gonorrhoeae amplified DNA Assay (also see under Systems below: BD Viper™ System)

SDA 510(k)


APTIMA Combo 2® Assay (also see under Systems below: TIGRIS® DTS™ System)

TC, TMA, DKA

510(k)


PACE® 2C CT/GC HPA 510(k)

Chlamydia trachomatis and Neisseria gonorrhoeae detection


HC2® CT/GC Combo Test Hybrid Capture 510(k)


AMPLICOR® CT/NG Test PCR 510(k)


COBAS AMPLICOR™ CT/NG Test1

PCR 510(k)

Enterococcus faecalis AdvanDx Woburn, MA

Enterococcus faecalis PNA FISH® PNA FISH 510(k)

Escherichia coli and Pseudomonas aeruginosa

AdvanDx Woburn, MA

E. coli/P. aeruginosa PNA FISH® PNA FISH 510(k)

Escherichia. coli, Klebsiella pneumoniae and Pseudomonas aeruginosa

AdvanDx Woburn, MA

EK/P. aeruginosa PNA FISH® PNA FISH 510(k)

Francisella tularensis Idaho Technology, Inc. Salt Lake City, UT

Joint Biological Agent Identification and Diagnostic System (JBAIDS) Tularemia Detection kit


Gardnerella, Trichomonas vaginalis and Candida spp. Detection


BD Affirm™ VPIII Microbial Identification Test

Hybridization 510(k)

Group A Streptococci detection


Group A Strep direct (GASD) HPA 510(k)

AdvanDx Woburn, MA

GBS PNA FISH® PNA FISH 510(k)


IDI-Strep B™ Assay Real-time PCR 510(k)


BD Max™ GBS Assay Real-time PCR 510(k)


Smart GBS (also see under Systems below: SmartCycler™ Real-time PCR System )



Xpert™ GBS (also see under Systems below: GeneXpert™ Real-time PCR System )


Group B Streptococci detection


Group B AccuProbe® HPA 510(k)


IDI-MRSA™ Assay Real-time PCR 510(k)


Xpert™ MRSA (also see under Systems below: GeneXpert™ Real-time PCR System )


MRSA for Staphylococcus aureus - Screening assay


LightCycler® MRSA Advanced Test (also see under Systems below: LightCycler® 2.0)


MRSA/SA for Staphylococcus aureus - Screening assay


Xpert™ MRSA/SA Nasal Assay (also see under Systems below: GeneXpert™ Real-time PCR System )



GeneOhm StaphSR Real-time PCR 510(k) MRSA for Staphylococcus aureus -Diagnostic assay for positive blood cultures Cepheid

Sunnyvale, CA Xpert™ MRSA/SA Blood Culture Assay (also see under Systems below: GeneXpert™ Real-time PCR System )


MRSA for Staphylococcus aureus -Diagnostic assay for Skin and Soft Tissue Infection


Xpert(TM) MRSA/SA Skin and Soft Tissue Infection (SSTI) test (also see under Systems below: GeneXpert™ Real-time PCR System )


Mycobacterium tuberculosis detection


AMPLIFIED™ Mycobacterium tuberculosis Direct Test (MTD)

TMA PMA

Mycobacteria spp., different fungi and bacteria culture confirmation


AccuProbe® Culture Identification Tests3

HPA 510(k)

Staphylococcus aureus AdvanDx Woburn, MA

S. aureus PNA FISH PNA FISH 510(k)

Vancomycin resistance Cepheid Sunnyvale, CA

Xpert vanA test (also see under Systems below: GeneXpert™ Real-time PCR System )


1Five Candida species directly from positive blood cultures including: C. albicans and/or C. parapsilosis, C. tropicalis, and C. glabrata and/or C. krusei

2C. trachomatis and N. gonorrhoeae detection may now be done using the Roche COBAS Amplicor system directly from Cytyc Corporation’s ThinPrep Pap test collection kit; this use is FDA Approved.

3Campylobacter spp., Enterococcus spp., Group B Streptococcus, Haemophilus influenzae, Neisseria gonorrhoeae, Streptococcus pneumoniae, Staphylococcus aureus, Listeria monocytogenes, Group A Streptococcus, Mycobacterium avium, Mycobacterium intracellulare, Mycobacterium avium complex, Mycobacterium gordonae, Mycobacterium tuberculosis complex, Mycobacterium kansasii, Blastomyces dermatitidis, Coccidioides immitis, Crytococcus neoformans, Histoplasma capsulatum.

INFECTIOUS DISEASE TESTS - VIRAL TEST MANUFACTURER TEST NAME METHOD REGULATORY

ROUTE FOR PREMARKET

REVIEW Avian Flu Centers for Disease Control

and Prevention Influenza A/H5 Real-time RT-

PCR 510(k)

bioMérieux, Inc. Durham, NC

CMV pp67 mRNA NASBA 510(k)

Gentech Diagnostics Pvt. Ltd. New Delhi, India

Hybrid Capture® CMV DNA Test Hybrid Capture with Chemi-luminescent detection

510(k)

Cytomegalovirus detection


HC1® CMV DNA Test Hybrid Capture 510(k)


NucliSENS EasyQ® Enterovirus (also see under Systems below: NucliSENS EasyQ® System)

Real-time NASBA

510(k) Enterovirus detection


Xpert™ EV (also see under Systems below: GeneXpert™ Real-time PCR System )


HBV Quantification Abbott Molecular, Inc. Des Plaines, IL

Abbott Real-time HCV (also see under Systems below: Abbott m2000™ [m2000sp + m2000rt])

Real-time RT-PCR

PMA


COBAS® TaqMan® HBV Test, for use with the HighPure System

Real-time PCR PMA


COBAS® AmpliPrep / COBAS® TaqMan® HBV Test v2.0

Real-time PCR PMA

Gen-Probe, Inc. San Diego, CA (distributed by Siemens Healthcare Diagnostics, Deerfield, IL)

VERSANT® HCV RNA TMA PMA


AMPLICOR™ HCV Test, v2.0 RT-PCR PMA

HCV Qualitative detection


COBAS® AMPLICOR™ HCV Test, v2.0

RT-PCR PMA

Siemens Healthcare Diagnostics Deerfield, IL

VERSANT® HCV RNA 3.0 Assay (bDNA) (also see under Systems below: VERSANT™ 440 Molecular System)

bDNA PMA


COBAS® AmpliPrep/ COBAS® TaqMan HCV Test (also see under Systems below: COBAS® AmpliPrep/COBAS® TaqMan)

Real-time RT-PCR

PMA

HCV Quantification


COBAS TaqMan HCV v2.0 Real-time RT-PCR

510(k)

Celera Diagnostics Alameda, CA (distributed by Abbott Laboratories, Abbott Park, Il)

ViroSeq™ HIV-1 Genotyping System

Sequencing 510(k)

HIV drug resistance testing


TruGene™ HIV-1 Genotyping and Open Gene DNA Sequencing System

Sequencing 510(k)


Abbott Real-time HIV-1 (also see under Systems below: Abbott m2000™ [m2000sp + m2000rt])

Real-time RT-PCR

PMA


NucliSens®HIV-1 QT NASBA PMA

HIV Quantification


AMPLICOR HIV-1 MONITOR™ Test, v1.5

RT-PCR PMA


COBAS AMPLICOR HIV-1 MONITOR™ Test, v1.5

RT-PCR PMA


COBAS® AmpliPrep/ COBAS® TaqMan HIV-1 Test (also see under Systems below: COBAS® AmpliPrep/COBAS® TaqMan)

Real-time RT-PCR

PMA


COBAS® AmpliPrep/ COBAS® TaqMan HIV-1 Test, v.2.0 (also see under Systems below: COBAS® AmpliPrep/COBAS® TaqMan)

Real-time RT-PCR (dual-target assay)

PMA


VERSANT® HIV-1 RNA 3.0 Assay (bDNA)

bDNA PMA

BioLife Plasma Services, L.P.Deerfield, IL 60015

Hepatitis C Virus (HCV) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assay

RT-PCR BLA

BioLife Plasma Services, L.P.Deerfield, IL 60015

Human Immunodeficiency Virus, Type 1 (HIV-1) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assay

RT-PCR BLA

Gen-Probe, Inc. San Diego, CA (distributed by Chiron)

Procleix® HIV-1/HCV Assay (also see under Systems below: Procleix® Semi-Automated Instrument System)

TC, TMA, HPA

510(k)

Gen-Probe, Inc. San Diego, CA (distributed by Chiron)

Procleix® ULTRIO® Assay (HIV-1, HCV and HBV) (also see under Systems below: Procleix® Semi-Automated Instrument System)

TC, TMA, HPA

510(k)

National Genetics Institute Los Angeles, CA

UltraQual™ HCV RT-PCR Assay RT-PCR BLA

HBV/HCV/HIV for blood , blood component and tissue donations

National Genetics Institute Los Angeles, CA

UltraQual™ HIV-1 RT-PCR Assay RT-PCR BLA

http://www.fda.gov/cber/products/hiv1bio013107.htm





COBAS® AmpliScreen™ HBV Test

PCR BLA


COBAS® AmpliScreen™ HCV Test, v2.0

RT-PCR BLA


COBAS® AmpliScreen™ HIV-1 Test, v1.5

RT-PCR BLA


COBAS® TaqScreen MPX® Multiplex Real-time PCR and RT-PCR

BLA

Herpes Simplex virus 1 and 2 Eragen Biosciences Madison, WI

Multicode - RTX Herpes Simplex Virus 1 and 2 kit, Model 3711

Multicode chemistry PCR and Real-time PCR

510(k)

Human Metapneumovirus Gen-Probe, Inc. (Prodesse) San Diego, CA

Pro hMPV+™ Assay Multiplex Real-time RT-PCR

510(k)

Hologic, Inc. (Third Wave Technologies) Bedford, MA

Cervista™ HPV HR (high risk) Invader® Chemistry

PMA


Cervista™ HPV 16/18 Invader® Chemistry

PMA


HC2® HR and LR Hybrid Capture PMA


HC2®HPV HR Hybrid Capture PMA

Human Papillomavirus Testing


HC2® DNA with Pap Hybrid Capture PMA

Influenza Virus Panel

Centers for Disease Control Atlanta, GA

Human Influenza Virus Real-time RT-PCR Detection and Characterization Panel (also see under Systems below: ABI 7500 Fast Dx Real-Time PCR Instrument)

Real-time RT-PCR

510(k)

Influenza Virus – H1N1 Focus Diagnostics Cypress, CA

Simplexa™ Influenza test Real-time RT-PCR

510(k)

Luminex Molecular Diagnostics Toronto, Canada

xTAG Respiratory Viral Panel1

(also see under Systems below: Luminex LX 100/200)

RT-PCR, ASPE, Tag sorting

de novo 510(k)

Nanosphere, Inc. Northbrook, IL

Verigene® Respiratory Virus Nucleic Acid Test and Verigene®

Respiratory Virus Test-SP (also see under Systems below: Verigene® System)

Multiplex Gold Nanoparticle Probes

510(k)


ProFlu+™ Assay2 Multiplex Real-time RT-PCR

510(k)


ProFast+ assay3

Respiratory virus panel


ProParaFlu+™ Assay2 Multiplex Real-time RT-PCR

510(k)


Procleix® WNV Assay Real-time PCR 510(k) West Nile for blood donations


COBAS® TaqScreen WNV TC, TMA, HPA

510(k)

1Viruses include: three types of Influenza A, a strain of influenza B, adenovirus, respiratory syncytial virus A and B, Metapneumovirus, Parainfluenzas 1, 2, and 3, and rhinovirus. 2Viruses include: influenza A and B viruses and respiratory syncytial virus

3Viruses include: seasonal A/H1, seasonal A/H3, and 2009 H1N1

MOLECULAR DIAGNOSTIC TESTS - HUMAN TEST MANUFACTURER TEST NAME METHOD REGULATORY

ROUTE FOR PREMARKET

REVIEW

B-Cell Chronic Lymphocytic Leukemia (B-CLL)


CEP®12 DNA Probe Kit FISH 510(k)

Bladder Cancer - Initial diagnosis of bladder cancer in patients with hematuria and monitoring tumor recurrence of bladder cancer


UroVysion® (also see under Systems below: BioView Duet Scanning System)

FISH PMA

Agendia, Amsterdam, The Netherlands

MammaPrint Microarray analysis

510(k) Breast Cancer - Determination of the likelihood of metastasis

Veridex, LLC Warren, NJ

GeneSearch™ BLN Test Real-time RT-PCR

PMA

Breast Cancer - Detection of amplifications and deletions of the TOP2A gene

Dako Denmark A/S Glostrup, Denmark DK-2600

TOP2A FISH pharmDx™ Kit FISH on FFPE breast tissue

PMA

Chromosome 8 Enumeration (CML, AML, MPD, MDS)


CEP®8 DNA Probe Kit FISH 510(k)

Celera Diagnostics Alameda, CA

Cystic Fibrosis Genotyping Assay Multiplex PCR, OLA and electrophoresis

510(k)


InPlex™ CF Molecular Test Invader® Chemistry

510(k)


Tag-It™ Mutation Detection Kit CFTR 40+4

PCR, ASPE, Tag sorting

de novo 510(k)


XTag Cystic Fibrosis 39 Kit v2 PCR, ASPE, Tag sorting

510(k)


XTag Cystic Fibrosis 60 Kit v2 PCR, ASPE, Tag sorting

510(k)

Cystic Fibrosis

Nanosphere, Inc. Verigene® CFTR Nucleic Acid Test Multiplex Gold 510(k)

Northbrook, IL and CFTR POLYT Nucleic Acid Test (also see under Systems below: Verigene® System)

Nanoparticle Probes

Osmetech Molecular Diagnostics, Pasadena, CA

eSensor® Cystic Fibrosis Carrier Detection System (also see under Systems below: eSensor® 4800 System)

PCR, Probe Hybridization

510(k)


eSensor® Cystic Fibrosis Genotyping Test on eSensor XT-8 (also see under Systems below: eSensor® XT-8 System)


510(k)

AutoGenomics, Inc. Carlsbad, CA

INFINITI™ 2C9 & VKORC1 Multiplex Assay for Warfarin (also see under Systems below: INFINITI™ Analyzer)

PCR and Detection Primer Extension

510(k)


INFINITI™ CYP2C19 Assay [for Plavix] (also see under Systems below: INFINITI™ Analyzer)


510(k)


Invader® UGT1A1 Molecular Assay

Invader® Chemistry

510(k)


Verigene® Warfarin Metabolism Nucleic Acid Test (also see under Systems below: Verigene® System)


510(k)


eSensor Warfarin Sensitivity Test (also see under Systems below: eSensor® XT-8 System)


510(k)

ParagonDx, LLC Morrisville, NC

Gentris Rapid Genotyping Assay -CYP2C9 & VKORC1


Roche Diagnostics Pleasanton, CA

AmpliChip™ Cytochrome P450 Genotyping Test (also see under Systems below: Affymetrix GCS 3000Dx Instrumentation System)

Microarray 510(k)

Drug metabolizing Enzymes

TrimGen Corp Sparks, MD

eQ-PCR™ LC Warfarin Genotyping Kit



INFINITI™ System Assay for Factor II (also see under Systems below: INFINITI™ Analyzer)


510(k)


Verigene® F2 Nucleic Acid Test (also see under Systems below: Verigene® System)


510(k)

Factor II (prothrombin) (single assay)


Factor II (prothrombin) G20210A kit (also see under Systems below: LightCycler Instrument v. 1.2)



INFINITI™ System Assay for Factor V (also see under Systems below: INFINITI™ Analyzer)


510(k)


Verigene® F5 Nucleic Acid Test (also see under Systems below: Verigene® System)


510(k)

Factor V Leiden (single assay)


Factor V Leiden kit (also see under Systems below: LightCycler Instrument v. 1.2)



INFINITI™ System Assay for Factor II & Factor V (also see under Systems below: INFINITI™ Analyzer)


510(k)


Xpert™ Hemosil Factor II & Factor V Assay (also see under Systems below: GeneXpert™ Real-time PCR System )


Factor II (Prothrombin) and Factor V Leiden (combined assay)


Verigene® F5/F2 Nucleic Acid Test (also see under Systems below: Verigene® System)


510(k)

Factor II (Prothrombin), Factor V Leiden and MTHFR


Verigene® F5/F2/MTHFR Nucleic Acid Test (also see under Systems below: Verigene® System)


510(k)

Heart Transplant Recipients XDx, Inc. AlloMap® Molecular Expression Quantitative 510(k)

- Identification of the potential risk for transplant rejection

Brisbane, CA Testing Real-time PCR


PathVysion® HER-2 DNA Probe kit (also see under Systems below: Vysis AutoVysion™ System)

FISH PMA

Dako Denmark A/S Glostrup, Denmark DK-2600

Her2 FISH pharmDx™ Kit FISH on FFPE breast tissue

PMA

HER-2 Status

Invitrogen Carlsbad, CA

SPOT-Light HER2 CISH kit Chromogenic in situ hybridization

PMA

Biotest Diagnostics Corp. Denville, NJ

Biotest HLA SSP PCR 510(k)

Biotest Diagnostics Corp. Denville, NJ

Biotest DQB-ELPHA Enzyme linked DNA Probe Hybridization

510(k)


Dynal Reli SSO HLA-A Typing Kit PCR, Probe Hybridization

510(k)

GTI, Brookfield, WI

GTI PAT HPA-1 (P1) Genotyping kit

PCR, ELISA 510(k)


Dynal Reli SSO HLA-B Typing Kit PCR, Probe Hybridization

510(k)


Dynal Reli SSO HLA-Cw Typing Kit


510(k)


Dynal Reli SSO HLA-DQB1 Typing Kit


510(k)


Dynal Reli SSO HLA-DRB3/4/5 Typing Kit


510(k)

One Lambda, Inc. Canoga Park, CA

Micro SSP HLA Class II DNA Typing Kit

PCR 510(k)

HLA Typing

Pel-Freez Clinical Systems, LLC Milwaukee, WI

Pel Freez HLA High Resolution SSP UniTray

PCR 510(k)

MTHFR - 5,10- Nanosphere, Inc. Verigene® MTHFR Nucleic Acid Multiplex Gold 510(k)

methylenetetra hydrofolate reductase

Northbrook, IL Test (also see under Systems below: Verigene® System)

Nanoparticle Probes

Prenatal (Chromosome 13, 18, 21, X & Y)


AneuVysion® FISH 510(k)

Sex Mismatched Bone-Marrow Transplantation


CEP®X/Y DNA Probe Kit FISH 510(k)

Tissue of Origin Test for use in determining the origin of uncertain tumors

Pathwork Diagnostics, Inc. Sunnyvale, CA

Pathwork® Tissue of Origin Test Gene expression microarray

510(k)

MOLECULAR DIAGNOSTIC CONTROLS & PROFICIENCY PANELS TYPE OF CONTROL MANUFACTURER CONTROL NAME APPROVED

USE REGULATORY

ROUTE FOR PREMARKET

REVIEW Bio-Rad Laboratories Irvine, CA

Amplichek CT/GC Controls For diagnostic test kits that detect C. trachomatis and N. gonorrhoeae from swabs or urine

510(k) C. trachomatis and N. gonorrhoeae Controls (positive and negative controls)

SeraCare Life Sciences West Bridgewater, MA

ACCURUN 341 CT/NG Positive Control

For diagnostic test kits that detect CT/NG

510(k)

Cystic Fibrosis Genotyping Control

Maine Molecular Quality Controls, Inc. Scarborough, ME

INTROL™ CF Panel I Control For monitoring analytical performance of CF diagnostic assays

510(k)


CYP2D6 *4A/*2AxN For diagnostic testing for the Cytochrome P450 2D6 gene

510(k)


CYP2D6 *2M/*17 For diagnostic testing for the Cytochrome P450 2D6 gene

510(k)


CYP2D6 *29/*2AxN For diagnostic testing for the Cytochrome P450 2D6 gene

510(k)


CYP2D6 *6B/*41 For diagnostic testing for the Cytochrome P450 2D6 gene

510(k)


CYP2D6 *1/*5 For diagnostic testing for the Cytochrome P450 2D6 gene

510(k)

Cytochrome P450 2D6 gene (CYP2D6)


CYP2D6 *3A/*4A For diagnostic testing for the Cytochrome P450 2D6 gene

510(k)

Factor V and Factor II Controls

Instrumentation Laboratory Co. Bedford, MA

HemosIL FII & FV DNA Control For use on the GeneXpert® Dx System

510(k)

AcroMetrix Benicia, CA

OptiQual™ HBV DNA Positive Control

For diagnostic test kits that detect HBV DNA

Class I exempt HBV Controls


VeriSure Pro HBV Testing in donors

510(k)


ACCURUN 325 HBV RNA Positive Control

For diagnostic test kits that detect HBV DNA

510(k)


OptiQual™ HCV RNA Positive Control

For diagnostic test kits that detect HCV RNA

Class I exempt


VeriSure Pro HCV Testing in donors

510(k)

HCV Control


ACCURUN 305 HCV RNA Positive Control

For diagnostic test kits that detect HCV RNA

510(k)

HIV-1 Control AcroMetrix Benicia, CA

OptiQual™ HIV-1 RNA Positive Control

Control ranges to quantitate HIV-1 RNA

Class I exempt


VeriSure Pro HIV-1 Testing in donors

510(k) HIV-1/HCV Controls


Chiron Procleix HIV-1/HCV Controls

Testing in donors

510(k)

HIV-1/HCV Proficiency Panel


Chiron Procleix HIV-1/HCV Proficiency Panel

HIV-1/HCV Proficicncy Panel

510(k)

HIV-1/HCV/HBV Controls AcroMetrix Benicia, CA

VeriSure Pro Negative Testing in donors

510(k)


ACCURUN 345 HIV-1 RNA, HCV RNA, HBV DNA Positive Quality Control Series 150

For diagnostic test kits that detect HIV-1 RNA, HCV RNA, and HBV DNA

510(k)


ACCURUN 810 Nucleic Acid Negative Quality Control (HIV-1, HCV, HBV)

For diagnostic test kits that detect HIV-1 RNA, HCV RNA, and HBV DNA

510(k)


ACCURUN 370 HPV DNA Positive Quality Control

For in vitro tests that detect HPV DNA in human cervical samples

510(k) HPV DNA Controls


ACCURUN 378 HPV DNA Positive Quality Control

For in vitro tests that detect HPV DNA in human cervical samples

510(k)

Human Genomic DNA Control


Gentrisure™ Human Genomic DNA Reference Control

For quality control of human DNA tests

510(k)

Real-Time PCR Internal Control

Nanogen, Inc San Diego, CA

Real-Time PCR Internal Control 2B Set

For use as an unassayed internal extraction and amplification process control in real-time PCR assays

510(k)


VeriSure Pro WNV External Controls

For use with the Procleix WNV Assay to detect WNV RNA in human plasma from blood donors.

510(k)


ACCURUN 365 West Nile Virus RNA Positive quality Control

For in vitro tests that detect West Nile RNA in human plasma from blood donors

510(k)

West Nile Virus RNA Controls


ACCURUN 865 West Nile Virus RNA Negative quality Control

For in vitro tests that detect West Nile RNA in human plasma from blood donors

501(k)

MOLECULAR DIAGNOSTIC SYSTEMS TYPE OF SYSTEM MANUFACTURER SYSTEM NAME APPROVED

USE REGULATORY ROUTE

FOR PREMARKET REVIEW


BD Viper™ System BD’s Chlamydia trachomatis and Neisseria gonorrhoeae

510(k)


NucliSENS EasyQ® System NucliSENS EasyQ® Enterovirus

510(k)


TIGRIS® DTS™ System Gen-Probe’s APTIMA Combo 2® Ct/Ng Assay

510(k)


Procleix® Semi-Automated Instrument System

For Donated Blood with the PROCLEX® HIV-1/HCV Assay, the PROCLEIX ULTRIO® Assay (HIV-1, HCV and HBV)

510(k)


Procleix® TIGRIS Instrument System

For Donated Blood with the PROCLEX® HIV-1/HCV Assay, the PROCLEIX ULTRIO® Assay (HIV-1, HCV and HBV) and Procleix® WNV Assay

510(k)

Amplified Molecular Diagnostic Testing Instruments (for real-time PCR systems - see below)


VERSANT™ 440 Molecular System

VERSANT HCV RNA 3.0 assay

510(k)

Extraction Systems Qiagen, Inc. Germantown, MD

QIAcube PAXgene Blood RNA System

510(k)

Microarray and High-Multiplex Systems

Affymetrix, Inc. Santa Clara, CA

Affymetrix GCS 3000Dx Instrumentation System

AmpliChip Cytochrome P450

510(k)

and Roche Diagnostics Pleasanton, CA

Genotyping Test


INFINITI™ Analyzer

INFINITI™ Factor II (Prothrombin) Factor V Leiden, Warfarin and CYP2C19 Assay

510(k)

Luminex Corp. Toronto, Canada

Luminex LX 100/200 ID-Tag™ respiratory virus panel

510(k)


Verigene® System (inclusive of the Verigene® Reader, Verigene® Processor and Verigene® Processor SP)

Verigene® Factor V*, Factor II*, MTHFR*, Warfarin*, CFTR*, CFTR POLYT* and Respiratory Viral Panel

510(k)


eSensor® 4800 System CFTR and Warfarin

510(k)


eSensor® XT-8 System CFTR and Warfarin

510(k)

Real-Time PCR Amplification Systems


Abbott m2000™ (m2000sp + m2000rt)

Abbott Real-time HIV-1, Abbott Real-time HBV, Abbott Real-Time CT/NG

PMA

Applied Biosystems, Inc Foster City, CA

7500 Fast Dx Real-Time PCR Instrument

Human Influenza Virus Real-Time RT-PCR Detection and Characterization Panel

510(k)


GeneXpert™ Real-time PCR System

Xpert van A, Xpert C. difficile, Xpert MRSA, Xpert MRSA/SA SSTI, Xpert MRSA/SA BC, Xpert EV, Xpert GBS, Xpert Hemosil Factor II & Factor V Assay

510(k)


SmartCycler® Real-time PCR System

Smart GBS 510(k)

Focus Diagnostics Cypress, CA

3M Integrated Cycler Simplexa™ reagent kits and assay protocols labeled for in vitro use

510(k)


COBAS® AmpliPrep/COBAS® TaqMan

COBAS® AmpliPrep/ COBAS® TaqMan HIV-1 Test and COBAS AmpliPrep/COBAS TaqMan HCV Test

HIV-1 PMA and HCV 510(k)


LightCycler Instrument v. 1.2 Factor II (prothrombin) G20210A kit and Factor V Leiden kit

510(k)


LightCycler Instrument v. 2.0 MRSA Advanced 510(k)


Vysis AutoVysion™ System Vysis PathVysion® HER-2 DNA Probe Kit

510(k)

FISH Scanning Platform BioView, Ltd. Nes Ziona, Israel

BioView Duet Scanning System Peripheral blood and bone marrow (hematological probes), amniotic fluids (x,y,18, 13, and 21 probes), urine (Vysis UroVysion® probe)

510(k)

*Not yet available on the Verigene Processor SP Tables prepared by: Last updated: Nov 10, 2010

Carol A. Holland, Ph.D. [email protected]

fda-cleared/approved molecular - harrison...

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