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CLSI-FDARecognized Consensus Standards

Updated July 2013

A quick reference tool for those seeking information on FDA-recognized CLSI consensus standards.

1CLSI-FDARecognized Consensus Standards

The US Food and Drug Administration (FDA) maintains a database of recognized consensus standards, which includes more than 100 CLSI consensus standards and guidelines. The CLSI-FDARecognized Consensus Standards is a quick reference tool for those seeking information on FDA-recognized CLSI consensus standards.

If there are any discrepancies between the CLSI-FDARecognized Consensus Standards and the FDA Recognized Consensus Standards Database, the FDA database should be regarded as the definitive source.

FDA Recognized Consensus Standards Database:www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/search.cfm

Access the CLSI-FDARecognized Consensus Standards on the CLSI website: www.clsi.org

Note: The FDA Publication Date is the date the FDA either recognized the document or made a change to the documents profile. It is not the CLSI publication date.

US Food and Drug Administration Center for Devices and Radiological Health

2

Number Product Area Title of Standard or Guideline Reference Number

CLSI Code or Edition Changes

FDA Publication

DateAutomation and Informatics

13-10 Software Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard AUTO01-A 9/9/2008

13-9 Software Laboratory Automation: Bar Codes for Specimen Container Identification; Approved StandardSecond Edition AUTO02-A2 9/9/2008

13-30 SoftwareLaboratory Automation: Communications With Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved StandardSecond Edition

AUTO03-A2 3/16/2012

13-12 Software Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard AUTO04-A 9/9/2008

13-13 Software Laboratory Automation: Electromechanical Interfaces; Approved Standard AUTO05-A 9/9/200813-25 Software Managing and Validating Laboratory Information Systems; Approved Guideline AUTO08-A 3/18/2009

13-28 Software Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard AUTO09-A 3/18/2009

13-26 Software Autoverification of Clinical Laboratory Test Results; Approved Guideline AUTO10-A 3/18/2009

13-27 Software IT Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard AUTO11-A 3/18/2009

13-31 Software Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard AUTO12-A 8/20/2012

13-15 SoftwareLaboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring; Approved GuidelineSecond Edition

GP19-A2 AUTO13-A2* 9/9/2008

13-29 Software Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems; Approved StandardSecond Edition LIS01-A2 9/8/2009

13-17 Software Specification for Transferring Information Between Clinical Laboratory Instruments and Information Systems; Approved StandardSecond Edition LIS02-A2 9/9/2008

13-18 Software Standard Guide for Selection of a Clinical Laboratory Information Management System LIS03-A 9/9/2008

13-19 Software Standard Guide for Documentation of Clinical Laboratory Computer Systems LIS04-A 9/9/2008

13-20 Software Standand Specification for Transferring Clinical Observations Between Independent Computer Systems LIS05-A 9/9/2008

13-21 Software Standard Practice for Reporting Reliability of Clinical Laboratory Information System LIS06-A 9/9/2008

* CLSI code changes refer to internal recategorization of CLSI documents. The standards and guidelines have remained the same and are still FDA recognized.

US Food and Drug Administration Center for Devices and Radiological Health

3

Number Product Area Title of Standard or Guideline Reference Number

CLSI Code or Edition Changes

FDA Publication

Date13-22 Software Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory LIS07-A 9/9/2008

13-23 Software Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems LIS08-A 9/9/2008

13-24 Software Standard Guide for Coordination of Clinical Laboratory Services within the Electronic Health Record Environment and Networked Architectures LIS09-A 9/9/2008

Clinical Chemistry and Toxicology

7-149 In Vitro Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions; Approved GuidelineThird Edition C24-A3 9/9/2008

7-211 In Vitro Sweat Testing: Sample Testing: Sample Collection and Quantitative Chloride Analysis; Approved GuidelineThird Edition C34-A3 10/4/2010

7-21 In Vitro Erythrocyte Protoporphyrin Testing; Approved Guideline C42-A 9/9/20087-173 In Vitro Harmonization of Glycohemoglobin Measurements; Approved Guideline C44-A 3/18/2009

7-175 In Vitro Apolipoprotein Immunoassays: Development and Recommended Performance Characteristics; Approved Guideline I/LA15-A C59-A* 3/18/2009

7-48 In Vitro Blood Alcohol Testing in the Clinical Laboratory; Approved Guideline T/DM06-A C60-A* 11/3/2006

General Laboratory7-207 In Vitro Urinalysis; Approved GuidelineThird Edition GP16-A3 5/5/20107-166 In Vitro Fine Needle Aspiration Biopsy (FNAB) Techniques; Approved GuidelineSecond Edition GP20-A2 9/9/2008

7-167 In Vitro Nongynecologic Cytologic Specimens: Collection and Cytopreparatory Techniques; Approved Guideline GP23-A 9/9/2008

7-139 In Vitro Using Proficiency Testing to Improve the Clinical Laboratory; Approved GuidelineSecond Edition GP27-A2 9/9/2008

7-164 In Vitro Microwave Device Use in the Histology Laboratory; Approved Guideline GP28-A 3/18/2009

7-225 In Vitro Validation and Verification of Tubes for Venous and Capillary Blood Specimen Collection; Approved Guideline GP34-A 3/16/2012

7-221 In Vitro Tubes and Additives for Venous and Capillary Blood Specimen Collection; Approved StandardSixth Edition H01-A6 GP39-A6* 3/16/2012

7-201 In Vitro Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved StandardSixth Edition H03-A6 GP41-A6* 9/8/2009

* CLSI code changes refer to internal recategorization of CLSI documents. The standards and guidelines have remained the same and are still FDA recognized.

US Food and Drug Administration Center for Devices and Radiological Health

4

Number Product Area Title of Standard or Guideline Reference Number

CLSI Code or Edition Changes

FDA Publication

Date7-203 In Vitro Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens; Approved StandardSixth Edition H04-A6 GP42-A6* 9/8/2009

7-142 In Vitro Procedures for the Collection of Arterial Blood Specimens; Approved StandardFourth Edition H11-A4 GP43-A4* 9/9/2008

7-213 In Vitro Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved GuidelineFourth Edition H18-A4 GP44-A4* 8/20/2012

Hematology

7-71 In Vitro Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved StandardThird Edition H15-A3 3/18/2009

7-165 In Vitro Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved StandardSecond Edition H20-A2 9/9/2008

7-159 In VitroCollection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays; Approved GuidelineFifth Edition

H21-A5 3/16/2012

7-210 In Vitro Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Approved StandardSecond Edition H26-A2 10/4/2010

7-145 In Vitro Enumeration of Immunologically Defined Cell Populations by Flow Cytometry; Approved GuidelineSecond Edition H42-A2 3/18/2008

7-150 In Vitro Clinical Flow Cytometric Analysis of Neoplastic Hematolymphoid Cells; Approved GuidelineSecond Edition H43-A2 9/9/2008

7-135 In Vitro Methods for Reticulocyte Counting (Automated Blood Cell Counters, Flow Cytometry, and Supravital Dyes); Approved GuidelineSecond Edition H44-A2 9/9/2008

7-205 In Vitro One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved GuidelineSecond Edition H47-A2 5/5/2010

7-163 In Vitro Body Fluid Analysis for Cellular Composition; Approved Guideline H56-A 9/9/2008

7-220 In Vitro Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease; Approved Guideline H59-A 8/2/2012

Immunology and Ligand Assay

7-136 In VitroQuality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1) Indirect Fluorescence Assay for Microscopy and (2) Microtiter Enzyme Immunoassay Methods; Approved GuidelineSecond Edition

I/LA02-A2 9/9/2008

7-131 In Vitro Specifications for Immunological Testing for Infectious Diseases; Approved GuidelineSecond Edition I/LA18-A2 9/9/2008

* CLSI code changes refer to internal recategorization of CLSI documents. The standards and guidelines have remained the same and are still FDA recognized.

US Food and Drug Administration Center for Devices and Radiological Health

5

Number Product Area Title of Standard or Guideline Reference Number

CLSI Code or Edition Changes

FDA Publication

Date

7-206 In VitroAnalytical Performance Characteristics and Clinical Utility of Immunological Assays for Human Immunoglobulin E (IgE) Antibodies and Defined Allergen Specificities; Approved GuidelineSecond Edition

I/LA20-A2 5/5/2010

7-170 In Vitro Clinical Evaluation of Immunoassays; Approved GuidelineSecond Edition I/LA21-A2 3/18/2009

7-113 In Vitro Assessing the Quality of Immunoassay Systems: Radioimmunoassays, and Enzyme, Fluorescence, and Luminescence Immunoassays; Approved Guideline I/LA23-A 10/31/2005

7-219 In Vitro Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved GuidelineSecond Edition I/LA28-A2 8/2/2012

7-176 In Vitro Immunoassay Interference by Endogenous Antibodies; Approved Guideline I/LA30-A 3/18/2009

Method Evaluation

7-110 In Vitro Evaluation of Precision Performance of Quantitative Measurement Methods; Approved GuidelineSecond Edition EP05-A2 10/31/2005

7-193 In Vitro Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline EP06-A 3/18/2009

7-127 In Vitro Interference Testing in Clinical Chemistry; Approved GuidelineSecond Edition EP07-A2 5/21/2007

7-152 In Vitro User Protocol for Evaluation of Qualitative Test Performance; Approved GuidelineSecond Edition EP12-A2 9/9/2008

7-143 In Vitro Evaluation of Matrix Effects; Approved GuidelineSecond Edition EP14-A2 9/9/2008

7-153 In Vitro User Verification of Performance for Precision and Trueness; Approved GuidelineSecond Edition EP15-A2 9/9/2008

7-233 In Vitro Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved GuidelineSecond Edition EP17-A2 1/15/2013

7-212 In Vitro Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved GuidelineSecond Edition EP18-A2 10/4/2010

7-174 In Vitro Estimation of Total Analytical Error for Clinical Laboratory Methods; Approved Guideline EP21-A 3/18/2009

7-235 In Vitro Laboratory Quality Control Based on Risk Management; Approved Guideline EP23-A 1/15/2013

7-234 In Vitro Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved GuidelineSecond Edition EP24-A2 1/15/2013

7-224 In Vitro Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved GuidelineThird Edition C28-A3c EP28-A3c* 3/16/2012

7-239 In Vitro Metrological Traceability and Its Implementation; A Report X05-R EP32-R* 1/15/2013

* CLSI code changes refer to internal recategorization of CLSI documents. The standards and guidelines have remained the same and are still FDA recognized.

US Food and Drug Administration Center for Devices and Radiological Health

6

Number Product Area Title of Standard or Guideline Reference Number

CLSI Code or Edition Changes

FDA Publication

DateMicrobiology

7-229 In Vitro Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved StandardEleventh Edition M02-A11 8/20/2012

7-146 In Vitro Protocols for Evaluating Dehydrated Mueller-Hinton Agar; Approved StandardSecond Edition M06-A2 9/9/2008

7-230 In Vitro Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved StandardNinth Edition M07-A9 8/20/2012

7-228 In Vitro Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved StandardEighth Edition M11-A8 8/20/2012

7-76 In Vitro Laboratory Diagnosis of Blood-borne Parasitic Diseases; Approved Guideline M15-A 3/11/2003

7-178 In Vitro Quality Control for Commercially Prepared Microbiological Culture Media; Approved StandardThird Edition M22-A3 3/18/2009

7-198 In Vitro Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters; Approved GuidelineThird Edition M23-A3 9/8/2009

7-222 In Vitro Susceptibility Testing of Mycobacteria, Nocardiae, and other Aerobic Actinomycetes; Approved StandardSecond Edition M24-A2 3/16/2012

7-204 In Vitro Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Approved StandardThird Edition M27-A3 3/16/2012

7-179 In Vitro Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Fourth Informational Supplement M27-S3 M27-S4 3/18/2009

7-148 In Vitro Procedures for the Recovery and Identification of Parasites From the Intestinal Tract; Approved GuidelineSecond Edition M28-A2 9/9/2008

7-180 In Vitro Western Blot Assay for Antibodies to Borrelia burgdorferi; Approved Guideline M34-A 3/18/20097-197 In Vitro Abbreviated Identification of Bacteria and Yeast; Approved GuidelineSecond Edition M35-A2 9/8/2009

7-182 In Vitro Clinical Use and Interpretation of Serologic Tests for Toxoplasma gondii; Approved Guideline M36-A 3/18/2009

7-171 In Vitro Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi; Approved StandardSecond Edition M38-A2 3/18/2009

7-184 In Vitro Quality Control of Microbiological Transport Systems; Approved Standard M40-A 3/18/20097-185 In Vitro Viral Culture; Approved Guideline M41-A 3/18/2009

7-236 In Vitro Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline M43-A 1/15/2013

This is a new edition of a previously FDA-recognized document still undergoing review by the FDA. It will be posted on the FDA website when the new edition is formally recognized.

US Food and Drug Administration Center for Devices and Radiological Health

7

Number Product Area Title of Standard or Guideline Reference Number

CLSI Code or Edition Changes

FDA Publication

Date7-215 In Vitro Method for Antifungal Disk Diffusion Susceptibility Testing of Yeast; Approved GuidelineSecond Edition M44-A2 8/20/2012

7-217 In VitroZone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration (MIC) Interpretive Breakpoints, and Quality Control Limits for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Third Informational Supplement

M44-S3 8/20/2012

7-218 In Vitro Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved GuidelineSecond Edition M45-A2 8/20/2012

7-189 In Vitro Principles and Procedures for Blood Cultures; Approved Guideline M47-A 3/18/2009

7-200 In Vitro Laboratory Detection and Identification of Mycobacteria; Approved Guideline M48-A 9/8/20097-190 In Vitro Quality Control for Commercial Microbial Identification Systems; Approved Guideline M50-A 3/18/2009

7-227 In Vitro Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection; Approved Guideline M53-A 3/16/2012

7-231 In Vitro Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Third Informational Supplement M100-S22 M100-S23 8/20/2012

Molecular Methods

7-237 In Vitro Molecular Methods for Clinical Genetics and Oncology Testing; Approved GuidelineThird Edition MM01-A3 1/15/2013

7-132 In Vitro Molecular Diagnostic Methods for Infectious Diseases; Approved GuidelineSecond Edition MM03-A2 9/9/2008

7-232 In Vitro Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved GuidelineSecond Edition MM05-A2 1/15/2013

7-238 In Vitro Quantitative Molecular Methods for Infectious Diseases; Approved GuidelineSecond Edition MM06-A2 1/15/2013

7-123 In Vitro Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline MM09-A 10/31/2005

7-191 In Vitro Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; Approved Guideline MM13-A 3/18/2009

7-192 In Vitro Interpretive Criteria for Identification of Bacteria and Fungi by DNA Target Sequencing; Approved Guideline MM18-A 3/18/2009

Newborn Screening

7-137 In Vitro Blood Collection on Filter Paper for Newborn Screening Programs; Approved StandardSixth Edition LA04-A5 NBS01-A6 9/9/2008

This is a new edition of a previously FDA-recognized document still undergoing review by the FDA. It will be posted on the FDA website when the new edition is formally recognized.

US Food and Drug Administration Center for Devices and Radiological Health

8

Number Product Area Title of Standard or Guideline Reference Number

CLSI Code or Edition Changes

FDA Publication

DatePoint-of-Care Testing

13-14 Software Point-of-Care Connectivity; Approved StandardSecond Edition POCT01-A2 9/9/2008

7-209 In Vitro Performance Metrics for Continuous Interstitial Glucose Monitoring; Approved Guideline POCT05-A 5/5/2010

7-162 In Vitro Point-of-Care Monitoring of Anticoagulant Therapy; Approved Guideline H49-A POCT14-A* 9/9/2008

Quality Management Systems

7-226 In Vitro Quality Management System: A Model for Laboratory Services; Approved GuidelineFourth Edition GP26-A4 QMS01-A4* 3/16/2012

7-223 In Vitro Quality Management System: Continual Improvement; Approved GuidelineThird Edition GP22-A3 QMS06-A3* 3/16/2012

* CLSI code changes refer to internal recategorization of CLSI documents. The standards and guidelines have remained the same and are still FDA recognized.