CLSI-FDA–Recognized

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

Updated July 2013

950 West Valley Road, Suite 2500, Wayne, PA 19087 | P: 610.688.0100 | Toll Free (US): 877.447.1888 | F: 610.688.0700 | E: customerservice@clsi.org
CLSI-FDA–Recognized Consensus Standards

The US Food and Drug Administration (FDA) If there are any discrepancies between the
maintains a database of recognized consensus CLSI-FDA–Recognized Consensus Standards and the
standards, which includes more than 100 CLSI FDA Recognized Consensus Standards Database,
consensus standards and guidelines. The the FDA database should be regarded as the
CLSI-FDA–Recognized Consensus Standards is a definitive source.
quick reference tool for those seeking information
on FDA-recognized CLSI consensus standards.

FDA Recognized Consensus Standards Database: Access the CLSI-FDA–Recognized Consensus Standards on
the CLSI website: www.clsi.org
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/search.cfm

Note: The FDA Publication Date is the date the FDA either recognized the document or made a change to the document’s profile. It is not the CLSI publication date.
1
 US Food and Drug Administration
Center for Devices and Radiological Health

CLSI Code FDA

or Edition Publication
Number Product Area Title of Standard or Guideline Reference Number Changes Date
Automation and Informatics

13-10 Software Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard AUTO01-A 9/9/2008
Laboratory Automation: Bar Codes for Specimen Container Identification; Approved
13-9 Software AUTO02-A2 9/9/2008
Standard—Second Edition
Laboratory Automation: Communications With Automated Clinical Laboratory
13-30 Software Systems, Instruments, Devices, and Information Systems; Approved Standard—Second AUTO03-A2 3/16/2012
Edition
Laboratory Automation: Systems Operational Requirements, Characteristics, and
13-12 Software AUTO04-A 9/9/2008
Information Elements; Approved Standard
13-13 Software Laboratory Automation: Electromechanical Interfaces; Approved Standard AUTO05-A 9/9/2008
13-25 Software Managing and Validating Laboratory Information Systems; Approved Guideline AUTO08-A 3/18/2009
Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved
13-28 Software AUTO09-A 3/18/2009
Standard
13-26 Software Autoverification of Clinical Laboratory Test Results; Approved Guideline AUTO10-A 3/18/2009
IT Security of In Vitro Diagnostic Instruments and Software Systems; Approved
13-27 Software AUTO11-A 3/18/2009
Standard
Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved
13-31 Software AUTO12-A 8/20/2012
Standard
Laboratory Instruments and Data Management Systems: Design of Software User
13-15 Software Interfaces and End-User Software Systems Validation, Operation, and Monitoring; GP19-A2 AUTO13-A2* 9/9/2008
Approved Guideline—Second Edition
Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory
13-29 Software LIS01-A2 9/8/2009
Instruments and Computer Systems; Approved Standard—Second Edition
Specification for Transferring Information Between Clinical Laboratory Instruments
13-17 Software LIS02-A2 9/9/2008
and Information Systems; Approved Standard—Second Edition
Standard Guide for Selection of a Clinical Laboratory Information Management
13-18 Software LIS03-A 9/9/2008
System
13-19 Software Standard Guide for Documentation of Clinical Laboratory Computer Systems LIS04-A 9/9/2008
Standand Specification for Transferring Clinical Observations Between Independent
13-20 Software LIS05-A 9/9/2008
Computer Systems
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.
2
 US Food and Drug Administration
Center for Devices and Radiological Health

CLSI Code FDA

or Edition Publication
Number Product Area Title of Standard or Guideline Reference Number Changes Date
Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical
13-22 Software LIS07-A 9/9/2008
Laboratory
Standard Guide for Functional Requirements of Clinical Laboratory Information
13-23 Software LIS08-A 9/9/2008
Management Systems
Standard Guide for Coordination of Clinical Laboratory Services within the Electronic
13-24 Software LIS09-A 9/9/2008
Health Record Environment and Networked Architectures

Clinical Chemistry and Toxicology

Statistical Quality Control for Quantitative Measurement Procedures: Principles and

7-149 In Vitro C24-A3 9/9/2008
Definitions; Approved Guideline—Third Edition
Sweat Testing: Sample Testing: Sample Collection and Quantitative Chloride Analysis;
7-211 In Vitro C34-A3 10/4/2010
Approved Guideline—Third Edition
7-21 In Vitro Erythrocyte Protoporphyrin Testing; Approved Guideline C42-A 9/9/2008
7-173 In Vitro Harmonization of Glycohemoglobin Measurements; Approved Guideline C44-A 3/18/2009
Apolipoprotein Immunoassays: Development and Recommended Performance
7-175 In Vitro I/LA15-A C59-A* 3/18/2009
Characteristics; Approved Guideline

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

General Laboratory
7-207 In Vitro Urinalysis; Approved Guideline—Third Edition GP16-A3 5/5/2010
7-166 In Vitro Fine Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline—Second Edition GP20-A2 9/9/2008
Nongynecologic Cytologic Specimens: Collection and Cytopreparatory Techniques;
7-167 In Vitro GP23-A 9/9/2008
Approved Guideline
Using Proficiency Testing to Improve the Clinical Laboratory; Approved Guideline—
7-139 In Vitro GP27-A2 9/9/2008
Second Edition
7-164 In Vitro Microwave Device Use in the Histology Laboratory; Approved Guideline GP28-A 3/18/2009
Validation and Verification of Tubes for Venous and Capillary Blood Specimen
7-225 In Vitro GP34-A 3/16/2012
Collection; Approved Guideline
Tubes and Additives for Venous and Capillary Blood Specimen Collection; Approved
7-221 In Vitro H01-A6 GP39-A6* 3/16/2012
Standard—Sixth Edition
Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture;
7-201 In Vitro H03-A6 GP41-A6* 9/8/2009
Approved Standard—Sixth Edition

* CLSI code changes refer to internal recategorization of CLSI documents. The standards and guidelines have remained the same and are still FDA recognized.
3
 US Food and Drug Administration
Center for Devices and Radiological Health

CLSI Code FDA

or Edition Publication
Number Product Area Title of Standard or Guideline Reference Number Changes Date
Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens;
7-203 In Vitro H04-A6 GP42-A6* 9/8/2009
Approved Standard—Sixth Edition
Procedures for the Collection of Arterial Blood Specimens; Approved Standard—Fourth
7-142 In Vitro H11-A4 GP43-A4* 9/9/2008
Edition
Procedures for the Handling and Processing of Blood Specimens for Common
7-213 In Vitro H18-A4 GP44-A4* 8/20/2012
Laboratory Tests; Approved Guideline—Fourth Edition

Hematology

Reference and Selected Procedures for the Quantitative Determination of Hemoglobin

7-71 In Vitro H15-A3 3/18/2009
in Blood; Approved Standard—Third Edition
Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of
7-165 In Vitro H20-A2 9/9/2008
Instrumental Methods; Approved Standard—Second Edition
Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based
7-159 In Vitro Coagulation Assays and Molecular Hemostasis Assays; Approved Guideline—Fifth H21-A5 3/16/2012
Edition
Validation, Verification, and Quality Assurance of Automated Hematology Analyzers;
7-210 In Vitro H26-A2 10/4/2010
Approved Standard—Second Edition
Enumeration of Immunologically Defined Cell Populations by Flow Cytometry;
7-145 In Vitro H42-A2 3/18/2008
Approved Guideline—Second Edition
Clinical Flow Cytometric Analysis of Neoplastic Hematolymphoid Cells; Approved
7-150 In Vitro H43-A2 9/9/2008
Guideline—Second Edition
Methods for Reticulocyte Counting (Automated Blood Cell Counters, Flow Cytometry,
7-135 In Vitro H44-A2 9/9/2008
and Supravital Dyes); Approved Guideline—Second Edition
One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time
7-205 In Vitro H47-A2 5/5/2010
(APTT) Test; Approved Guideline—Second Edition
7-163 In Vitro Body Fluid Analysis for Cellular Composition; Approved Guideline H56-A 9/9/2008
Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease; Approved
7-220 In Vitro H59-A 8/2/2012
Guideline
Immunology and Ligand Assay
Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1)
7-136 In Vitro Indirect Fluorescence Assay for Microscopy and (2) Microtiter Enzyme Immunoassay I/LA02-A2 9/9/2008
Methods; Approved Guideline—Second Edition
Specifications for Immunological Testing for Infectious Diseases; Approved
7-131 In Vitro I/LA18-A2 9/9/2008
Guideline—Second Edition

* CLSI code changes refer to internal recategorization of CLSI documents. The standards and guidelines have remained the same and are still FDA recognized.
4
 US Food and Drug Administration
Center for Devices and Radiological Health

CLSI Code FDA

or Edition Publication
Number Product Area Title of Standard or Guideline Reference Number Changes Date
Analytical Performance Characteristics and Clinical Utility of Immunological Assays
7-206 In Vitro for Human Immunoglobulin E (IgE) Antibodies and Defined Allergen Specificities; I/LA20-A2 5/5/2010
Approved Guideline—Second Edition
7-170 In Vitro Clinical Evaluation of Immunoassays; Approved Guideline—Second Edition I/LA21-A2 3/18/2009
Assessing the Quality of Immunoassay Systems: Radioimmunoassays, and Enzyme,
7-113 In Vitro I/LA23-A 10/31/2005
Fluorescence, and Luminescence Immunoassays; Approved Guideline
Quality Assurance for Design Control and Implementation of Immunohistochemistry
7-219 In Vitro I/LA28-A2 8/2/2012
Assays; Approved Guideline—Second Edition
7-176 In Vitro Immunoassay Interference by Endogenous Antibodies; Approved Guideline I/LA30-A 3/18/2009
Method Evaluation
Evaluation of Precision Performance of Quantitative Measurement Methods; Approved
7-110 In Vitro EP05-A2 10/31/2005
Guideline—Second Edition
Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical
7-193 In Vitro EP06-A 3/18/2009
Approach; Approved Guideline
7-127 In Vitro Interference Testing in Clinical Chemistry; Approved Guideline—Second Edition EP07-A2 5/21/2007
User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline—
7-152 In Vitro EP12-A2 9/9/2008
Second Edition
7-143 In Vitro Evaluation of Matrix Effects; Approved Guideline—Second Edition EP14-A2 9/9/2008
User Verification of Performance for Precision and Trueness; Approved Guideline—
7-153 In Vitro EP15-A2 9/9/2008
Second Edition
Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures;
7-233 In Vitro EP17-A2 1/15/2013
Approved Guideline—Second Edition
Risk Management Techniques to Identify and Control Laboratory Error Sources;
7-212 In Vitro EP18-A2 10/4/2010
Approved Guideline—Second Edition
Estimation of Total Analytical Error for Clinical Laboratory Methods; Approved
7-174 In Vitro EP21-A 3/18/2009
Guideline
7-235 In Vitro Laboratory Quality Control Based on Risk Management; Approved Guideline EP23-A™ 1/15/2013
Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating
7-234 In Vitro EP24-A2 1/15/2013
Characteristic Curves; Approved Guideline—Second Edition
Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory;
7-224 In Vitro C28-A3c EP28-A3c* 3/16/2012
Approved Guideline—Third Edition
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.
5
 US Food and Drug Administration
Center for Devices and Radiological Health

CLSI Code FDA

or Edition Publication
Number Product Area Title of Standard or Guideline Reference Number Changes Date
Microbiology
Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved
7-229 In Vitro M02-A11 8/20/2012
Standard—Eleventh Edition
Protocols for Evaluating Dehydrated Mueller-Hinton Agar; Approved Standard—
7-146 In Vitro M06-A2 9/9/2008
Second Edition
Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow
7-230 In Vitro M07-A9 8/20/2012
Aerobically; Approved Standard—Ninth Edition
Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved
7-228 In Vitro M11-A8 8/20/2012
Standard—Eighth Edition
7-76 In Vitro Laboratory Diagnosis of Blood-borne Parasitic Diseases; Approved Guideline M15-A 3/11/2003
Quality Control for Commercially Prepared Microbiological Culture Media; Approved
7-178 In Vitro M22-A3 3/18/2009
Standard—Third Edition
Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters;
7-198 In Vitro M23-A3 9/8/2009
Approved Guideline—Third Edition
Susceptibility Testing of Mycobacteria, Nocardiae, and other Aerobic Actinomycetes;
7-222 In Vitro M24-A2 3/16/2012
Approved Standard—Second Edition
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts;
7-204 In Vitro M27-A3 3/16/2012
Approved Standard—Third Edition
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Fourth
7-179 In Vitro M27-S3 M27-S4† 3/18/2009
Informational Supplement
Procedures for the Recovery and Identification of Parasites From the Intestinal Tract;
7-148 In Vitro M28-A2 9/9/2008
Approved Guideline—Second Edition
7-180 In Vitro Western Blot Assay for Antibodies to Borrelia burgdorferi; Approved Guideline M34-A 3/18/2009
7-197 In Vitro Abbreviated Identification of Bacteria and Yeast; Approved Guideline—Second Edition M35-A2 9/8/2009
Clinical Use and Interpretation of Serologic Tests for Toxoplasma gondii; Approved
7-182 In Vitro M36-A 3/18/2009
Guideline
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous
7-171 In Vitro M38-A2 3/18/2009
Fungi; Approved Standard—Second Edition
7-184 In Vitro Quality Control of Microbiological Transport Systems; Approved Standard M40-A 3/18/2009
7-185 In Vitro Viral Culture; Approved Guideline M41-A 3/18/2009
Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved
7-236 In Vitro M43-A 1/15/2013
Guideline

†
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.
6
 US Food and Drug Administration
Center for Devices and Radiological Health

CLSI Code FDA

or Edition Publication
Number Product Area Title of Standard or Guideline Reference Number Changes Date
Method for Antifungal Disk Diffusion Susceptibility Testing of Yeast; Approved
7-215 In Vitro M44-A2 8/20/2012
Guideline—Second Edition
Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory
7-217 In Vitro Concentration (MIC) Interpretive Breakpoints, and Quality Control Limits for Antifungal M44-S3 8/20/2012
Disk Diffusion Susceptibility Testing of Yeasts; Third Informational Supplement
Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently
7-218 In Vitro M45-A2 8/20/2012
Isolated or Fastidious Bacteria; Approved Guideline—Second Edition
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 9/8/2009
7-190 In Vitro Quality Control for Commercial Microbial Identification Systems; Approved Guideline M50-A 3/18/2009
Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus
7-227 In Vitro M53-A 3/16/2012
Infection; Approved Guideline
Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Third
7-231 In Vitro M100-S22 M100-S23† 8/20/2012
Informational Supplement
Molecular Methods
Molecular Methods for Clinical Genetics and Oncology Testing; Approved Guideline—
7-237 In Vitro MM01-A3 1/15/2013
Third Edition
Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline—Second
7-132 In Vitro MM03-A2 9/9/2008
Edition
Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved
7-232 In Vitro MM05-A2 1/15/2013
Guideline—Second Edition
Quantitative Molecular Methods for Infectious Diseases; Approved Guideline—Second
7-238 In Vitro MM06-A2 1/15/2013
Edition
Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved
7-123 In Vitro MM09-A 10/31/2005
Guideline
Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods;
7-191 In Vitro MM13-A 3/18/2009
Approved Guideline
Interpretive Criteria for Identification of Bacteria and Fungi by DNA Target Sequencing;
7-192 In Vitro MM18-A 3/18/2009
Approved Guideline
Newborn Screening
Blood Collection on Filter Paper for Newborn Screening Programs; Approved
7-137 In Vitro LA04-A5 NBS01-A6† 9/9/2008
Standard—Sixth Edition

†
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.
7
 US Food and Drug Administration
Center for Devices and Radiological Health

CLSI Code FDA

or Edition Publication
Number Product Area Title of Standard or Guideline Reference Number Changes Date
Point-of-Care Testing
13-14 Software Point-of-Care Connectivity; Approved Standard—Second Edition POCT01-A2 9/9/2008
Performance Metrics for Continuous Interstitial Glucose Monitoring; Approved
7-209 In Vitro POCT05-A 5/5/2010
Guideline
7-162 In Vitro Point-of-Care Monitoring of Anticoagulant Therapy; Approved Guideline H49-A POCT14-A* 9/9/2008
Quality Management Systems
Quality Management System: A Model for Laboratory Services; Approved Guideline—
7-226 In Vitro GP26-A4 QMS01-A4* 3/16/2012
Fourth Edition
Quality Management System: Continual Improvement; Approved Guideline—Third
7-223 In Vitro GP22-A3 QMS06-A3* 3/16/2012
Edition

* CLSI code changes refer to internal recategorization of CLSI documents. The standards and guidelines have remained the same and are still FDA recognized.
8