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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.
1
CLSI-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
denitive 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 prole. 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
Date
Automation 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 Identifcation; Approved
StandardSecond Edition
AUTO02-A2 9/9/2008
13-30 Software
Laboratory 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 9/9/2008
13-25 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 Autoverifcation 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 Software
Laboratory 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
Specifcation 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
Specifcation 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 Specifcation 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
Date
13-22 Software
Standard Specifcation 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
Defnitions; 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 9/9/2008
7-173 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 Laboratory
7-207 In Vitro Urinalysis; Approved GuidelineThird Edition GP16-A3 5/5/2010
7-166 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 Profciency Testing to Improve the Clinical Laboratory; Approved Guideline
Second 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 Verifcation 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
Date
7-203 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) Dierential Count (Proportional) and Evaluation of
Instrumental Methods; Approved StandardSecond Edition
H20-A2 9/9/2008
7-159 In Vitro
Collection, 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, Verifcation, and Quality Assurance of Automated Hematology Analyzers;
Approved StandardSecond Edition
H26-A2 10/4/2010
7-145 In Vitro
Enumeration of Immunologically Defned 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 Vitro
Quality 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
Specifcations 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 Vitro
Analytical Performance Characteristics and Clinical Utility of Immunological Assays
for Human Immunoglobulin E (IgE) Antibodies and Defned Allergen Specifcities;
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 Guideline
Second Edition
EP12-A2 9/9/2008
7-143 In Vitro Evaluation of Matrix Eects; Approved GuidelineSecond Edition EP14-A2 9/9/2008
7-153 In Vitro
User Verifcation of Performance for Precision and Trueness; Approved Guideline
Second 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
Defning, 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
Date
Microbiology
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 Standard
Second 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 Identifcation 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 3/18/2009
7-197 In Vitro Abbreviated Identifcation 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 3/18/2009
7-185 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
Date
7-215 In Vitro
Method for Antifungal Disk Diusion Susceptibility Testing of Yeast; Approved
GuidelineSecond Edition
M44-A2 8/20/2012
7-217 In Vitro
Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory
Concentration (MIC) Interpretive Breakpoints, and Quality Control Limits for Antifungal
Disk Diusion 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 Identifcation of Mycobacteria; Approved Guideline M48-A 9/8/2009
7-190 In Vitro Quality Control for Commercial Microbial Identifcation Systems; Approved Guideline M50-A 3/18/2009
7-227 In Vitro
Criteria for Laboratory Testing and Diagnosis of Human Immunodefciency 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 Guideline
Third 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 Amplifcation 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 Identifcation 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
Date
Point-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 Guideline
Fourth 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.