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Crosswalk of Documents Referenced Within FDA Accreditation Checklists

The US FDA identifies voluntary consensus standards for which they will accept a declaration of conformity validating that the manufacturer has met relevant requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA may recognize all, part, or none of a standard established by a national or international SDO. This crosswalk provides a quick reference to those CLSI clinical and laboratory standards recognized by the FDA.

If there are any discrepancies between the FDA-Recognized Consensus Standards and the FDA-Recognized Consensus Standards Database, the FDA database should be regarded as the definitive source.
(Note: CLSI standards and guidelines can be located in the FDA database by searching on “CLSI” and/or “NCCLS.”)

To view each checklist area, click "Filter Off" and select from the dropdown options.

Product Code
Former Code
DL Title
Specialty Task Group
Date of Recognition
Recognition Number
Type of Recognition
Publication Date
Product Status
AUTO02-A2
 
Laboratory Automation: Bar Codes for Specimen Container Identification
Software/Informatics
2008-09-09
13-9
Complete
2006-01-06
Archived
AUTO03-A2
 
Laboratory Automation: Communications With Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems
Software/Informatics
2012-03-16
13-30
Complete
2009-09-30
Archived
AUTO04-A
 
Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements.
Software/Informatics
2008-09-09
13-12
Complete
2001-03-20
Archived
AUTO05-A
 
Laboratory Automation: Electromechanical Interfaces, 1st Edition
Software/Informatics
2008-09-09
13-13
Complete
2001-03-20
Archived
AUTO07-A
 
Laboratory Automation: Data Content for Specimen Identification
Software/Informatics
2013-08-06
13-37
Complete
2004-06-20
Archived
AUTO08-A
 
Managing and Validating Laboratory Information Systems
Software/Informatics
2009-03-18
13-25
Complete
2006-12-15
Archived
AUTO09-A
 
Remote Access to Clinical Laboratory Diagnostic Devices via the Internet
Software/Informatics
2009-03-18
13-28
Complete
2006-03-22
Archived
AUTO10-A
 
Autoverification of Clinical Laboratory Test Results
Software/Informatics
2009-03-18
13-26
Complete
2006-10-31
Archived
AUTO11-A2
 
IT Security of In Vitro Diagnostic Instruments and Software Systems
Software/Informatics
2016-12-23
13-85
Complete
2014-10-31
Active
AUTO12-A
 
Specimen Labels: Content and Location, Fonts, and Label Orientation
Software/Informatics
2012-08-20
13-31
Complete
2011-04-28
Reaffirmed
AUTO13-A2
GP19-A2
Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring
Software/Informatics
2014-07-09
13-15
Complete
2003-02-18
Archived
C24-Ed4
C24-A3
Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions
InVitro Diagnostics
2016-12-23
7-267
Complete
2016-09-29
Reaffirmed
C29-A2
C29-A
Standardization of Sodium and Potassium Ion-Selective Electrode Systems to the Flame Photometric Reference Method
InVitro Diagnostics
2004-03-08
7-86
Complete
2000-10-01
Archived
C31-A2
C31-A
Ionized Calcium Determinations: Precollection Variables, Specimen Choice, Collection, and Handling
InVitro Diagnostics
2004-03-08
7-87
Partial
2001-06-01
Archived
C34-Ed4
C34-A3
Sweat Testing: Sample Collection and Quantitative Chloride Analysis
InVitro Diagnostics
2020-12-21
7-302
Complete
2019-02-08
Active
C37-A
 
Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Measurement Procedures
InVitro Diagnostics
2004-03-08
7-88
Complete
1999-11-01
Archived
C39-A
C39-P
A Designated Comparison Method for the Measurement of Ionized Calcium in Serum
InVitro Diagnostics
2004-03-08
7-89
Complete
2000-04-01
Archived
C42-A
 
Erythrocyte Protoporphyrin Testing
InVitro Diagnostics
2008-09-09
7-21
Complete
1996-01-11
Archived
C56-A
 
Hemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of Interference in Clinical Laboratory Analysis
InVitro Diagnostics
2013-08-06
7-242
Complete
2012-07-13
Archived
C57-Ed1
 
Mass Spectrometry for Androgen and Estrogen Measurements in Serum
InVitro Diagnostics
2017-08-21
7-272
Partial
2015-02-27
Reaffirmed
C62-A
 
Liquid Chromatography-Mass Spectrometry Methods
InVitro Diagnostics
2016-09-21
7-265
Partial
2014-10-30
Replaced
EP05-A3
 
Evaluation of Precision of Quantitative Measurement Procedures
InVitro Diagnostics
2015-08-14
7-251
Complete
2014-10-01
Reaffirmed
EP06-Ed2
EP06-A
Evaluation of Linearity of Quantitative Measurement Procedures
InVitro Diagnostics
2021-06-07
7-306
Complete
2020-11-24
Active
EP07-Ed3
 
Interference Testing in Clinical Chemistry
InVitro Diagnostics
2018-09-17
7-275
Complete
2018-04-30
Reaffirmed
EP09-Ed3c
 
Measurement Procedure Comparison and Bias Estimation Using Patient Samples
InVitro Diagnostics
2020-07-06
7-296
Partial
2018-06-20
Active
EP12-Ed3
EP12-A2
Evaluation of Qualitative, Binary Output Examination Performance
InVitro Diagnostics
2023-05-29
7-315
Complete
2023-03-07
Active
EP14-A3
 
Evaluation of Commutability of Processed Sample
InVitro Diagnostics
2015-08-14
7-252
Complete
2014-08-15
Replaced
EP15-A3
 
User Verification of Precision and Estimation of Bias
InVitro Diagnostics
2015-08-14
7-253
Complete
2014-09-01
Reaffirmed
EP17-A2
 
Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures
InVitro Diagnostics
2013-01-15
7-233
Complete
2012-06-18
Reaffirmed
EP18-A2
 
Risk Management Techniques to Identify and Control Laboratory Error Sources
InVitro Diagnostics
2010-10-04
7-212
Complete
2009-11-30
Archived
EP-19-Ed2
EP19-A
A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures
InVitro Diagnostics
2016-09-21
7-266
Complete
2015-06-18
Replaced
EP21-Ed2
EP21-A
Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures
InVitro Diagnostics
2016-12-23
7-268
Complete
2016-07-01
Active
EP24-A2
GP10-A
Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves
InVitro Diagnostics
2013-08-06
7-234
Partial
2011-11-30
Reaffirmed
EP25-Ed2
EP21-A
Evaluation of Stability of In Vitro Medical Laboratory Test Reagents
InVitro Diagnostics
2023-12-18
7-318
Complete
2023-04-26
Active
EP27-Ed2
EP27-A
How to Construct and Interpret an Error Grid for Quantitative Measurement Procedures
InVitro Diagnostics
2022-12-19
7-313
Complete
2022-06-14
Active
EP28-A3c
C28-A3c
Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory
InVitro Diagnostics
2014-01-30
7-224
Complete
2010-10-01
Reaffirmed
EP32-R
X05-R
Metrological Traceability and Its Implementation
InVitro Diagnostics
2014-01-30
7-239
Complete
2006-02-17
Active
EP34-Ed1
 
Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking
InVitro Diagnostics
2019-07-15
7-290
Partial
2018-08-13
Reaffirmed
EP35-Ed1
 
Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures
InVitro Diagnostics
2020-07-06
7-298
Complete
2019-12-19
Active
EP37-Ed1
 
Supplemental Tables for Interference Testing in Clinical Chemistry
InVitro Diagnostics
2018-09-17
7-284
Complete
2018-04-30
Active
EP39-Ed1
 
A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests
InVitro Diagnostics
2021-12-20
7-311
Complete
2021-11-11
Active
GP16-A3
GP16-A2
Urinalysis
InVitro Diagnostics
2010-05-05
7-207
Complete
2009-02-05
Archived
GP20-A2
GP20-A
Fine Needle Aspiration Biopsy (FNAB) Techniques
InVitro Diagnostics
2012-03-16
7-166
Complete
2003-10-20
Archived
GP23-A2
GP23-A
Nongynecologic Cytologic Specimens: Collection and Cytopreparatory Technique
InVitro Diagnostics
2016-04-04
7-259
Partial
2014-11-24
Archived
GP34-A
GP34-P
Validation and Verification of Tubes for Venous and Capillary Blood Specimen Collection
InVitro Diagnostics
2012-03-16
7-225
Complete
2010-12-31
Reaffirmed
GP39-A6
H01-A6
Tubes and Additives for Venous and Capillary Blood Specimen Collection
InVitro Diagnostics
2014-07-09
7-221
Complete
2010-12-29
Archived
GP41-Ed7
 
Collection of Diagnostic Venous Blood Specimens
InVitro Diagnostics
2018-09-17
7-277
Complete
2017-04-15
Active
GP42-Ed7
GP42-A6
Collection of Capillary Blood Specimens
InVitro Diagnostics
2020-12-21
7-301
Complete
2020-09-16
Active
GP44-A4
GP44-A3
Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests
InVitro Diagnostics
2014-07-09
7-213
Complete
2010-05-25
Replaced
H07-A3
 
Procedure for Determining Packed Cell Volume by the Microhematocrit Method
InVitro Diagnostics
2004-10-04
7-104
Complete
2000-10-01
Archived
H15-A3
H15-A2
Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood
InVitro Diagnostics
2009-03-18
7-71
Complete
2000-12-01
Archived
H20-A2
H20-A
Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods
InVitro Diagnostics
2012-03-16
7-165
Complete
2007-01-18
Reaffirmed
H21-A5
 
Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays
InVitro Diagnostics
2008-09-09
7-159
Complete
2008-01-23
Active
H26-A2
 
Validation, Verification, and Quality Assurance of Automated Hematology Analyzers
InVitro Diagnostics
2014-01-30
7-210
Partial
2010-06-25
Reaffirmed
H30-A2
 
Procedure for the Determination of Fibrinogen in Plasma
InVitro Diagnostics
2004-10-04
7-105
Complete
2001-11-01
Archived
H42-A2
H42-A
Enumeration of Immunologically Defined Cell Populations by Flow Cytometry
InVitro Diagnostics
2009-03-18
7-145
Complete
2007-05-22
Reaffirmed
H43-A2
 
Clinical Flow Cytometric Analysis of Neoplastic Hematolymphoid Cells
InVitro Diagnostics
2012-03-16
7-150
Complete
2007-04-23
Reaffirmed
H47-A2
H47-A
One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test
InVitro Diagnostics
2010-05-05
7-205
Complete
2008-05-30
Replaced
H56-A
H56-P
Body Fluid Analysis for Cellular Composition
InVitro Diagnostics
2008-09-09
7-163
Complete
2006-07-10
Archived
H59-A
H59-P
Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease
InVitro Diagnostics
2014-01-30
7-220
Partial
2011-03-31
Reaffirmed
H62-Ed1
 
Validation of Assays Performed by Flow Cytometry
InVitro Diagnostics
2023-12-18
7-320
Partial
2021-10-27
Active
I/LA02-A2
I/LA2-A
Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1) Indirect Fluorescence Assay for Microscopy and (2) Microtiter Enzyme Immunoassay Methods
InVitro Diagnostics
2008-09-09
7-136
Complete
2006-03-22
Archived
I/LA20-Ed3
I/LA20-A3
Analytical Performance Characteristics, Quality Assurance, and Clinical Utility of Immunological Assays for Human Immunoglobulin E (IgE) Antibodies of Defined Allergen Specificities
InVitro Diagnostics
2017-08-21
7-270
Complete
2016-10-01
Active
I/LA21-A2
 
Clinical Evaluation of Immunoassays
InVitro Diagnostics
2009-03-18
7-170
Complete
2008-08-29
Archived
I/LA23-A
I/LA23-P
Assessing the Quality of Immunoassay Systems: Radioimmunoassays and Enzyme, Fluorescence, and Luminescence Immunoassays
InVitro Diagnostics
2005-11-08
7-113
 
2004-04-20
Archived
I/LA28-A2
 
Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays
InVitro Diagnostics
2011-08-02
7-219
Complete
2011-01-31
Reaffirmed
I/LA30-A
I/LA30-P
Immunoassay Interference by Endogenous Antibodies
InVitro Diagnostics
2009-03-18
7-176
Complete
2008-02-25
Archived
LIS01-A2
 
Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems
Software/Informatics
2009-09-08
13-29
Complete
2008-04-28
Archived
LIS02-A2
 
Specification for Transferring Information Between Clinical Laboratory Instruments and Information Systems
Software/Informatics
2008-09-09
13-17
Complete
2004-10-20
Archived
M02-Ed13
M02-A12
Performance Standards for Antimicrobial Disk Susceptibility Tests
InVitro Diagnostics
2018-09-17
7-280
Complete
2018-01-18
Replaced
M07-Ed11
M07-A10
Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically
InVitro Diagnostics
2018-09-17
7-279
Complete
2018-01-11
Replaced
M11-Ed9
 
Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria
InVitro Diagnostics
2019-01-14
7-286
Complete
2018-10-16
Active
M15-A
M15-T
Laboratory Diagnosis of Blood-borne Parasitic Diseases
InVitro Diagnostics
2012-08-20
7-76
Complete
2000-06-01
Archived
M22-A3
M22-A2
Quality Control for Commercially Prepared Microbiological Culture Media
InVitro Diagnostics
2019-01-14
7-178
Complete
2004-06-20
Archived
M23-Ed6
 
Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters
InVitro Diagnostics
2023-12-18
7-319
Complete
2023-07-31
Active
M23-Ed5
 
Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters
InVitro Diagnostics
2020-12-21
7-304
Complete
2018-01-16
Replaced
M24-Ed3
 
Susceptibility Testing of Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes
InVitro Diagnostics
2019-07-15
7-288
Complete
2018-11-28
Active
M27-Ed4
 
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts
InVitro Diagnostics
2018-09-17
7-278
Complete
2017-11-30
Active
M27-M44-S-Ed3
 
Performance Standards for Antifungal Susceptibility Testing of Yeasts
InVitro Diagnostics
2022-12-19
7-314
Partial
2022-08-04
Active
M28-A2
M28-A
Procedures for the Recovery and Identification of Parasites From the Intestinal Tract
InVitro Diagnostics
2012-08-20
7-148
Complete
2005-06-30
Archived
M34-A
M24-P
Western Blot Assay for Antibodies to Borrelia burgdorferi
InVitro Diagnostics
2009-03-18
7-180
Complete
2000-10-01
Archived
M35-A2
M35-A
Abbreviated Identification of Bacteria and Yeast
InVitro Diagnostics
2012-08-20
7-197
Complete
2008-11-24
Reaffirmed
M36-A
 
Clinical Use and Interpretation of Serologic Tests for Toxoplasma gondii
InVitro Diagnostics
2009-03-18
7-182
Complete
2004-02-01
Archived
M38-Ed3
 
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi
InVitro Diagnostics
2018-09-17
7-276
Complete
2017-11-30
Active
M39-Ed5
 
Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data
InVitro Diagnostics
2022-05-30
7-312
Complete
2022-01-25
Active
M40-A2
 
Quality Control of Microbiological Transport Systems
InVitro Diagnostics
2015-01-27
7-250
Partial
2014-06-23
Reaffirmed
M41-A
 
Viral Culture
InVitro Diagnostics
2009-03-18
7-185
Complete
2006-11-30
Archived
M43-A
 
Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas
InVitro Diagnostics
2021-06-07
7-236
Partial
2011-10-27
Archived
M44-A2
 
Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration (MIC) Interpretive Breakpoints, and Quality Control Limits for Antifungal Disk Diffusion Susceptibility Testing of Yeasts
InVitro Diagnostics
2019-07-15
7-287
Complete
2009-08-31
Replaced
M45-Ed3
 
Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria
InVitro Diagnostics
2021-06-07
7-262
Partial
2015-10-02
Active
M47-A
 
Principles and Procedures for Blood Cultures
InVitro Diagnostics
2009-03-18
7-189
Complete
2007-05-24
Replaced
M48-Ed2
 
Laboratory Detection and Identification of Mycobacteria; Approved Guideline
InVitro Diagnostics
2019-01-14
7-285
Complete
2018-09-13
Active
M50-A
M50-P
Quality Control for Commercial Microbial Identification Systems
InVitro Diagnostics
2009-03-18
7-190
Complete
2008-08-29
Archived
M51-A
M51-P
Method for Antifungal Disk Diffusion Susceptibility Testing of Nondermatophyte Filamentous Fungi
InVitro Diagnostics
2013-08-06
7-243
Partial
2010-05-25
Archived
M52-Ed1
 
Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems
InVitro Diagnostics
2019-12-23
7-295
Complete
2015-08-25
Reaffirmed
M53-A
 
Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection
InVitro Diagnostics
2012-03-16
7-227
Complete
2011-06-30
Replaced
M56-A
 
Principles and Procedures for Detection of Anaerobes in Clinical Specimens
InVitro Diagnostics
2015-08-14
7-257
Complete
2014-07-30
Active
M58-Ed1
 
Methods for the Identification of Cultured Microorganisms Using Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry
InVitro Diagnostics
2017-08-21
7-273
Complete
2017-04-26
Active
M62- Ed1
M24-S
Performance Standards for Susceptibility Testing of Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes
InVitro Diagnostics
2021-06-07
7-292
Partial
2018-11-28
Replaced
M100-Ed33
M100-Ed-32
Performance Standards for Antimicrobial Susceptibility Testing
InVitro Diagnostics
2023-05-29
7-317
Partial
2023-03-03
Replaced
MM01-A3
MM01-A2
Molecular Methods for Clinical Genetics and Oncology Testing
InVitro Diagnostics
2013-01-15
7-237
Complete
2012-05-18
Replaced
MM03-Ed3
MM03-A2
Molecular Diagnostic Methods for Infectious Diseases
InVitro Diagnostics
2016-04-04
7-260
Complete
2015-02-27
Archived
MM05-A2
MM05-A
Nucleic Acid Amplification Assays for Molecular Hematopathology
InVitro Diagnostics
2019-01-14
7-232
Complete
2012-03-30
Archived
MM06-A2
MM06-A
Quantitative Molecular Methods for Infectious Diseases
InVitro Diagnostics
2013-01-15
7-238
Complete
2010-11-30
Reaffirmed
MM09-A2
MM09-A
Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine
InVitro Diagnostics
2015-08-14
7-255
Partial
2014-02-28
Replaced
MM13-Ed2
MM13-A
Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods
InVitro Diagnostics
2020-12-21
7-300
Complete
2020-08-25
Active
MM17-Ed2
 
Verification and Validation of Multiplex Nucleic Acid Assays
InVitro Diagnostics
2019-07-15
7-289
Partial
2018-05-31
Reaffirmed
MM18-A
 
Interpretive Criteria for Identification of Bacteria and Fungi by DNA Target Sequencing
InVitro Diagnostics
2009-03-18
7-192
Complete
2008-04-01
Replaced
MM21-Ed1
 
Genomic Copy Number Microarrays for Constitutional Genetic and Oncology Applications
InVitro Diagnostics
2016-06-27
7-264
Partial
2015-08-28
Reaffirmed
MM24-Ed1
 
Molecular Methods for Genotyping and Strain Typing of Infectious Organisms
InVitro Diagnostics
2024-05-29
7-321
Partial
2021-09-30
Active
MM23-Ed1
 
Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms)
InVitro Diagnostics
2019-01-14
7-269
Partial
2015-04-28
Active
NBS01-Ed7
 
Blood Collection on Filter Paper for Newborn Screening Programs
InVitro Diagnostics
2023-05-29
7-316
Complete
2021-04-16
Active
POCT01-A2
 
Point-of-Care Connectivity
Software/Informatics
2008-09-09
13-14
Complete
2006-07-28
Archived
POCT04-Ed3
 
Essential Tools for Implementation and Management of a Point-of-Care Testing Program
InVitro Diagnostics
2018-09-17
7-283
Complete
2016-06-30
Reaffirmed
POCT05-Ed2
POCT05-A
Performance Metrics for Continuous Interstitial Glucose Monitoring
InVitro Diagnostics
2021-06-07
7-307
Complete
2020-11-09
Active
POCT14-Ed2
POCT14-A
Point-of-Care Coagulation Testing and Anticoagulation Monitoring
InVitro Diagnostics
2020-12-21
7-299
Complete
2020-07-27
Active
QMS01-Ed5
QMS01-A4
A Quality Management System Model for Laboratory Services
InVitro Diagnostics
2019-12-23
7-293
Complete
2019-06-19
Active
QMS06-A3
GP22-A3
Quality Management System: Continual Improvement
InVitro Diagnostics
2014-01-30
7-223
Complete
2011-06-30
Reaffirmed
QMS24-Ed3
GP27-A2 and GP29-A2
Using Proficiency Testing and Alternative Assessment to Improve Medical Laboratory Quality
InVitro Diagnostics
2019-01-14
7-139
Complete
2016-09-29
Reaffirmed