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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 029 Date of Entry 08/20/2012 
FR Recognition Number 7-197
Standard
CLSI  M35-A2 (Replaces M35-A)
Abbreviated Identification of Bacteria and Yeast; Approved Guideline - Second Edition.
Scope/Abstract
This standard includes the minimum identification criteria that can be used to rapidly identify a limited number of organisms commonly isolated from patient specimens. Although these tests do not rule out an occasional misidentification, those errors may not have important consequences with regard to patient outcome. Those situations in which rapid test results may have limitations are described. Unless those exceptions provide clinically useful information, confirmatory identification need not be done.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§866.2660 Kit, Anaerobic Identification Class 1 JSP
§866.2660 Discs, Strips And Reagents, Microorganism Differentiation Class 1 JTO
§866.2660 Kit, Screening, Yeast Class 1 JXC
§866.2660 Gram Negative Identification Panel Class 1 LQM
§866.2660 Instrument For Auto Reader Of Overnight Microorganism Identification System Class 1 LRH
§866.3310 Hepatitis A Test (Antibody And Igm Antibody) Class 2 LOL
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems, Issued August 2009.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Hannah Livesay
  CDRH/OPEQ/OHTVII/DMD/BAC1
  --
  hannah.livesay@fda.hhs.gov
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
InVitro Diagnostics
*These are provided as examples and others may be applicable.
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