Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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029
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Date of Entry 08/20/2012
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FR Recognition Number
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7-197
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Standard | |
CLSI M35-A2 (Replaces M35-A) Abbreviated Identification of Bacteria and Yeast; Approved Guideline - Second Edition. |
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Scope/AbstractThis 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. |
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Extent of Recognition
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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
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JTO
|
§866.2660 |
Kit, Screening, Yeast
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Class 1
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JXC
|
§866.2660 |
Gram Negative Identification Panel
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Class 1
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LQM
|
§866.2660 |
Instrument For Auto Reader Of Overnight Microorganism Identification System
|
Class 1
|
LRH
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§866.3310 |
Hepatitis A Test (Antibody And Igm Antibody)
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Class 2
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LOL
|
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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. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |