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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 040 Date of Entry 08/14/2015 
FR Recognition Number 7-257
Principles and procedures for Detection of Anaerobes in Clinical Specimens; Approved Guideline
This document provides procedures for performing testing and providing accurate, reliable, and useful results to laboratories with differing levels of expertise in anaerobe bacteriology. Preexamination requirements for specimen selection, collection, transport, timely processing, and examination procedures are discussed. Rapid and complex methods are compared for their ability to provide definitive identifications. Because the delivery of preliminary reports is vital to patient care when complex final reports are delayed, interpretations of direct smears and culture results are presented to help laboratorians confidently issue preliminary reports. Descriptions of anaerobes involved in human disease and a discussion of diagnostic methods for Clostridium difficile disease are presented. Guidelines for establishing competency testing to laboratories at their various levels of expertise and complexity are included. Because failures in good practices for preexamination, examination, and postexamination techniques can put patients at risk, a discussion of risk assessment during the design and implementation of anaerobe bacteriology protocols is included.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§866.2120 Anaerobic Box Glove Class 1 JTM
§866.2390 Culture Media, Anaerobic Transport Class 1 JSL
§866.2660 Kit, Anaerobic Identification Class 1 JSP
§866.2660 Discs, Strips And Reagents, Microorganism Differentiation Class 1 JTO
§866.2660 Device, General Purpose, Microbiology, Diagnostic Class 1 LIB
§866.2660 Reagents, Clostridium Difficile Toxin Class 1 LLH
§866.2660 Antigen, C. Difficile Class 1 MCB
§866.2660 C. Difficile Nucleic Acid Amplification Test Assay Class 1 OMN
FDA Technical Contact
 Ribhi Shawar
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.