Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 028 Date of Entry 03/16/2012 
FR Recognition Number 7-227
Standard
CLSI  M53-A (Replaces M53-P)
Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection; Approved Guideline
Scope/Abstract
This document provides an extensive review of existing laboratory methods commonly used to test for HIV infection. This guideline also offers recommendations for how to best use and interpret these tests accurately and effectively to diagnose HIV infection.
Extent of Recognition
Complete standard
Relevant FDA Guidance and/or Supportive Publications*
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
 Pradip Akolkar
  FDA/OC/CBER/OBRR/DETTD/PRB/
  301-827-5128
  pradip.akolkar@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.
-
-