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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 020 FR Publication Date: 09/09/2008 

Part B: Supplementary Information

Recognition Number 7-136: CLSI I/LA2-A2, quality assurance of laboratory tests for autoantibodies to nuclear antigens: (1) indirect flurescence assay for microscopy and (2) microtiter enzyme immunoassay methods; approved guideline - second edition. (InVitro Diagnostics)

Date of Standard: 2006. 
Address of Standards Development Organization:
 Clinical Laboratory Standards Institute (CLSI)
  950 West Valley Road
  Suite 2500
  Wayne, PA 19087
 
CDRH Office and Division associated with recognized standards:
OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
DIVISION OF IMMUNOLOGY AND HEMATOLOGY DEVICES (DIHD)
Devices Affected:
Devices to test for autoantibodies to nuclear antigen (ANA)
Processes Affected:
510(K), PMA, PDP, IDE, HDE
Type of Standard:
 National, Vertical
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§866.5100 Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls Class 2 LJM
§866.5100 Antinuclear Antibody, Antigen, Control Class 2 LKJ
§866.5100 Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control Class 2 DHN
§866.5100 Extractable Antinuclear Antibody, Antigen And Control Class 2 LLL
Relevant Guidance:
Review Criteria for the the Assessment of Anti-Nuclear Antiboy Test Systems; Guidance for Industry and FDA
FDA Technical Contact:
 Elizabeth Stafford
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room 5608
  Silver Spring MD 20993
  301/796-6184
  email: elizabeth.stafford@fda.hhs.gov
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