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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Recognition List Number: 020 Publication Date: 09/09/2008 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 7-41: NCCLS I/LA19-A, Primary Reference Preparations Used to Standardize Calibration of Immunochemical Assays for Serum Prostate Specific Antigen (PSA); Approved Guideline (1997). (InVitro Diagnostics)

Date of Standard: 1997. 
Address of Standards Organization:
  National Committee for Clinical Laboratory Standards (NCCLS)
  950 West Valley Road
  Suite 2500
  Wayne, PA 19087
 
CDRH Office and Division Associated with Recognized Standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Primary Reference Preparations Used to Standardize Calibration of Immunochemical Assays for Serum Prostate Specific Antigen (PSA)
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
§866.6010 Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers Class 2 LTJ
 
Relevant Guidance:
Guidance for Submission of Tumor Marker Premarket Notifiction 510(k), PMA, PDP, IDE, HDE to FDA

Points to Consider for Collection of Data in Support of In Vitro Device Submissions for 510(k) Clearance
FDA Technical Contact:
  Dai Li
  FDA/CDRH/OIVD
  2098 Gaither Road, HFZ-440
  Rockville MD 20850
  240/276-0997
  Email: dai.li@fda.hhs.gov
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