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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Recognition List Number: 023 Publication Date: 05/05/2010 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 7-37: NCCLS I/LA6-A, Detection and Quantitation of Rubella IgG Antibody: Evaluation and Performance Criteria for Multiple Component Test Products, Specimen Handling, and Use of Test Products in the Clinical Laboratory; Approved Guideline. (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:
Rubella IgG antibody testing devices
Processes Affected:
510(k)
Type of Standard:
 National, Vertical
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number		 Device Name Device
Class		 Product
Code
§866.3510 Antisera, Cf, Rubella Class 2 GOM
§866.3510 Enzyme Linked Immunoabsorbent Assay, Rubella Class 2 LFX
§866.3510 Latex Agglutination Assay, Rubella Class 2 LQN
 
Relevant Guidance:
Points to Consider for Collection of Data in Support of In Vitro Device Submissions for 510(k) Clearance
FDA Technical Contact:
  Kathleen Whitaker
  FDA/CDRH/OIVD
  2098 Gaither Road, HFZ-440
  Rockville MD 20850
  240/276-0723 ext: 123
  Email: kathleen.whitaker@fda.hhs.gov
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