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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 031 FR Publication Date: 08/05/2013 

Part B: Supplementary Information

Recognition Number 7-242: CLSI C56-A, hemolysis, icterus, and lipemia/turbidity indices as indicators of interference in clinical laboratory analysis; approved guideline. (InVitro Diagnostics)

Date of Standard: 2012. 
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)
Devices Affected:
Any automated clinical laboratory instrument intended to measure analytes in human serum or plasma for clinical laboratory testing
Processes Affected:
510(k), PMA, IDE, HDE
Type of Standard:
 Horizontal, National
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§862.2160 Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Class 1 JJE
Relevant Guidance:
CLSI EP07-A2, Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition (2005)
FDA Technical Contact:
 Yung Chan
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room 5630
  Silver Spring MD 20993
  301/796-6138
  email: yung.chan@fda.hhs.gov
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