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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 031 Date of Entry 08/06/2013 
FR Recognition Number 7-242
Standard
CLSI  C56-A
Hemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of Interference in Clinical Laboratory Analysis; Approved Guideline
Scope/Abstract
This document focuses on the intended usefulness and challenging issues of hemolysis, icterus, and lipemia/turbidity (HIL) indices as estimates of interference that may impact the validity and clinical utility of reportable patient results. C56 is closely aligned with CLSI document EP07; thus, the basic concepts for interference testing are briefly discussed in C56 to gain an understanding of the process by which HIL alert indices are established. Automated HIL systems currently available from various manufacturers are also described. This document enhances the continuous education of health care personnel by explaining the mechanisms of HIL interference, which in some cases include the noncorrelation of visual and (semi)quantitative HIL indices, the strengths and limitations of HIL measurements, and the verification of HIL indices in the clinical laboratory.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§862.2160 Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Class 1 JJE
Relevant FDA Guidance and/or Supportive Publications*
CLSI EP07-A2 Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition.

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
 Yung Chan
  FDA/OC/CDRH/OPEQ/OIDRH/DCTD/
  301-796-6138
  yung.chan@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.
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