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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 050 Date of Recognition 09/17/2018 
FR Recognition Number 7-284
Standard
CLSI EP37 1st Edition
Supplemental Tables for Interference Testing in Clinical Chemistry
Scope/Abstract
The supplemental tables presented in EP37 are intended for use with the evaluation procedures presented in CLSI document EP07. The supplemental table in EP37 provide recommended test concentrations for analytes and endogenous substances that may interfere in measurement procedures.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§862.1345 System, Test, Blood Glucose, Over The Counter Class 2 NBW
Regulation Number Device Name Device Class Product Code
§862.1345 Glucose Dehydrogenase, Glucose Class 2 LFR
Regulation Number Device Name Device Class Product Code
§862.1345 Hexokinase, Glucose Class 2 CFR
Regulation Number Device Name Device Class Product Code
§862.1345 Glucose Oxidase, Glucose Class 2 CGA
Regulation Number Device Name Device Class Product Code
§862.1345 Prescription Use Blood Glucose Meter For Near-Patient Testing Class 2 PZI
FDA Technical Contacts
 Francisca Reyes Turcu
  OMPT/CDRH/OIR/DMGP/MPCB
  301-348-1971
  Francisca.ReyesTurcu@fda.hhs.gov
 Leslie Landree
  FDA/OMPT/CDRH/OIR/DCTD/DDDB/
  301-796-6147
  leslie.landree@fda.hhs.gov
 Douglas Rheinheimer
  FDA/OMPT/CDRH/OIR/DCTD/CTXB/
  301-796-6157
  douglas.rheinheimer@fda.hhs.gov
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
InVitro Diagnostics
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