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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 023 Date of Entry 05/05/2010 
FR Recognition Number 7-207
Standard
CLSI  GP16-A3 (Replaces GP16-A2)
Urinalysis; Approved Guideline - Third Edition
Scope/Abstract
This document addresses procedures for testing urine, including materials and equipment; macroscopic/physical evaluation; chemical analysis; and microscopic analysis.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
21 CFR 862 CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
21 CFR 864 HEMATOLOGY AND PATHOLOGY DEVICES
21 CFR 866 IMMUNOLOGY AND MICROBIOLOGY DEVICES
Relevant FDA Guidance and/or Supportive Publications*
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 Contacts
 Tamara Pinkney
  FDA/OC/CDRH/OPEQ/OIDRH/DPOM/
  301-796-6182
  tamara.pinkney@fda.hhs.gov
 Sharmila Shrestha
  FDA/OC/CBER/OBRR/DBCD/DRB/
  240-402-6065
  Sharmila.Shrestha@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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