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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 021 Date of Entry 03/18/2009 
FR Recognition Number 13-26
Standard
CLSI  AUTO10-A
Autoverification of Clinical Laboratory Test Results; Approved Guideline
Scope/Abstract
This document provides a general framework that will allow each laboratory to easily design, implement, validate, and customize rules for autoverification (automated verification) based on the needs of its own patient population.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§862.2100 Calculator/Data Processing Module, For Clinical Use Class 1 JQP
Automated instrumentation under: Part 862 Clinical Chemistry and Clinical Toxicology Devices Part 864 Hematology and Pathology Devices Part 866 Immunology and Microbiological 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
 Yan Zhang
  CDRH/OPEQ/OHTVII/DMGP/MGB/
  301-837-7386
  yan.zhang1@fda.hhs.gov
 Thomas Miller
  CDRH/OPEQ/OHTVII/DCTD/CB/
  240-402-8938
  Thomas.Miller@fda.hhs.gov
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
Software/Informatics
*These are provided as examples and others may be applicable.
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