Recognized Consensus Standards: Medical Devices

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