Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

020

Date of Entry 09/09/2008 

FR Recognition Number

13-12

Standard

CLSI  AUTO4-A
Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard

Scope/Abstract

This document describes operational requirements, characteristics, and required information elements of clinical laboratory automation systems. This information is used to determine the status of a clinical specimen within the clinical laboratory automation system, as well as the status of the actual components of the clinical laboratory automation system.

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

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.