Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

028

Date of Entry 03/16/2012 

FR Recognition Number

7-166

Standard

CLSI  GP20-A2 (Replaces GP20-A)
Fine Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline - Second Edition

Scope/Abstract

This document contains recommended procedures for performing fine needle aspiration biopsies of superficial (palpable) and deep-seated (nonpalpable) lesions/masses, from patient preparation through staining the smear.

Extent of Recognition

Complete standard

Public Law, CFR Citation(s) and Procode(s)*

Regulation Number	Device Name	Device Class	Product Code
§864.1850	Stain, Ponceau	Class 1	HZO
§864.3010	Microtome, Accessories	Class 1	IDL
§864.3010	Microtome, Rotary	Class 1	IDO
§864.3010	Cassettes, Tissue	Class 1	IDZ
§864.3010	Slides, Microscope	Class 1	KEW
§864.3300	Cytocentrifuge	Class 1	IFB
§864.3600	Light, Microscope	Class 1	IBJ
§864.3800	Stainer, Tissue, Automated	Class 1	KEY

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 Contact

 Shyam Kalavar

  FDA/OC/CDRH/OPEQ/OIDRH/DMGP/MPCB/

  301-796-6807

  shyam.kalavar@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.