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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 028 Date of Entry 03/16/2012 
FR Recognition Number 7-166
CLSI  GP20-A2 (Replaces GP20-A)
Fine Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline - Second Edition
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
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.