Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

027

Date of Entry 08/02/2011

FR Recognition Number

7-219

Standard

CLSI I/LA28-A2
Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guidelines-Second Edition.

Scope/Abstract

This guideline focuses on validation of immunohistochemistry assays on formalin-fixed, paraffin-embedded pathology material. The audience for this guideline includes the assay developer, the reagent supplier, laboratory histotechnologist who performs the assay, and the laboratory director/pathologist who implements and interprets the assay.

Extent of Recognition

Complete standard

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

Regulation Number	Device Name	Device Class	Product Code
§864.1860	Immunohistochemistry Assay, Antibody, Progesterone Receptor	Class 2	MXZ
§864.1860	Immunohistochemistry Antibody Assay, Estrogen Receptor	Class 2	MYA
§864.1860	Immunohistochemistry Reagents And Kits	Class 1	NJT
§864.1860	Control Material, Her-2/Neu, Immunohistochemistry	Class 2	NJW
§864.1860	Immunohistochemistry Antibody Assay, C-Kit	Class 3	NKF
§864.1860	Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor	Class 3	NQF
§864.1860	Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity	Class 2	NQN

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

Gene Pennello

FDA/OC/CDRH/OSEL/DIDSR/

301-796-6038

gene.pennello@fda.hhs.gov

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