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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 027 Date of Entry 08/02/2011 
FR Recognition Number 7-219
Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guidelines-Second Edition.
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
 Shyam Kalavar
 Gene Pennello
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.