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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 027 FR Publication Date: 08/02/2011 

Part B: Supplementary Information

Recognition Number 7-219: CLSI I/LA28-A2, quality assurance for design control and implementation of immunohistochemistry assays; approved guidelines-second edition. (InVitro Diagnostics)

Date of Standard: 2011. 
Address of Standards Development Organization:
 Clinical Laboratory Standards Institute (CLSI)
  950 West Valley Road
  Suite 2500
  Wayne, PA 19087
 
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
(2)OFFICE OF SURVEILLANCE AND BIOMETRICS (OSB)
Devices Affected:
Immunohistochemistry and immunocytochemistry in vitro diagnostic devices. Appendix A discusses statistical procedures for these devices and other qualitative and semi-quantitative IVDs including devices that report ordinal data.
Processes Affected:
Total test model for immunohistochemistry IVDs (total product life cycle)
Type of Standard:
 National, Vertical
Extent of Recognition:
Complete standard and any annexes.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§864.1860 Control Material, Her-2/Neu, Immunohistochemistry Class 2 NJW
§864.1860 Immunohistochemistry Antibody Assay, C-Kit Class 3 NKF
§864.1860 Immunohistochemistry Antibody Assay, Estrogen Receptor Class 2 MYA
§864.1860 Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor Class 3 NQF
§864.1860 Immunohistochemistry Assay,Antibody,Progesterone Receptor Class 2 MXZ
§864.1860 Immunohistochemistry Reagents And Kits Class 1 NJT
§864.1860 Microscope,Automated,Image Analysis,Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity Class 2 NQN
FDA Technical Contact:
 Gene Pennello, PhD
  FDA/CDRH/OSB
  10903 New Hampshire Avenue Building 66, Room 2118
  Silver Spring MD 20993
  301/796-6038
  email: gene.pennello@fda.hhs.gov
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