Recognition List Number: 027 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 Organization: |
| Clinical Laboratory Standards Institute (CLSI) |
| 950 West Valley Road |
| Suite 2500 |
| Wayne, PA 19087 |
| |
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| CDRH Offices and Divisions Associated with Recognized Standards: |
| (1) | OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR) |
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| (2) | OFFICE OF SURVEILLANCE AND BIOMETRICS (OSB) |
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| 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) |
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| Type of Standard: |
| Vertical, National |
| Extent of Recognition: |
| Complete standard and any annexes. |
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| 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 |
| |
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| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
|
| FDA Technical Contact: |
| Max Robinowitz, MD |
| FDA/CDRH/OIVD |
| 10903 New Hampshire Avenue Building 66, Room 5536 |
| Silver Spring MD 20993 |
| 301/796-6182 |
| Email: max.robinowitz@fda.hhs.gov |
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