Cervical Intraepithelial Neoplasia (Cin) Test System
The Cervical Intraepithelial Neoplasia (CIN) Test System is a qualitative immunohistochemistry (IHC) test that assesses p16INK4a protein in formalin-fixed, paraffin-embedded (FFPE) cervical punch biopsy tissues as an adjunct to H&E staining, intended to improve consistency in the diagnosis of cervical intraepithelial neoplasia. It is classified as FDA Class 2 under 21 CFR 864.1865 in the Pathology specialty, requiring 510(k) premarket notification. Diagnosis must be based on H&E-stained slides and other clinical and laboratory information. Product code PRB; not an implant and not life-sustaining.
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Basic Information
- Product Code
- PRB
- Device Class
- FDA class 2
- Regulation Number
- 864.1865
- Medical Specialty
- Pathology
- Review Panel
- PA
- Submission Type
- 1
Device Characteristics
Definition
The p16 CIN test system is a qualitative immunohistochemistry (IHC) test to assess the p16INK4a protein in formalin-fixed, paraffin-embedded (FFPE) cervical punch biopsy tissues. It is indicated as an adjunct to examination of hematoxylin and eosin (H&E) stained slide(s), to improve consistency in the diagnosis of CIN. Diagnosis of CIN presence or level should be based on H&E stained slide(s) and other clinical and laboratory test information.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.