# Cervical Intraepithelial Neoplasia (Cin) Test System
> **Product code: PRB** · Class II — Moderate Risk (510(k) clearance required) · Pathology · 21 CFR 864.1865
## Classification
- **FDA Product Code:** PRB
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 864.1865
- **Review panel:** PA
- **Medical specialty:** Pathology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 2
- **Registered establishments:** 1
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PRB)
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