FDA product code PRB: Cervical Intraepithelial Neoplasia (Cin) Test System
PRB is the FDA product code for cervical intraepithelial neoplasia (cin) test system. It is a Class II device, regulated under 21 CFR 864.1865 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under PRB. The average 510(k) review took 151 days (median 151). 1 De Novo request was granted under it. FDA has posted 3 recalls for PRB devices.
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.
Classification
| Field | Value |
|---|---|
| Device name | Cervical Intraepithelial Neoplasia (Cin) Test System |
| Device class | Class II |
| Regulation | 21 CFR 864.1865 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) |
510(k) clearances per year for PRB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 151 |
Compare with all 510(k) review times · Search every PRB clearance
Top PRB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ventana Medical Systems, Inc. | 1 | 2021-12-10 |
Most recent PRB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K212176 | Ventana Medical Systems, Inc. | CINtec Histology | 2021-12-10 | 151 |
Recalls for PRB devices
3 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-08-02.
| Year | Recalls |
|---|---|
| 2018 | 3 |
Frequently asked questions
What is FDA product code PRB?
PRB is the FDA product code for cervical intraepithelial neoplasia (cin) test system. It is a Class II device, regulated under 21 CFR 864.1865 and reviewed by the Pathology panel.
What device class is PRB?
Class II, regulation 21 CFR 864.1865. Typical premarket route: 510(k).
How long does a 510(k) take for product code PRB?
Across 1 cleared submissions the average was 151 days from receipt to decision (median 151).
Which companies have the most PRB clearances?
Ventana Medical Systems, Inc. (1).
Have PRB devices been recalled?
Yes: 3 product recalls across 1 recall events; the most recent began 2018-08-02.
Next steps
- Run an FDA pathway report with predicate devices for product code PRB
- Run a recall and safety report across every PRB manufacturer
- Watch product code PRB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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