510(k) · Cleared
ClearedCINtec Histology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ventana Medical Systems, Inc. · PRB Cervical Intraepithelial Neoplasia (Cin) Test System
Cleared on Dec 10, 2021 as substantially equivalent to DEN160019 (Ventana Medical Systems, Inc., 2017) after a 151-day review. Its family tree reaches back 1 generation to 2017.
- Decided
- Dec 10, 2021
- Review
- 151 days
- Class
- Class II
- Product code
- PRB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN160019 (2017). No later device cites it as a predicate yet.
- Root · 1 generation backDEN160019 CINtec Histology (50 tests), CINtec Histology (250 tests)Ventana Medical Systems, Inc. · 2017
- This deviceK212176 CINtec HistologyVentana Medical Systems, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN160019 | CINtec Histology (50 tests), CINtec Histology (250 tests) | Ventana Medical Systems, Inc. | 2017 | — |
| 0 (this device) | K212176 | CINtec Histology | Ventana Medical Systems, Inc. | 2021 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PRB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN160019 | CINtec Histology (50 tests), CINtec Histology (250 tests)Summary page 4…ation Name A cervical intraepithelial neoplasia (CIN) test system Product Codes PRB, 21 CFR 864.1865 Predicate Devices CINtec® Histology (DEN160019) Establishment Ventana Medical Systems, Inc., 2028492 Registration… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All PRB devicesPRB Cervical Intraepithelial Neoplasia (Cin) Test System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · PRB
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · PRB
Too few PRB 510(k)s in any year since 2007 to give a median.
Recalls per year · PRB
No recall names PRB since 2007.
Adverse event reports per year · PRB
No MAUDE report names PRB since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
CINtec® Histology is a qualitative immunohistochemistry (IHC) test using mouse monoclonal anti-p16 antibody clone E6H4, and is intended for use in the light microscopic assessment of the p16INK4a protein in formalin-fixed, paraffin-embedded (FFPE) cervical punch biopsy tissues using OptiView DAB IHC Detection Kit on a VENTANA BenchMark ULTRA instrument. The test is indicated as an adjunct to examination of hematoxylin and eosin (H&E) stained slide(s), to…
Read the full statement (103 words)
CINtec® Histology is a qualitative immunohistochemistry (IHC) test using mouse monoclonal anti-p16 antibody clone E6H4, and is intended for use in the light microscopic assessment of the p16INK4a protein in formalin-fixed, paraffin-embedded (FFPE) cervical punch biopsy tissues using OptiView DAB IHC Detection Kit on a VENTANA BenchMark ULTRA instrument. The test is indicated as an adjunct to examination of hematoxylin and eosin (H&E) stained slide(s), to improve consistency in the diagnosis of cervical intraepithelial neoplasia (CIN). Diagnosis of CIN presence or level should be based on H&E stained slide(s) and other clinical and laboratory test information.
Intended for in vitro diagnostic (IVD) use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K212176 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212176: CINtec Histology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212176
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026