Identity
- Trade Name
- CINtec PLUS Cytology FDA PMA
- Generic Name
- Immunocytochemistry assay, p16/Ki-67 FDA PMA
Identifiers
- PMA Number
- P190024 FDA PMA
- FDA Product Code
- QKF FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Legislation / Framework
- 21 CFR Part 864.1860 FDA PMA
- Regulation Number
- 864.1860 FDA PMA
- Advisory Committee
- Pathology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The CINtec Plus Cytology is a qualitative immunocytochemical assay classified as an immunocytochemistry assay for p16INK4a and Ki-67 proteins. It is designed for the simultaneous detection of these biomarkers in cervical specimens collected via endocervical brush, spatula, or broom and preserved in ThinPrep Pap Test PreservCyt Solution. The assay employs a ready-to-use antibody cocktail for use on the BenchMark ULTRA instrument with DAB and Fast Red detection systems.
This device is intended for use in conjunction with the cobas 4800 HPV Test in primary HPV screening or adjunctive cervical cytology and HR HPV screening. It aids in determining referral to colposcopy for women aged 25–65 with high-risk HPV results or HPV16/18 positivity, with results interpreted by a qualified pathologist. Supplied as a single-use diagnostic test, it requires laboratory processing and is approved under FDA PMA (P190024).
Frequently asked questions
What types of cervical specimens can be tested with the CINtec PLUS Cytology, and how should they be collected and preserved?
The CINtec PLUS Cytology is designed for cervical specimens collected using an endocervical brush, spatula, or broom. These specimens must be preserved in ThinPrep Pap Test PreservCyt Solution to ensure compatibility with the assay. The test relies on these preserved samples to detect p16INK4a and Ki-67 biomarkers for further evaluation.
How is the CINtec PLUS Cytology assay performed in the laboratory, and what equipment is required?
The CINtec PLUS Cytology uses a ready-to-use antibody cocktail for simultaneous detection of p16INK4a and Ki-67 proteins. It is processed on the BenchMark ULTRA instrument with DAB (3,3-diaminobenzidine tetrahydrochloride) and Fast Red detection systems. This means the test requires specialized laboratory equipment and trained personnel to run the assay.
Who should interpret the results of the CINtec PLUS Cytology test, and what role does it play in patient management?
Results from the CINtec PLUS Cytology must be interpreted by a qualified pathologist. It aids in determining whether women aged 25–65 with high-risk HPV results (including HPV16/18) or HPV-positive cytology results should be referred for colposcopy, helping guide clinical decision-making alongside other patient factors and guidelines.
Is the CINtec PLUS Cytology test intended for single-use, and how should it be stored?
Yes, the CINtec PLUS Cytology is supplied as a single-use diagnostic test. While storage instructions are not explicitly detailed in the provided data, single-use assays like this typically require refrigeration or following the manufacturer’s guidelines to maintain stability until use. Always refer to the included packaging or manufacturer’s instructions for precise storage conditions.
What is the intended clinical use of the CINtec PLUS Cytology when combined with the cobas 4800 HPV Test?
The CINtec PLUS Cytology is intended for use alongside the cobas 4800 HPV Test in two scenarios: (1) as an adjunct in primary HPV screening for women aged 25–65 with high-risk HPV results to help determine colposcopy referral, and (2) in adjunctive cervical cytology and HR HPV screening for women aged 30–65 with negative cytology but positive HPV results. It is not intended to replace clinical judgment but rather to assist in risk stratification.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P190024 | Class III | Active |
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Manufacturer
- Manufacturer
- Ventana Medical Systems, Inc.
Sources (1)
- FDA PMA P190024 24 fields · synced Oct 6, 2026