| Device | CINtec PLUS Cytology |
|---|---|
| Generic Name | Immunocytochemistry assay, p16/Ki-67 |
| Applicant | Ventana Medical Systems, Inc. 1910 E Innovation Park Drive Tucson, AZ 85755 |
| PMA Number | P190024 |
| Supplement Number | S013 |
| Date Received | 12/30/2024 |
| Decision Date | 04/25/2025 |
| Product Code | QKF |
| Advisory Committee | Pathology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/Components/Specifications/Material |
| Expedited Review Granted? | No |
| Combination Product | No |
| Approval Order Statement Approval for migration of the CINtec PLUS Cytology assay to a new automated slide stainer instrument, BenchMark ULTRA PLUS. | |
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P190024/S013 review time is faster than 81.5% of similar devices* and 35.2% faster than the median.
* Similar Devices - Devices that share the same advisory committee and supplement type.
| Suppl. # | Suppl. Type & Reason | Approval Order Statement | Received | Decision |
|---|---|---|---|---|
| S012 | Real-Time Process Labeling Change - Indications/instructions/shelf Life/tradename |
Approval for a change in expiry dating (extension to the stability from 12 months to 18 months) for hematoxylin (pn 760-2021) and hematoxylin ii (pn 790-2208). |
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| S011 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Addition of an alternative supplier for dispenser component parts | ||
| S010 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Addition of two contract manufacturers as approved suppliers of parts/components. |
||
| S009 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Changes to a manufacturing process. | ||
| S008 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Changes to a manufacturing process. | ||
| S007 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Addition of alternative suppliers for component parts. | ||
| S006 | Special (Immediate Track) Labeling Change - Indications/instructions/shelf Life/tradename |
Approval for (i) a change in expiry dating from hematoxylin and hematoxylin ii and (ii) implementation of a revised process for creating reference slides used in surveillance and stability testing of hematoxylin and hematoxylin ii. |
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| S005 | 135 Review Track For 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Approval for the addition of two new contract manufacturers as approved suppliers for component parts. |
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| S004 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Modification of a method for preparing qualified samples used in qc testing. | ||
| S003 | Real-Time Process Change Design/Components/Sp - ecifications/Material |
Approval for the dispenser resin replacement used in the injection molding process for six (6) dispenser parts. |
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| S002 | Real-Time Process Change Design/Components/Sp - ecifications/Material |
Approval for the replacement of dispenser molds used in the injection molding process for six (6) dispenser parts. |
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| S001 | Normal 180 Day Track Labeling Change - Indications/instructions/shelf Life/tradename |
Approval for expanding the indications for use to add the cobas® 6800/8800 systems (cobas® hpv) test to identify hpv positive patients. |
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| Original | Original |
Approval for the cintec® plus cytology test. the device is a qualitative immunocytochemical assay intended for the simultaneous detection of the p16ink4a and ki-67 proteins in cervical specimens collected by a clinician using an endocervical brush/spatula or broom collection device and placed in the thinprep® pap test preservcyt® solution. the cintec plus cytology test includes a ready-to-use cocktail of primary antibodies which contains a mouse monoclonal antibody directed against human p16ink4a (p16) protein (clone e6h4), and a recombinant rabbit monoclonal antibody directed against human ki-67 protein (clone 274-11ac3v1) for use on the benchmark ultra instrument with 3,3-diaminobenzidine tetrahydrochloride (dab) and fast red detection systems.the cintec plus cytology test is indicated:1) to be used in women 25 - 65 years old with 12 other high risk (hr) hpv positive test results using the cobas® 4800 hpv test in primary hpv screening, to determine the need for referral to colposcopy.to be used in women 25 - 65 years old with hpv16/18 positive test results using the cobas® 4800 hpv test in primary hpv screening where the cintec plus cytology test results will be used in conjunction with the physicians assessment of patient screening history, other risk factors, and professional guidelines to guide patient management.2) to be used in women 30 - 65 years old with nilm (negative for intraepithelial lesion or malignancy) and 12 other hr hpv positive test results using the cobas 4800 hpv test in adjunctive cervical cytology and hr hpv screening, to determine the need for referral to colposcopy.to be used in women 30 - 65 years old with nilm (negative for intraepithelial lesion or malignancy) and hpv16/18 positive test results using the cobas® 4800 hpv test in adjunctive cervical cytology and hr hpv screening where the cintec plus cytology test results will be used in conjunction with the physicians assessment of patient screening history, other risk factors, and professional guidelines to guide patient management.results from the cintec plus cytology test should be interpreted by a qualified pathologist. |
