CINtec PLUS Cytology

FDA Premarket Approval P190024

Pre-market Approval Supplement Details

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.

DeviceCINtec PLUS Cytology
Generic NameImmunocytochemistry Assay, P16/ki-67
ApplicantVentana Medical Systems, Inc.
Date Received2019-09-12
Decision Date2020-03-10
PMAP190024
SupplementS
Product CodeQKF 
Advisory CommitteePathology
Expedited ReviewNo
Combination Product No
Applicant Address Ventana Medical Systems, Inc. 1910 E Innovation Park Drive tucson, AZ 85755
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

Supplemental Filings

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Supplement NumberDateSupplement Type
P190024Original Filing

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