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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceCINtec PLUS Cytology
Generic Nameimmunocytochemistry assay, p16/ki-67
Applicant
Ventana Medical Systems, Inc.
1910 e innovation park drive
tucson, AZ 85755
PMA NumberP190024
Date Received09/12/2019
Decision Date03/10/2020
Product Code QKF 
Docket Number 20M-1083
Notice Date 03/16/2020
Advisory Committee Pathology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
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.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements:  S004 S001 S002 
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