Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | APTIMA HPV ASSAY |
Generic Name | Kit, rna detection, human papillomavirus |
Applicant | GEN-PROBE INCORPORATED 10210 Genetic Center Drive San Diego, CA 92121 |
PMA Number | P100042 |
Supplement Number | S001 |
Date Received | 10/04/2012 |
Decision Date | 07/15/2013 |
Product Code |
OYB |
Advisory Committee |
Microbiology |
Clinical Trials | NCT01446198
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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 THE ADDITION OF THE PANTHER SYSTEM TO THE APTIMA® HPV ASSAY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME APTIMA® HPV ASSAY. THE APTIMA HPV ASSAY IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE QUALITATIVE DETECTION OF E6/E7 VIRAL MESSENGER RNA (MRNA) FROM 14 HIGH-RISK TYPES OF HUMAN PAPILLOMAVIRUS (HPV) IN CERVICAL SPECIMENS. THE HIGH-RISK HPV TYPES DETECTED BY THE ASSAY INCLUDE: 16, 18, 31, 33, 35, 39, 45, 51, 52,56, 58, 59, 66, AND 68. THE APTIMA HPV ASSAY DOES NOT DISCRIMINATE BETWEEN THE 14 HIGH-RISK TYPES. CERVICAL SPECIMENS COLLECTED IN THINPREP PAP TEST VIALS CONTAINING PRESESRVCYT SOLUTION AND COLLECTED WITH BROOM-TYPE OR CYTOBRUSH/SPATULA COLLECTION DEVICES* MAY BE TESTED WITH THE APTIMA HPV ASSAY. THE ASSAY IS USED WITH THE TIGRIS DTS SYSTEM OR THE PANTHER SYSTEM. THE USE OF THE TEST IS INDICATED: 1) TO SCREEN WOMEN 21 YEARS AND OLDER WITH ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE (ASC-US) CERVICAL CYTOLOGY RESULTS TO DETERMINE THE NEED FOR REFERRAL TO COLPOSCOPY. THE RESULTS OF THIS TEST ARE NOT INTENDED TO PREVENT WOMEN FROM PROCEEDING TO COLPOSCOPY; AND 2) IN WOMEN 30 YEARS AND OLDER, THE APTIMA HPV ASSAY CAN BE USED WITH CERVICAL CYTOLOGY TO ADJUNCTIVELY SCREEN TO ASSESS THE PRESENCE OR ABSENCE OF HIGH-RISK HPV TYPES. THIS INFORMATION, TOGETHER WITH THE PHYSICIANS ASSESSMENT OF CYTOLOGY HISTORY, OTHER RISK FACTORS, AND PROFESSIONAL GUIDELINES, MAY BE USED TO GUIDE PATIENT MANAGEMENT. BROOM-TYPE DEVICE (E.G., WALLACH PIPETTE) OR ENDOCERVICAL BRUSH/SPATULA. |
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