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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceAPTIMA HPV ASSAY
Generic NameKit, rna detection, human papillomavirus
ApplicantGEN-PROBE INCORPORATED
10210 Genetic Center Drive
San Diego, CA 92121
PMA NumberP100042
Supplement NumberS001
Date Received10/04/2012
Decision Date07/15/2013
Product Code OYB 
Advisory Committee Microbiology
Clinical TrialsNCT01446198
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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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