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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 16 18/45 GENOTYPE ASSAY
Generic Namekit, rna detection, human papillomavirus
ApplicantGEN-PROBE INCORPORATED
10210 genetic center drive
san diego, CA 92121
PMA NumberP120007
Supplement NumberS001
Date Received05/15/2013
Decision Date11/06/2013
Product Code OYB 
Advisory Committee Microbiology
Clinical TrialsNCT01694875
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF THE PANTHER SYSTEM TO THE APTIMA® HPV 16 18/45 GENOTYPE ASSAY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME APTIMA® HPV 16 18/45 GENOTYPE ASSAY. THE APTIMA HPV 16 18/45 GENOTYPE ASSAY IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE QUALITATIVE DETECTION OF E6/E7 VIRAL MESSENGER RNA (MRNA) OF HUMAN PAPILLOMAVIRUS (HPV) TYPES 16, 18, AND 45 IN CERVICAL SPECIMENS FROM WOMEN WITH APTIMA HPV ASSAY POSITIVE RESULTS. THE APTIMA HPV 16 18/45 GENOTYPE ASSAY CAN DIFFERENTIATE HPV 16 FROM HPV 18 AND/OR HPV 45, BUT DOES NOT DIFFERENTIATE BETWEEN HPV 18 AND HPV 45. CERVICAL SPECIMENS IN THINPREP PAP TEST VIALS CONTAINING PRESERVCYT SOLUTION AND COLLECTED WITH BROOM-TYPE OR CYTOBRUSH/SPATULA COLLECTION DEVICES* MAY BE TESTED WITH THE APTIMA HPV 16 18/45 GENOTYPE ASSAY. THE ASSAY IS USED WITH THE TIGRIS DTS SYSTEM OR THE PANTHER SYSTEM. FOR FURTHER INFORMATION PLEASE REFER TO THE APPROVAL ORDER.
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