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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.
 
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
Date Received04/19/2012
Decision Date10/12/2012
Product Code OYB 
Docket Number 12M-1066
Notice Date 11/01/2012
Advisory Committee Microbiology
Clinical TrialsNCT01384370
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE APTIMA HPV 16 18/45 GENOTYPE ASSAY.APTIMA HPV 16 18/45 GENOTYPE ASSAY INDICATIONS FOR USE: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 POSITIVERESULTS. 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 ORCYTOBRUSH/SPATULA COLLECTION DEVICES* MAY BE TESTED WITH THE APTIMA HPV 16 18/45 GENOTYPE ASSAY. THE ASSAY IS USED WITH THE TIGRIS DTS SYSTEM. THE USE OF THE TEST IS INDICATED: 1) IN PATIENTS 21 YEARS AND OLDER WITH ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE(ASC-US) CERVICAL CYTOLOGY RESULTS, THE APTIMA HPV 16 18/45 GENOTYPE ASSAY CAN BE USED TO TEST SAMPLES FROM WOMEN WITH APTIMA HPV ASSAY POSITIVE RESULTS TO ASSESS THE PRESENCE OR ABSENCE OF HIGH-RISK HPV GENOTYPES 16, 18, AND/OR 45. THIS INFORMATION, TOGETHER WITH THE PHYSICIAN'S ASSESSMENT OF CYTOLOGY HISTORY, OTHER RISK FACTORS, AND PROFESSIONAL GUIDELINES, MAY BE USED TO GUIDE PATIENT MANAGEMENT. 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 16 18/45 GENOTYPE ASSAY CAN BE USED TO TEST SAMPLES FROM WOMEN WITH APTIMA HPV ASSAY POSITIVE RESULTS. THE ASSAY RESULTS WI11 BE USED IN COMBINATION WITH CERVICAL CYTOLOGY TO ASSESS THE PRESENCE OR ABSENCE OF HIGH-RISK HPV GENOTYPES 16, 18, AND/OR 45. THIS INFORMATION, TOGETHER WITH THE PHYSICIAN'S 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.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S006 S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 
S025 S026 S027 S028 S029 S030 
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