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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameAPTIMA HPV 16 18/45 GENOTYPE ASSAY
Classification Namekit, rna detection, human papillomavirus
ApplicantGEN-PROBE INCORPORATED
PMA NumberP120007
Date Received04/19/2012
Decision Date10/12/2012
Product Code
OYB[ Registered Establishments with OYB ]
Docket Number 12M-1066
Notice Date 11/01/2012
Advisory Committee Microbiology
Clinical Trials NCT01384370
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 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. 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 Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 
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