Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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 ASSAY
Generic NameKit, rna detection, human papillomavirus
ApplicantGen-Probe Incorporated
10210 Genetic Center Dr.
San Diego, CA 92121
PMA NumberP100042
Date Received11/05/2010
Decision Date10/28/2011
Product Code OYB 
Docket Number 11M-0792
Notice Date 11/04/2011
Advisory Committee Microbiology
Clinical TrialsNCT00973362
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE APTIMA HPV ASSAY.APTIMA HPV ASSAY INDICATIONS FOR USE:THE APTIMA HPV ASSAY IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE QUALITATIVE DETECTIONOFE6/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 THE14 HIGH-RISK TYPES. CERVICAL SPECIMENS IN THINPREP PAP TEST VIALS CONTAINING PRESERVCYT SOLUTIONAND COLLECTED WITH BROOM-TYPE OR CYTOBRUSH/ SPATULA COLLECTION DEVICES* MAY BE TESTED WITH THEAPTIMA HPV ASSAY. THE ASSAY IS USED WITH THE TIGRIS DTS SYSTEM. THE USE OF THE TEST IS INDICATED:I. TO SCREEN PATIENTS 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 TOCOLPOSCOPY. 2. IN WOMEN 30 YEARS AND OLDER, THE APTIMA HPV ASSAY CAN BE USED WITH CERVICAL CYTOLOGYTO ADJUNCTIVELY SCREEN TO ASSESS THE PRESENCE OR ABSENCE OF HIGH-RISK HPV TYPES. 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 S005 S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 
S025 S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 
S037 S038 S039 
-
-