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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.
Classification Namekit, dna detection, human papillomavirus
ApplicantHOLOGIC, INC.
PMA NumberP080014
Date Received04/28/2008
Decision Date03/12/2009
Product Code
MAQ[ Registered Establishments with MAQ ]
Docket Number 09M-0299
Notice Date 06/30/2009
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the cervista hpv hr and genfind dna extraction kit. Cervista hpv hr indications for use: the cervista hpv hr test is an in vitro diagnostic test for the qualitative detection of dna from 14 high-risk- human papillomavirus (hpv) types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) in cervical specimens. The cervista hpv hr test cannot determine the specific hpv type present. The cervista hpv hr test uses the invader chemistry, a signal amplification method for detection of specific nucleic acid sequences. This method uses two types of isothermal reactions: a primary reaction that occurs on the targeted dna sequence and a secondary reaction that produces a fluorescent signal. The cervista hpv hr test is indicated: 1) to screen patients with atypical squamous cells of undetermined significance (ascus) cervical cytology results to determine the need for referral to colposcopy. 2) in women 30 years and older the cervista hpv hr test 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 physician's assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. Cervical specimens that may be tested with the cervista hpv hr test include the following preservation system collection media and collection devices: ¿ thinprep pap test preservcyt solution ¿ broom-type device (e. G. Rovers cervex brush, wallach papette), or endocervical brush/spatula. Genfind dna extraction kit indication for use: the genfind dna extraction kit is intended for use in the extraction of dna from cervical specimens collected in thinprep pap test preservcyt solution for testing by the cervista hpv hr and cervista hpv 16/18 tests.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
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