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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 NameCERVISTA HPV 16/18
Classification Namekit, dna detection, human papillomavirus
ApplicantHOLOGIC, INC.
PMA NumberP080015
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 16/18. Cervista hpv 16/18 indications for use: the cervista hpv 16/18 test is an in vitro diagnostic test for the qualitative detection of dna from human papillomavirus (hpv) type 16 and type 18 in cervical specimens. The cervista hpv 16/18 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. Cervista hpv 16/18 test is indicated: 1) in women 30 years and older the cervista hpv 16/1s test can be used adjunctively with the cervista hpv hr test in combination with cervical cytology to screen to assess the presence or absence of high-risk hpv types 16 and 18. This information, together with the physician's assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. 2) to be used adjunctively with the cervista hpv hr test in patients with atypical squamous cells of undetermined significance (asc-us) cervical cytology results, to assess the presence or absence of high-risk hpv types 16 and 18. 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. Cervical specimens that may be tested with the cervista hpv 16/18 test include the following preservation system and collection devices: thinprep pap test preservcyt solution; and ¿ broom-type device (e. G. Rovers cervex brush, wallach papette), or endocervical brush/spatula.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 
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