• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
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 NameCOBAS HPV TEST
Classification Namekit, dna detection, human papillomavirus
Generic Namehuman papillomavirus dna test detection kit
ApplicantROCHE MOLECULAR SYSTEMS, INC.
PMA NumberP100020
Date Received06/01/2010
Decision Date04/19/2011
Product Code
MAQ[ Registered Establishments with MAQ ]
Docket Number 11M-0300
Notice Date 05/06/2011
Advisory Committee Microbiology
Clinical Trials NCT00709891
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for the cobas hpv test. Cobas hpv test indications for use: the cobas hpv test is a qualitative in vitro test for the detection of human papillomavirus (hpv) in patient specimens. The test utilizes amplification of target dna by the polymerase chain reaction (pcr) and nucleic acid hybridization for the detection of 14 high-risk (hr) hpv types in a single analysis. The test specifically identifies types hpv 16 and hpv 18 while concurrently detecting the rest of the rest of the high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68). The cobas hpv test is indicated: 1) to screen patients 21 years and older with asc-us (atypical squamous cells of undetermined significance) cervical cytology test results to determine the need for referral to colposcopy; and 2) to be used in patients 21 years and older with asc-us cervical cytology results, to assess the presence or absence of high-risk hpv genotypes 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; 3) in women 30 years and older, the cobas hpv 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; and 4) in women 30 years and older, the cobas hpv test can be used to assess the presence or absence of hpv genotypes 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. (see approval order for additional approval statement detail).
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 
-
-