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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namekit, dna detection, human papillomavirus
Generic Namehuman papillomavirus dna detection kit
PMA NumberP890064
Supplement NumberS006
Date Received09/30/1997
Decision Date03/17/1999
Product Code
MAQ[ Registered Establishments with MAQ ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for chaning the solid phase on which the rna:dna hybrids are captured from polystyrene tubes to a 96-well microtiter place addition of a new cervical specimen collection kit (digene cervical sampler), addition of the digene sample conversion kit,a nd the addition of new assay performance characteristics. The device, as modified, will be marketed under the trade name digene hpv test using hybrid capture(r) ii technology (hcii hpv) witht he following indications: the digene hpv test using hybrid capture ii technology is a nucleic acid signal enhanced solution hybridization microplate assay using chemiluminescence for the qualitative detection of eighteen types of human papillomavirus (hpv) dna in cervical specimens. The digene hpv test can differentiate between two hpv dna groups: low risk hpv types 6/11/42/43/44; and high/intermediate risk hpv types 16/18/31/33/35/39/45/51/52/56/58/59/68, but cannot determine the specific hpv type present. Cervical specimens which may be tested with the digene hpv test include the following: 1) specimens collected with the digene cervical sampler; 2) biopsies collected in the digene specimen transport medium; 3) specimens collected using a broom-type collection device and placed in cytye preservcyt solution (refer to the digen sample converstion kit package insert for complete details).