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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
Generic Namekit, dna detection, human papillomavirus
19300 germantown road
germantown, MD 20874
PMA NumberP890064
Supplement NumberS006
Date Received09/30/1997
Decision Date03/17/1999
Product Code MAQ 
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH 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).