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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.
 
DeviceHYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST AND HYBRID CAPTURE HPV DNA TEST
Generic NameKIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
ApplicantQIAGEN GAITHERSBURG, INC
19300 Germantown Road
Germantown, MD 20874
PMA NumberP890064
Supplement NumberS013
Date Received10/01/2003
Decision Date11/07/2003
Product Code MAQ 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR: 1) MODIFICATION OF HYBRIDIZATION PROCEDURAL STEPS AND SEQUENCE; THIS MODIFICATION ENTAILS REVERSING THE ADDITION ORDER OF THE HPV RNA PROBES AND DENATURED SPECIMEN WITH NO CHANGE IN PROBE OR SPECIMEN VOLUME. AN ADDITIONAL 10 MINUTE INCUBATION PERIOD AT ROOM TEMPERATURE (15 DEGREES C TO 30 DEGREES C) WAS ADDED AFTER REMOVAL OF THE SPECIMEN FROM THE 65 += 2 DEGREES C, 60 MINUTES HYBRIDIZATION INCUBATION STEP. 2) ADDITION OF AN EQUIVOCAL RESULT ZONE, WHICH REQUIRES REPEATING SPECIMENS THAT HAVE RESULTS WITHIN THIS RESULT ZONE, FOR SPECIMENS COLLECTED IN PRESERVCYT TRANSPORT MEDIUM. THIS EQUIVOCAL RESULT ZONE HAS BEEN ESTABLISHED TO BE >=1.0 AND <+ 2.5 RLU/CO. 3)_ REMOVAL OF THE EQUIVOCAL RESULT ZONE FROM SPECIMENS COLLECTED IN THE DIGENE SPECIMEN TRANSPORT MEDIUM.
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