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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.
 
DeviceDIGENE HYBRID CAPTURE 2 HPV DNA TEST
Generic NameKIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
ApplicantQiagen Gaithersburg, Inc.
19300 Germantown Rd.
Germantown, MD 20874
PMA NumberP890064
Supplement NumberS015
Date Received05/28/2004
Decision Date07/29/2004
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR REVISIONS TO THE ASSAY'S LABELING PERFORMANCE CHARACTERISTICS SECTION. THE CHANGE INVOLVES MOVING THE SECTION "RELATIVE FALSE-POSITIVE AND FALSE-NEGATIVE RATE" FROM THE LABELING'S CLINICAL PERFORMANCE SECTION TO THE ANALYTICAL SECTION WITH NARRATIVE REVISIONS. THE NEW SECTION IS ENTITLED "EXTERNAL STUDY USING CLINICAL SPECIMENS." A NEW NOTE HAS BEEN ADDED TO THE CURRENT LABELING'S TABLE 10 REFERENCED TO SNIJDERS, PJF, VAN DE BRULE, AJC, AND MEIJER, CJLM, "THE CLINICAL RELEVANCE OF HUMAN PAPILLOMAVIRUS TESTING: RELATIONSHIP BETWEEN ANALYTICAL AND CLINICAL SENSITIVITY". J PATHOL 2003; 201: 1-6.
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