| 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. |
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| Trade Name | DIGENE HYBRID CAPTURE 2 HPV DNA TEST |
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| Classification Name | kit, dna detection, human papillomavirus |
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| Generic Name | human papillomavirus dna detection kit |
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| Applicant | DIGENE CORP. |
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| PMA Number | P890064 |
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| Supplement Number | S015 |
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| Date Received | 05/28/2004 |
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| Decision Date | 07/29/2004 |
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| Product Code | |
| Advisory Committee |
Microbiology |
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| Supplement Type | real-time process |
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| Supplement Reason | labeling change - minor |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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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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