APTIMA HPV ASSAY
FDA premarket approval P100042/S001 · decided 2013-07-15
Approval details
- PMA number
- P100042
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- APTIMA HPV ASSAY
- Generic name
- Kit, rna detection, human papillomavirus
- Applicant
- Gen-Probe Incorporated
- Date received
- 2012-10-04
- Decision date
- 2013-07-15
- Days to decision
- 284 days
- Decision code
- APPR
- Product code
- OYB
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- APPROVAL FOR THE ADDITION OF THE PANTHER SYSTEM TO THE APTIMA® HPV ASSAY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME APTIMA® HPV ASSAY. THE APTIMA HPV ASSAY IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE QUALITATIVE DETECTION OF E6/E7 VIRAL MESSENGER RNA (MRNA) FROM 14 HIGH-RISK TYPES OF HUMAN PAPILLOMAVIRUS (HPV) IN CERVICAL SPECIMENS. THE HIGH-RISK HPV TYPES DETECTED BY THE ASSAY INCLUDE: 16, 18, 31, 33, 35, 39, 45, 51, 52,56, 58, 59, 66, AND 68. THE APTIMA HPV ASSA
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| APTIMA TRICHOMONAS VAGINALIS ASSAY (DEN110012) | Gen-Probe Incorporated | 2011-04-19 |