APTIMA HPV ASSAY
FDA premarket approval P100042 · decided 2011-10-28
Approval details
- PMA number
- P100042
- Trade name
- APTIMA HPV ASSAY
- Generic name
- Kit, rna detection, human papillomavirus
- Applicant
- Gen-Probe Incorporated
- Date received
- 2010-11-05
- Decision date
- 2011-10-28
- Days to decision
- 357 days
- Decision code
- APPR
- Product code
- OYB
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- APPROVAL FOR THE APTIMA HPV ASSAY.APTIMA HPV ASSAY INDICATIONS FOR USE:THE APTIMA HPV ASSAY IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE QUALITATIVE DETECTIONOFE6/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 ASSAY DOES NOT DISCRIMINATE BETWEEN THE14 HIGH-RISK TYPES. CERVICAL SPECIMENS IN THINPREP PAP TEST V
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| APTIMA TRICHOMONAS VAGINALIS ASSAY (DEN110012) | Gen-Probe Incorporated | 2011-04-19 |