Aptima HPV 16 18/45 Genotype Assay
FDA premarket approval P120007/S030 · decided 2023-06-02
Approval details
- PMA number
- P120007
- Supplement
- S030
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Aptima HPV 16 18/45 Genotype Assay
- Generic name
- Kit, rna detection, human papillomavirus
- Applicant
- Gen-Probe Incorporated
- Date received
- 2022-03-28
- Decision date
- 2023-06-02
- Days to decision
- 431 days
- Decision code
- APPR
- Product code
- OYB
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- Approval for the addition of manual post-cytology (cytology by ThinPrep Genesis Processor) aliquot, pre-cytology aliquot and post-cytology (cytology by ThinPrep Genesis Processor) aliquot removed by the ThinPrep Genesis Processor as acceptable samples for the Aptima HPV Assay and Aptima HPV 16 18/45 Genotype Assay.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| APTIMA TRICHOMONAS VAGINALIS ASSAY (DEN110012) | Gen-Probe Incorporated | 2011-04-19 |