APTIMA HPV ASSAY
FDA premarket approval P100042/S007 · decided 2015-11-24
Approval details
- PMA number
- P100042
- Supplement
- S007
- 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
- 2015-08-12
- Decision date
- 2015-11-24
- Days to decision
- 104 days
- Decision code
- APPR
- Product code
- OYB
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- APPROVAL FOR A CHANGE TO THE APTIMA HPV ASSAY SOFTWARE FROM VERSION 4.2.0 TO VERSION 4.2.1. THIS CHANGE IS BEING IMPLEMENTED TO REDUCE THE PROBE REAGENT MIXING SPEED IN THE HYBRIDIZATION PROTECTION ASSAY (HPA) INCUBATOR FROM 14 HZ TO 5 HZ ON THE TIGRIS SYSTEM. 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
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| APTIMA TRICHOMONAS VAGINALIS ASSAY (DEN110012) | Gen-Probe Incorporated | 2011-04-19 |