Rapid fFN for the TLiIQ System
FDA premarket approval P920048/S029 · decided 2026-03-05
Approval details
- PMA number
- P920048
- Supplement
- S029
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Rapid fFN for the TLiIQ System
- Generic name
- ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
- Applicant
- Hologic, Inc.
- Date received
- 2026-02-04
- Decision date
- 2026-03-05
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LKV
- Advisory committee
- Clinical Toxicology
- Expedited review
- No
- Location
- Sunnyvale, CA
- Statement
- to change the sub-supplier for a chemical used in the manufacture of the Rapid fFN Control Kit and Rapid fFN Cassette Kit
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510(k) clearances by this applicant
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| Aptima SARS-CoV-2 Assay (K243396) | Hologic, Inc. | 2025-02-13 |
| Aptima CMV Quant Assay (K243935) | Hologic, Inc. | 2025-01-17 |
| Aptima BV Assay; Aptima CV/TV Assay (K243345) | Hologic, Inc. | 2024-11-25 |
| Panther Fusion SARS-CoV-2/Flu A/B/RSV assay (K242465) | Hologic, Inc. | 2024-11-15 |
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