RAPID FFN FOR THE TLIIQ SYSTEM
FDA premarket approval P920048/S009 · decided 2015-06-24
Approval details
- PMA number
- P920048
- Supplement
- S009
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RAPID FFN FOR THE TLIIQ SYSTEM
- Generic name
- ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
- Applicant
- Hologic, Inc.
- Date received
- 2015-04-09
- Decision date
- 2015-06-24
- Days to decision
- 76 days
- Decision code
- APPR
- Product code
- LKV
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Sunnyvale, CA
- Statement
- APPROVAL FOR THE USE OF A NEW RESIN IN THE PLASMA FIBRONECTIN (PFN) AFFINITY COLUMN USED TO PURIFY THE A120 FETAL FIBRONECTIN SPECIFIC ANTIBODY CONTAINED IN THE RAPID FFN TEST FOR THE TLIIQ SYSTEM. ADDITIONALLY, THE IMPLEMENTATION OF A MODIFIED ARGININE CONTAINING NEUTRALIZATION BUFFER TO DECREASE PRECIPITATION OF THE A120 ANTIBODY FROM THE BUFFER.
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