RAPID FFN FOR THE TLI SYSTEM
FDA premarket approval P920048/S003 · decided 2001-03-09
Approval details
- PMA number
- P920048
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RAPID FFN FOR THE TLI SYSTEM
- Generic name
- ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
- Applicant
- Hologic, Inc.
- Date received
- 2000-09-11
- Decision date
- 2001-03-09
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- LKV
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Sunnyvale, CA
- Statement
- APPROVAL FOR THE FOLLOWING: 1) A CHANGE IN THE CALIBRATION PROCEDURE THAT ALLOWS FOR EXTENDED CALIBRATION, ACCOMPLISHED WITH A SOFTWARE MODIFICATION AND NO LONGER REQUIREING THE USE OF THE FFN POSITIVE REFERENCE CALIBRATOR; AND 2) THE ADDITION OF A QUALITY CONTROL COMPONENT, THE TLI QC CASSETTE, FOR THE TLI ANALYZER COUPLED WITH A DECREASE IN FREQUENCY OF TESTING LIQUID CONTROLS.
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