PMA P920048S003

Device: RAPID FFN FOR THE TLI SYSTEM
Applicant: Hologic, Inc.
PMA number: P920048
Supplement: S003
Product code: LKV
Decision date: 2001-03-09
Classification: Enzyme Immunoassay, Fetal Fibronectin
Generic name: ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
Approval order 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.

Current openFDA PMA Record#

Device: RAPID FFN FOR THE TLI SYSTEM
Applicant: Hologic, Inc.
PMA number: P920048
Supplement: S003
Product code: LKV
Generic name: ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
Decision date: 2001-03-09
Decision code: APPR
Date received: 2000-09-11
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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.