PMA P920048S008

Device: RAPID FFN CONTROL KIT
Applicant: Hologic, Inc.
PMA number: P920048
Supplement: S008
Product code: LKV
Decision date: 2014-07-24
Classification: Enzyme Immunoassay, Fetal Fibronectin
Generic name: ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
Approval order statement: CHANGE TO ADD AN INTERMEDIATE SOLUTION IN THE MANUFACTURING PROCESS OF POSITIVE REFERENCE CALIBRATOR, TO MODIFY THE PERSONNEL IN CHARGE OF IN-PROCESS MANUFACTURING TESTING AND TO INCREASE THE NUMBER OF REPLICATES IN BULK SOLUTION CONCENTRATION VERIFICATION PROCEDURE FOR BOTH POSITIVE REFERENCE CALIBRATOR AND POSITIVE CONTROL. THE POSITIVE REFERENCECALIBRATOR AND THE POSITIVE CONTROL ARE COMPONENTS OF THE RAPID FFN CONTROL KIT FOR USE WITH THE TLIIQ ANALYZER AND FFN ELISA TEST.

Current openFDA PMA Record#

Device: RAPID FFN CONTROL KIT
Applicant: Hologic, Inc.
PMA number: P920048
Supplement: S008
Product code: LKV
Generic name: ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
Decision date: 2014-07-24
Decision code: OK30
Date received: 2014-06-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO ADD AN INTERMEDIATE SOLUTION IN THE MANUFACTURING PROCESS OF POSITIVE REFERENCE CALIBRATOR, TO MODIFY THE PERSONNEL IN CHARGE OF IN-PROCESS MANUFACTURING TESTING AND TO INCREASE THE NUMBER OF REPLICATES IN BULK SOLUTION CONCENTRATION VERIFICATION PROCEDURE FOR BOTH POSITIVE REFERENCE CALIBRATOR AND POSITIVE CONTROL. THE POSITIVE REFERENCECALIBRATOR AND THE POSITIVE CONTROL ARE COMPONENTS OF THE RAPID FFN CONTROL KIT FOR USE WITH THE TLIIQ ANALYZER AND FFN ELISA TEST.