RAPID FFN CONTROL KIT

FDA premarket approval P920048/S008 · decided 2014-07-24

Approval details

PMA number

P920048

Supplement

S008

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

RAPID FFN CONTROL KIT

Generic name

ENZYME IMMUNOASSAY, FETAL FIBRONECTIN

Applicant

Hologic, Inc.

Date received

2014-06-24

Decision date

2014-07-24

Days to decision

30 days

Decision code

OK30

Product code

LKV

Advisory committee

Clinical Chemistry

Expedited review

No

Location

Sunnyvale, CA

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.

510(k) clearances by this applicant