PMA P920048S009

Device: RAPID FFN FOR THE TLIIQ SYSTEM
Applicant: Hologic, Inc.
PMA number: P920048
Supplement: S009
Product code: LKV
Decision date: 2015-06-24
Classification: Enzyme Immunoassay, Fetal Fibronectin
Generic name: ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
Approval order 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.

Current openFDA PMA Record#

Device: RAPID FFN FOR THE TLIIQ SYSTEM
Applicant: Hologic, Inc.
PMA number: P920048
Supplement: S009
Product code: LKV
Generic name: ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
Decision date: 2015-06-24
Decision code: APPR
Date received: 2015-04-09
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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.