FDA.reportPublic FDA data

PMA P920048S024

Device
Rapid fFN for the TLilQ System
Applicant
Hologic, Inc.
PMA number
P920048
Supplement
S024
Product code
LKV
Decision date
2023-08-24
Classification
Clinical Toxicology
Generic name
ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
Approval order statement
Approval of a labeling update to provide additional clarity on the specimen collection by indicating that, Only results from specimens obtained during a speculum examination are valid. Results from specimens obtained in any other manner, for example, vaginal examination, are invalid.

Current openFDA PMA Record#

Device
Rapid fFN for the TLilQ System
Applicant
Hologic, Inc.
PMA number
P920048
Supplement
S024
Product code
LKV
Generic name
ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
Decision date
2023-08-24
Decision code
APPR
Date received
2023-07-31
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval of a labeling update to provide additional clarity on the specimen collection by indicating that, Only results from specimens obtained during a speculum examination are valid. Results from specimens obtained in any other manner, for example, vaginal examination, are invalid.