# K131166: Sofia (R) HCG Fia

- Pathway: 510(k) (Traditional)
- Applicant: Quidel Corp.
- Decided: Aug 2, 2013 after 100 days
- Product code: JHI (Visual, Pregnancy Hcg, Prescription Use)
- Device class: 2
- Regulation: 21 CFR 862.1155
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K973858 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973858: Cards Q.S. HCG Serum/Urine;Concise Performance Plus HCG-Combo, Quidel Corp. (1997) Summary page 2.

## Indications for use
The Sofia hCG FIA is an immunofluorescence-based lateral flow assay intended for the qualitative detection of human Chorionic Gonadlotropin (hCG) in urine specimens and is designed to aid early detection of pregnancy. The test is intended for prescription use only, including use at point-of-care sites.

Source page: https://510kreport.com/device/K131166
Methodology: https://510kreport.com/methodology