# K171136: LIA Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Lia Diagnostics
- Decided: Nov 20, 2017 after 217 days
- Product code: LCX (Kit, Test, Pregnancy, Hcg, Over The Counter)
- 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 K974159 (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)
- K974159: Osom HCG-Urine Test Model 101, Wyntek Diagnostics, Inc. (1997) Summary page 4.

## Indications for use
Lia Pregnancy Test is intended for non-professional, over-the-counter use for the qualitative identification of the elevated levels of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy.

Source page: https://510kreport.com/device/K171136
Methodology: https://510kreport.com/methodology