# K131931: Chemtrue (R) HCG Pregnancy Urine Midstream Test

- Pathway: 510(k) (Traditional)
- Applicant: Chemtron Biotech, Inc.
- Decided: Jul 26, 2013 after 29 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 K990578 (1999). 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)
- K990578: Osom Card II HCG-Urine Test, Model 102, Wyntek Diagnostics, Inc. (1999) Summary page 1.

## Indications for use
The Chemtrueo IICG Pregnancy Urine Midstream Urine Test isa rapid lateral flow qualitative immunoassay for early detection of human chorionic gonadotropin (bCG) in human urine in midstream format. The test is designed to aid early detection of pregnancy by home users. The device is intended for Over- The-Counter (OTC) Use.

Source page: https://510kreport.com/device/K131931
Methodology: https://510kreport.com/methodology