# K123844: Chemtrue HCG Pregnancy Urine Dipstick, HCG Pregnancy Urine Cassette Test,  and HCG Combo Serum/Urine Cassette Test

- Pathway: 510(k) (Traditional)
- Applicant: Chemtron Biotech, Inc.
- Decided: May 30, 2013 after 168 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 K964461 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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 4.
- K964461: One -Step Urine/Serum Combo Pregnancy Card Test, Teco Diagnostics (1997) Summary page 4.

## Indications for use
The Chemntrue® hCG Pregnancy Urine Dipstick Test is a rapid lateral flow qualitative immunoassay for early detection of human chorionic gonadotropin (hCG) in human urine in the device format of Dipstick. The test is designed to aid early detection of pregnancy. The device is intended for Prescription Use Only. The test kits are intended for prescription use including at physician's offices or other Point-Of-Care sites (POC). The Chemntrue® hCG Pregnancy Urine Cassette Test is a rapid lateral flow qualitative immunoassays for early detection of human chorionic gonadotropin (hCG) in human urine in the device format of Cassette format. The test is designed to aid early detection of pregnancy. The device is intended for Prescription Use Only. The test kits are intended for prescription use including at physician's offices or other Point-Of-Care sites (POC). The Chemntrue® hCG Combo (Serum/Urine) Cassette Test is rapid lateral flow qualitative immunoassays for early detection of human chorionic gonadotropin (hCG) in human urine or serum in Cassette format only. The test is designed to aid early detection of pregnancy. The devices are intended for Prescription Use Only. The test kits are for prescription use including professionals at physician's office laboratories (POLs) or Point-Of-Care site (POC).

Source page: https://510kreport.com/device/K123844
Methodology: https://510kreport.com/methodology