# K212418: hCG One Step Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Healstone Biotech, Inc.
- Decided: Jun 30, 2022 after 331 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: 4 generations back to K992232 (1999). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123436: First Response Early Result Pregnancy Test, Church & Dwight Co., Inc. (2013) Summary page 5.

## Indications for use
The hCG One Step Pregnancy Test is an in vitro diagnostic test for the qualitative determination of human chorionic gonadotropin hormone in human urine samples. It is used as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.

Source page: https://510kreport.com/device/K212418
Methodology: https://510kreport.com/methodology