# K233624: HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Midstream Rx

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou Aichek Medical Technology Co., Ltd.
- Decided: Apr 12, 2024 after 151 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 K941090 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043443: One Step HCG Urine Pregnancy Test, Guangzhou Wondfo Biotech Co., Ltd. (2005) Summary page 5.

## Indications for use
The hCG One Step Pregnancy Test Strip Rx is intended for qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in early detection of pregnancy. For in Vitro Diagnostic Use Only. For prescription use. The hCG One Step Pregnancy Test Midstream Rx is intended for qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in early detection of pregnancy. For in Vitro Diagnostic Use Only. For prescription use. The hCG One Step Pregnancy Test Strip OTC is intended for qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in early detection of pregnancy. For in Vitro Diagnostic Use Only. For over-the-counter use.. The hCG One Step Pregnancy Test Midstream OTC is intended for qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in early detection of pregnancy. For in Vitro Diagnostic Use Only. For over-the-counter use.

Source page: https://510kreport.com/device/K233624
Methodology: https://510kreport.com/methodology