# K043443: One Step HCG Urine Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Wondfo Biotech Co., Ltd.
- Decided: Apr 8, 2005 after 115 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: 3 generations back to K941090 (1994). 7 ancestors in all.
14 later devices descend from it; 9 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033658: E.P.T. Pregnancy Test, Unipath, Ltd. (2004) Summary page 2.
- K032992: Unimark Home Pregnancy Test Device, Biotech Atlantic, Inc. (2003) Summary page 2.
- K033041: Acon Quik-Check II Home Pregnancy Test Strip, ACON Laboratories, Inc. (2003) Summary page 2.
- K031798: Good Morning Test, Standard Diagnostics, Inc. (2003) Summary page 2.

## Most influential descendants
- K173229: Preview Digital Pregnancy Test (2018), 2 descendants of its own
- K222305: MissLan™ Digital Pregnancy Rapid Test (2022), 1 descendant of its own
- K200133: hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream (2020), 1 descendant of its own
- K192123: HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream (2019), 1 descendant of its own
- K150063: One Step hCG Pregnancy Test (2015), 1 descendant of its own

## Indications for use
The Guangzhou Wondfo Biotech Co., Ltd. One Step HCG Urine Pregnancy Test is intended for non-professional, over-the-counter use and for professional and laboratory use for the qualitative identification of the elevated levels of human Chorionic Gonadotropin (hCG) in urine to aid in the determination of pregnancy. The One Step HCG Urine Pregnancy Test is intended for use by professional healthcare personnel trained in its use and for Over-the-Counter use.

Source page: https://510kreport.com/device/K043443
Methodology: https://510kreport.com/methodology