# K230038: MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Decheng Biotechnology Co., Ltd.
- Decided: Feb 28, 2023 after 53 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 4.

## Indications for use
MissLan® Pregnancy Rapid Test (Strip) is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, as an aid in early detection of pregnancy. It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over the counter use. MissLan® Pregnancy Rapid Test (Midstream) is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, as an aid in early detection of pregnancy. It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over the counter use.

Source page: https://510kreport.com/device/K230038
Methodology: https://510kreport.com/methodology