# K222305: MissLan™ Digital Pregnancy Rapid Test

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Decheng Biotechnology Co., Ltd.
- Decided: Nov 30, 2022 after 121 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: 5 generations back to K941090 (1994). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173229: Preview Digital Pregnancy Test, Guangzhou Wondfo Biotech Co., Ltd. (2018) Summary page 4.

## Most influential descendants
- K241978: Shinetell Digital Pregnancy Test (2024), 0 descendants of its own

## Indications for use
MissLanTM Digital Pregnancy Rapid Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in 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/K222305
Methodology: https://510kreport.com/methodology