# K241978: Shinetell Digital Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou AllTest Biotech Co., Ltd.
- Decided: Aug 13, 2024 after 39 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: 6 generations back to K941090 (1994). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222305: MissLan™ Digital Pregnancy Rapid Test, Guangzhou Decheng Biotechnology Co., Ltd. (2022) Summary page 4.

## Indications for use
ShinetellTM Digital Pregnancy Test is a pregnancy test. It is used for the qualitative detection of hCG in human urine as an aid in early detection of pregnancy. For in vitro diagnostic use, for over the counter use.

Source page: https://510kreport.com/device/K241978
Methodology: https://510kreport.com/methodology