# K230741: Macro & Micro-Test HCG Pregnancy Test Midstream

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
- Decided: Oct 13, 2023 after 210 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.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150063: One Step hCG Pregnancy Test, Coretests, Inc. (2015) Summary page 4.

## Indications for use
Macro & Micro-Test HCG Pregnancy Test Midstream is intended for over-the-counter use for qualitative detection of hCG hormone in urine to aid early detection of pregnancy.

Source page: https://510kreport.com/device/K230741
Methodology: https://510kreport.com/methodology