# K023037: Mid Stream Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Diagnostics, Inc.
- Decided: Apr 9, 2003 after 209 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: 2 generations back to K926204 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983090: Acon Midstream Pregnancy Test, ACON Laboratories, Inc. (1998) Summary page 1.

## Indications for use
The Test is a qualitative immunoassay intended for non professional / Over The Counter Use for qualitative detection of the human chorionic gonadotropin (hCG) in urine. The test is for use as an aid in the diagnosis of early pregnancy.

Source page: https://510kreport.com/device/K023037
Methodology: https://510kreport.com/methodology