# K984075: Instant-View Pregnancy Urine Mid-Stream Test

- Pathway: 510(k) (Traditional)
- Applicant: Alfa Scientific Designs, Inc.
- Decided: Feb 16, 1999 after 92 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: 1 generation back to K954178 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954178: Osom Pregnancy Test, Wyntek Diagnostics, Inc. (1995) Summary page 1.

## Indications for use
This test is a qualitative immunoassay for the detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. This test is for Over-The-Counter use only.

Source page: https://510kreport.com/device/K984075
Methodology: https://510kreport.com/methodology