# K963341: Midstream Onestep Pregnancy Home Test

- Pathway: 510(k) (Traditional)
- Applicant: Syntron Bioresearch, Inc.
- Decided: Dec 2, 1996 after 98 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Besure Plus OneStep immunoassay: named in the summary without a submission number

## Indications for use
Midstream OneStep pregnancy test is Syntron Bioresearch, Inc. name for OTC use of solid phase immunoassay in vitro diagnostic test kit for the qualitative determination of human Chorionic Gonadotropin (hCG) in urine.

Source page: https://510kreport.com/device/K963341
Methodology: https://510kreport.com/methodology