# K050305: One Step HCG Pregnancy Urine Test Formats: Strip, Cassette and Midstream, Models BM-1-1, BM-1-2, BM-1-3, BM-2-1, BM-2-2

- Pathway: 510(k) (Traditional)
- Applicant: Bioscreen Medical, Inc.
- Decided: May 23, 2005 after 104 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
One Step hCG Pregnancy Urine Test device is a qualitative, two sites sandwich immunoassay test device designed for the determination of human chorionic gonadotropin (hCG) concentration in urine samples, and therefore is an aid in the early detection of pregnancy. These test devices available in strip, cassette and midstream formats are intended for over-the-counter (OTC) use. The test devices in cassette and strip format are for professional use as well. For in-vitro diagnostic use only. One Step hCG Pregnancy Urine/Serum Test device is a qualitative, two sites sandwich immunoassay test device designed for the determination of human chorionic gonadotropin (hCG) concentration in urine and serum samples, and therefore is an aid in the early detection of pregnancy. These test devices available in strip and cassette formats are intended for professional use only. For in-vitro diagnostic use only.

Source page: https://510kreport.com/device/K050305
Methodology: https://510kreport.com/methodology