# K103574: Pregnancy One Step Rapid Test

- Pathway: 510(k) (Traditional)
- Applicant: Lehnus & Associates Consulting
- Decided: Jul 28, 2011 after 234 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
The Pregnancy One Step Rapid Test Strip is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadlotropin (hCG) in urine to aid in the early detection of pregnancy. For professional use only. The Pregnancy One Step Rapid Test Cassette is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hOG) in urine to aid in the early detection of pregnancy. For professional use only. The Pregnancy One Step Rapid Midstream Test is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. For OTC self-testing use.

Source page: https://510kreport.com/device/K103574
Methodology: https://510kreport.com/methodology