# K210341: One Step Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Spd Swiss Precision Diagnostics GmbH
- Decided: Mar 10, 2022 after 398 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 K012215 (2001). 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)
- K012215: Quik-Check Home Pregnancy Test, ACON Laboratories, Inc. (2001) Summary page 4.

## Indications for use
One Step Pregnancy Test is an over-the-counter lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. The visual test is intended for home use as an aid in early detection of pregnancy. The test is indicated for use from 4 days before the day of the expected period (5 days before the day of the missed period).

Source page: https://510kreport.com/device/K210341
Methodology: https://510kreport.com/methodology