Skip to content

One Step Pregnancy Test

by Spd Swiss Precision Diagnostics GmbH

510(k) K210341

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK210341 Date10 Mar 2022ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
LCX
Device class
Class II
Regulation
21 CFR Part 862.1155
Advisory committee
Clinical Chemistry
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The One Step Pregnancy Test is a Pregnancy Test Kit designed to detect human chorionic gonadotropin (hCG) in urine, indicating pregnancy. It provides a qualitative result within minutes, allowing for early confirmation of pregnancy through a simple, over-the-counter diagnostic process. The device is classified as a Class II medical device under FDA regulations, adhering to standards for diagnostic accuracy and reliability.

This test is intended for home use and requires no professional interpretation. Supplied as a single-use, non-sterile device, it includes all necessary components for a one-step urine collection and result interpretation. The test is approved for FDA 510(k) clearance under the Clinical Chemistry advisory committee and is distributed under the product code LCX. Storage instructions and expiration dates are specified on the packaging, ensuring proper handling before use.

Devices cleared under K210341

4 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K210341
UDI-DISize and differences
DG health One Step Pregnancy Test
DOLGENCORP, LLC
N/A / One Step Pregnancy Test00751774250787 —No longer on the market
Equate One Step Pregnancy Test
Walmart Stores
One Step Pregnancy Test00681131107228 —On the market
First Signal One Step Pregnancy Test
SPD SWISS PRECISION DIAGNOSTICS GMBH
One Step Pregnancy Test00751774013733 —On the market
H.E.B One-Step Cassette Pregnancy Test
H. E. BUTT GROCERY COMPANY
N/A / One-Step Cassette Pregnancy Test00041220549757 —On the market

Similar devices

Other devices filed under FDA product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter).

Other devices from Spd Swiss Precision Diagnostics GmbH

See all devices from Spd Swiss Precision Diagnostics GmbH →