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One-Step Pregnancy Test

by Amerisource Pharmacal, Inc.

510(k) K031271

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK031271 Date17 Jun 2003ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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

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 an immunochromatographic lateral flow assay for qualitative hCG detection in urine. It utilizes a combination of monoclonal-dye conjugate and polyclonal-solid phase antibodies to detect human chorionic gonadotropin (hCG) in urine samples.

The device is intended for over-the-counter use and is supplied as a test kit. It detects hCG at a concentration level of 25 mIU/ml and is authorized under FDA 510(k) clearance K031271 with product code LCX and regulation number 862.1155.

Questions

AI-generated answers, 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.

  • What is the One-Step Pregnancy Test used for?

    The One-Step Pregnancy Test is used for the qualitative detection of human chorionic gonadotropin (hCG) in urine samples to determine pregnancy status. It is intended for over-the-counter use by consumers.

  • How is the One-Step Pregnancy Test supplied and what is its format?

    The device is supplied as a test kit in an immunochromatographic lateral flow assay format. It uses a monoclonal-dye conjugate and polyclonal-solid phase antibodies to detect hCG in urine.

  • What is the detection sensitivity of the One-Step Pregnancy Test?

    The One-Step Pregnancy Test detects hCG at a concentration level of 25 mIU/ml in urine, which is the sensitivity threshold specified in its authorization.

  • Is the One-Step Pregnancy Test intended for single use or multiple uses?

    The One-Step Pregnancy Test is designed for single-use only, as it is a disposable test kit intended for one-time qualitative hCG detection in urine samples.

  • What regulatory authorization does the One-Step Pregnancy Test have?

    The One-Step Pregnancy Test is authorized under FDA 510(k) clearance K031271 with product code LCX and regulation number 862.1155, classified as a Class II device.