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QuikResponse One Step Midstream Early Pregnancy Test

by Tianjin New Bay Bioresearch Co., Ltd.

510(k) K112449

Active European Union and United States

CE IVDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K112449↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK112449 Date24 Sep 2012ClearedStatusActive
European UnionCE/IVDD EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Full name
Quikresponse One Step Midstream Early Pregrancy Test
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, 18 Sep 2026

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

The QuikResponse One Step Midstream Early Pregnancy Test is a lateral flow immunoassay device designed for the qualitative detection of human chorionic gonadotropin (hCG) in urine. It is intended to provide a preliminary indication of pregnancy by identifying elevated hCG levels, typically detectable as early as five days before the expected menstrual period.

This test is a single-use, over-the-counter diagnostic device supplied as a cassette-based kit. It requires no special storage conditions beyond room temperature and is intended for home use or point-of-care settings. The device has received FDA 510(k) clearance and In Vitro Diagnostic Device (IVDD) authorization, adhering to regulatory standards for pregnancy testing. Each test includes a unique registration number for traceability and compliance.

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Questions

AI-generated answers, 18 Sep 2026

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

  • How soon after conception can this pregnancy test detect hCG levels in urine?

    The QuikResponse One Step Midstream Early Pregnancy Test is designed to detect elevated human chorionic gonadotropin (hCG) levels as early as five days before the expected menstrual period, which corresponds to roughly the time of implantation. This makes it capable of providing a preliminary indication of pregnancy potentially sooner than traditional tests.

  • Is this test intended for professional medical settings or can it be used at home?

    This test is explicitly designed for home use or point-of-care settings, meaning it is intended for use by individuals without requiring a clinical environment. It is a single-use, over-the-counter diagnostic device, making it accessible for self-testing.

  • What storage conditions are required for the QuikResponse One Step Midstream Early Pregnancy Test?

    The test does not require any special storage conditions beyond standard room temperature. This makes it convenient for storage in homes or clinics without the need for refrigeration or controlled environments.

  • Are there different sizes or models of this pregnancy test available?

    The QuikResponse One Step Midstream Early Pregnancy Test is supplied as a cassette-based kit, and the data provided does not indicate multiple sizes or models. It is a singular, standardized design for qualitative detection of hCG in urine.

  • How can I verify the authenticity or traceability of this pregnancy test?

    Each QuikResponse One Step Midstream Early Pregnancy Test includes a unique registration number for traceability and compliance. This feature allows users to verify authenticity and ensures the device meets regulatory standards, though the exact verification process would be outlined in the manufacturer’s instructions.