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Pure-Aid Pregnancy Test

by Bio Focus Co., Lt.

510(k) K053452

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 NumberK053452 Date25 May 2006ClearedStatusActive

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  • Withdrawn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 Pure-Aid Pregnancy Test is a qualitative urine test kit designed for the detection of human chorionic gonadotropin (hCG), a hormone produced during pregnancy. It falls under the classification of a pregnancy test kit and is intended for over-the-counter use, providing a simple means for early pregnancy confirmation at home or in clinical settings.

This device is supplied as a single-use, non-sterile test kit and is regulated under FDA 510(k) clearance (K053452) with a classification of Class II. It is intended for use in clinical chemistry settings and is not intended for MRI environments. The test is packaged for individual use and requires no special storage conditions beyond those specified by the manufacturer. Authorisation is granted under the regulation 862.1155 for pregnancy test kits.

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 Pure-Aid Pregnancy Test used for?

    The Pure-Aid Pregnancy Test is a qualitative urine test designed to detect human chorionic gonadotropin (hCG), a hormone produced during pregnancy. It provides a simple, over-the-counter method for confirming early pregnancy at home or in clinical settings, such as laboratories or doctor’s offices.

  • Is the Pure-Aid Pregnancy Test sterile?

    No, the Pure-Aid Pregnancy Test is supplied as a non-sterile device. It is intended for single-use only and does not require sterile conditions for its intended purpose, which is the detection of hCG in urine.

  • How is the Pure-Aid Pregnancy Test supplied?

    The Pure-Aid Pregnancy Test is packaged as a single-use kit. Each kit is designed for one test and does not require special storage conditions beyond those recommended by the manufacturer. It is intended for use in clinical chemistry settings, such as laboratories, or for home use.

  • Can the Pure-Aid Pregnancy Test be reused?

    No, the Pure-Aid Pregnancy Test is explicitly designed for single-use only. Reusing the test could compromise accuracy and reliability, as the test strip may degrade or become contaminated after use.

  • What regulatory approval does the Pure-Aid Pregnancy Test hold?

    The Pure-Aid Pregnancy Test has received FDA 510(k) clearance under the classification of Class II, with the clearance number K053452. This approval is granted under the regulation 862.1155 for pregnancy test kits, confirming its compliance with U.S. regulatory standards for clinical chemistry devices.