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BE-Certain Pregnancy Test

by Natureplex, LLC

510(k) K051963

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 NumberK051963 Date23 Nov 2005ClearedStatusActive

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  • Withdrawn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, 19 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 BE-Certain Pregnancy Test is a rapid, one-step immunochromatographic assay designed for the qualitative detection of human chorionic gonadotropin (hCG) in urine. It functions as an over-the-counter diagnostic device to confirm pregnancy by identifying hCG levels in a urine sample.

This device is supplied as a single-use, non-sterile kit and is intended for home use. It consists of a membrane, absorbent pad, and a fiberglass paper strip impregnated with a lyophilized conjugate. The test is classified under FDA regulation 862.1155 and received a Substantially Equivalent (SESE) determination in a 510(k) review by the Clinical Chemistry advisory committee. No MRI safety or reusable components are indicated.

Other devices from Natureplex, LLC

Questions

AI-generated answers, 19 Sep 2026

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

  • Is the BE-Certain Pregnancy Test suitable for professional medical use, or is it strictly for home testing?

    The BE-Certain Pregnancy Test is explicitly designed for home use as an over-the-counter diagnostic device. While it can be used in clinical settings, its primary intended use is for individual, non-professional testing in a home environment.

  • How many times can I use this pregnancy test, and is it reusable?

    The BE-Certain Pregnancy Test is a single-use device. Each kit is intended for one test only and should not be reused, as reuse could compromise accuracy and reliability.

  • What does the sterility status of the BE-Certain Pregnancy Test mean for its use?

    The test is classified as non-sterile, meaning it is not free from bacteria or other microorganisms. This is typical for over-the-counter urine-based tests like this one, as sterility is not required for home use. However, proper hygiene should be maintained when handling the test.

  • What regulatory pathway was followed for the approval of the BE-Certain Pregnancy Test?

    The BE-Certain Pregnancy Test received a Substantially Equivalent (SESE) determination through a Traditional 510(k) review process by the FDA’s Clinical Chemistry advisory committee. This means it was deemed comparable to a legally marketed predicate device, ensuring its safety and effectiveness for detecting human chorionic gonadotropin (hCG) in urine.

  • How should I store the BE-Certain Pregnancy Test before use?

    While the storage instructions are not explicitly detailed in the provided data, most rapid immunochromatographic pregnancy tests like this one should be stored in a cool, dry place away from direct sunlight and extreme temperatures. Always follow the manufacturer’s included instructions for optimal performance.