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VeriClear Digital Early Result Pregnancy Test

by True Diagnostics, Inc.

510(k) K182328

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 NumberK182328 Date15 May 2019ClearedStatusActive

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  • Withdrawn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 VeriClear Digital Early Result Pregnancy Test is a qualitative lateral flow immunoassay designed for the detection of human chorionic gonadotropin (hCG) in urine. It functions as an over-the-counter diagnostic device, providing a digital readout to indicate the presence or absence of pregnancy through a lateral flow immunochromatographic assay with colloidal gold labeling on a test strip integrated into a plastic housing.

This device is supplied as a single-use, non-sterile test kit in a sealed pouch, including instructions for use and a desiccant package for moisture control during storage. It is classified as a Class II medical device under FDA regulations (product code LCX) and has received FDA 510(k) clearance (K182328). The test strip incorporates electronic/optical components and a microprocessor to process results, which are displayed on an LCD screen.

Other devices from True Diagnostics, Inc.

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 VeriClear Digital Early Result Pregnancy Test used for?

    The VeriClear Digital Early Result Pregnancy Test detects human chorionic gonadotropin (hCG) in urine, a hormone produced during pregnancy. It provides a digital readout to indicate whether hCG is present, confirming pregnancy or its absence. This test is designed for over-the-counter use and is intended for home testing by individuals.

  • How is the VeriClear Digital Early Result Pregnancy Test supplied?

    The test is supplied as a single-use kit in a sealed pouch. Each kit includes the test strip integrated into a plastic housing with an LCD screen, instructions for use, and a desiccant package to maintain moisture control during storage. The desiccant helps preserve the test’s integrity until use.

  • Is the VeriClear Digital Early Result Pregnancy Test sterile?

    No, the VeriClear Digital Early Result Pregnancy Test is non-sterile. It is designed for single-use and intended for home testing, where sterility is not required. The test is packaged in a sealed pouch to protect it from contamination until use.

  • Can the VeriClear Digital Early Result Pregnancy Test be reused?

    No, the VeriClear Digital Early Result Pregnancy Test is explicitly designed for single-use only. Reusing the test could compromise accuracy and reliability, as the test strip and electronic components are not intended to be reused. Always use a new test for each test cycle.

  • How should the VeriClear Digital Early Result Pregnancy Test be stored?

    The test should be stored in a cool, dry place, away from direct sunlight and extreme temperatures. The sealed pouch and desiccant package included in the kit help maintain optimal conditions for the test strip. Avoid storing the test in areas prone to moisture or humidity, as this could affect its performance.