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Multi-Use Electronic Pregnancy Test LCX

by Mizuho USA, Inc.

510(k) K060825

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK060825 Date19 Jun 2006ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0469-2007 FDA Unclassified (pre-2012) initiated 17 Nov 2006

    False positives-the firm has received a higher than expected rate of complaints regarding false-positive results.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Multi-Use Electronic Pregnancy 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, 20 Sep 2026

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

This device is a Kit, Test, Pregnancy, HCG, Over-the-Counter diagnostic tool, classified under Clinical Chemistry. It is designed for the qualitative detection of human chorionic gonadotropin (hCG) in urine, enabling early pregnancy confirmation through an in-vitro diagnostic method.

The test is intended for multi-use in a retail or over-the-counter setting. It has received FDA 510(k) clearance under the Traditional pathway, with a decision code of SESE (Substantially Equivalent). Supplied as a reusable electronic device, it is regulated under 21 CFR 862.1155 and requires no specific sterility guarantees beyond standard handling precautions. The product code LCX identifies this specific model.

Other devices from Mizuho USA, Inc.

Questions

AI-generated answers, 20 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 this pregnancy test designed for single-use or can it be reused multiple times in a clinical or retail setting?

    This device is explicitly designed for multi-use in retail or over-the-counter settings. It is supplied as a reusable electronic pregnancy test, meaning it can be used repeatedly for detecting human chorionic gonadotropin (hCG) in urine samples, provided standard handling and maintenance guidelines are followed.

  • What regulatory pathway and classification does this pregnancy test follow, and what does that mean for its use?

    This device received FDA 510(k) clearance under the Traditional pathway and is classified as Substantially Equivalent (SESE). It falls under 21 CFR 862.1155 and is categorized under Clinical Chemistry. This means it is regulated as an in-vitro diagnostic device for qualitative detection of hCG, ensuring it meets FDA standards for safety and performance while being available for over-the-counter use.

  • Does this electronic pregnancy test require any special sterility precautions, or is it intended for non-sterile use?

    The device does not require specific sterility guarantees beyond standard handling precautions. Since it is a reusable electronic pregnancy test for over-the-counter use, it is not classified as a sterile medical device. Proper cleaning and maintenance as instructed by the manufacturer are recommended to ensure accurate and reliable results.

  • How do I identify the correct model or variant of this pregnancy test, especially since multiple registration numbers are listed?

    The specific model of this device is identified by the product code LCX. While multiple registration numbers (e.g., 3013332582, 3009238284, etc.) are associated with variations or lot-specific registrations, the core product—the multi-use electronic pregnancy test—is consistently referenced under this code. Always verify the packaging or documentation for the LCX designation to confirm the correct model.

  • Is this device intended for use in healthcare facilities, or is it primarily for home or retail testing?

    This device is intended for multi-use in retail or over-the-counter settings, meaning it is designed for use outside of clinical or healthcare facility environments. It is classified as an over-the-counter diagnostic tool, making it accessible for home testing or retail purchase without requiring a prescription or professional administration.