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Ez Sure Onestep Early Pregnancy Test

by Excel Scientific, Inc.

510(k) K962580

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 NumberK962580 Date29 Aug 1996ClearedStatusActive

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  • Withdrawn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, 23 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 Ez Sure Onestep Early Pregnancy Test is an in‑vitro diagnostic test kit that uses a solid‑phase migratory chromatography immunoassay to qualitatively detect human chorionic gonadotropin (hCG) in urine. It is classified as a pregnancy test kit and is intended for over‑the‑counter use by consumers to determine early pregnancy.

The kit is supplied as a single‑use, sterile test device for home use. It is a Class II medical device cleared through FDA 510(k) (K962580) with product code LCX and clearance type Traditional. The device is regulated under 21 CFR 862.1155, was received on 1996‑07‑01, and the decision date was 1996‑08‑29. It is marketed for OTC use and does not require a prescription.

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