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Platform OneStep Pregnancy Home Test

FDA 510(k)

Class II (US FDA 510(k))

510(k) K960117

by Syntron Bioresearch, Inc.

Identifiers

510(k) Number
K960117 FDA 510(k)
FDA Product Code
LCX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1155 FDA 510(k)
Regulation Number
862.1155 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a solid phase immunoassay in vitro diagnostic test kit for the qualitative determination of human chorionic gonadotropin (hCG) in urine. It functions as an over-the-counter (OTC) pregnancy test, providing a visual result through color comparison to detect early pregnancy.

The test is designed for single-use, non-invasive home use and requires no professional administration. Supplied as a ready-to-use kit, it is intended for OTC sale and does not require regulatory approval beyond its FDA 510(k) clearance under the Clinical Chemistry advisory committee. No sterility or MRI safety considerations apply, as it is a non-invasive, non-implantable diagnostic device.

Frequently asked questions

What is the primary purpose of the Platform Onestep Pregnancy Home Test and how does it work?

The Platform Onestep Pregnancy Home Test is designed as a single-use, over-the-counter (OTC) diagnostic tool for detecting early pregnancy through a qualitative urine test. It functions as a solid-phase immunoassay, meaning it uses antibodies to detect human chorionic gonadotropin (hCG), a hormone produced during pregnancy. Users compare color changes on the test strip to determine the presence of hCG, providing a visual result without requiring professional administration.

Is this device intended for reuse or is it strictly single-use?

This device is strictly single-use only. The manufacturer explicitly states it is designed for one-time use in a home setting, ensuring accuracy and hygiene for each test. Reusing the test could compromise reliability and introduce contamination risks.

How is the Platform Onestep Pregnancy Home Test supplied, and does it require any special handling before use?

The test is supplied as a ready-to-use kit, meaning no additional preparation or assembly is required before use. Since it is a non-invasive, non-sterile diagnostic device, it does not need refrigeration or special storage conditions. Users simply follow the included instructions to collect urine and apply it to the test strip.

What regulatory pathway was followed for this device, and what does that mean for purchasers?

The Platform Onestep Pregnancy Home Test received FDA 510(k) clearance under the Clinical Chemistry advisory committee, classified as a Class II device. This means it was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets established safety and performance standards. Purchasers can rely on this clearance as evidence of regulatory review, though the device remains OTC and does not require prescription.

Are there any special storage requirements for this test kit?

The device does not require refrigeration or sterile storage conditions. Since it is a non-invasive, non-sterile diagnostic kit, it should be stored in a cool, dry place away from direct sunlight or extreme temperatures. Always check the expiration date on the packaging before use to ensure accuracy.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: [PDF] Inverness Medical Innovations - SEC.gov, PLATFORM ONESTEP PREGNANCY HOME TEST (K960117) — FDA 510 (k) | Innolitics, OTC - Over The Counter - FDA, Pregnancy Test - Syntron Bioresearch, Inc., Device Listing 1589369040 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Syntron Bioresearch, Inc.

Sources (1)

  • FDA 510(k) K960117 24 fields · synced Sep 19, 2026