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HCG-One Step Pregnancy Test

FDA 510(k)

Class II (US FDA 510(k))

510(k) K974425

by Princeton Biomeditech Corp.

Identifiers

510(k) Number
K974425 FDA 510(k)
FDA Product Code
DHA 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)

The HCG-One Step Pregnancy Test is a rapid, qualitative in vitro diagnostic device designed to detect human chorionic gonadotropin (hCG) in urine samples. It functions as a solid-phase, two-site immunometric assay using monoclonal and polyclonal antibodies to identify early pregnancy through a lateral flow immunoassay principle.

This device is intended for professional use in clinical settings, including hospitals, laboratories, and physicians’ offices. Supplied as a single-use, non-sterile test, it provides visual results for early pregnancy confirmation. The device is classified under FDA’s 510(k) pathway (K974425) and adheres to regulatory standards for Class II diagnostic tests (DHA product code).

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: BioSign® hCG (Pregnancy) Test (for visual interpretation ... - Chirus, Biosign Hcg-one Step Pregnancy Test, Accusign Hcg-one Step Pregnancy ..., www.accessdata.fda.gov

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Princeton Biomeditech Corp.

Sources (1)

  • FDA 510(k) K974425 24 fields · synced Sep 19, 2026