Preg-Tex

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K790898 ↗

FDA Product Code

JHJ

Device Class

Class II

Regulation

21 CFR Part 862.1155

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Biologics Intl., Inc. →

• What clinical setting is the Preg-Tex designed for, and how is it different from home pregnancy tests?

  The Preg-Tex is designed exclusively for use in clinical chemistry laboratories and healthcare settings, not for home use. Unlike over-the-counter home pregnancy tests, it employs an agglutination method for qualitative detection of human chorionic gonadotropin (hCG) in urine, adhering to stricter regulatory standards for in vitro diagnostics. Its single-use format and controlled handling requirements ensure accuracy in professional settings where precision is critical.

• Is the Preg-Tex sterile, and what precautions should be taken during use?

  The Preg-Tex is not sterile, so it must be handled under controlled conditions to prevent contamination. Since it’s a single-use diagnostic kit, users should follow the manufacturer’s instructions for proper storage and handling to maintain test integrity. Avoid exposing the device to dust, moisture, or direct contact with unsterile surfaces before use.

• How is the Preg-Tex supplied, and what sizes or models are available?

  The Preg-Tex is supplied as a single-use diagnostic kit—no multi-test or reusable versions are available. The device data does not specify multiple sizes or models, implying a standardized format for qualitative hCG detection in urine. Always refer to the included documentation for exact kit composition and usage instructions.

• What regulatory pathway does the Preg-Tex follow, and which advisory committee reviewed it?

  The Preg-Tex follows the FDA 510(k) clearance pathway, specifically under the Traditional review type, with a decision labeled as *Substantially Equivalent* (SESE). It was reviewed by the FDA’s Clinical Chemistry (CH) Advisory Committee in 1979, ensuring compliance with in vitro diagnostic standards for pregnancy testing under the *Agglutination Method, Human Chorionic Gonadotropin* classification (Product Code: JHJ).