Biostix (Tm)Hcg--Simple Pregnancy Test

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K892654 ↗

FDA Product Code

DHA

Device Class

Class II

Regulation

21 CFR Part 862.1155

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K760345 Active Cleared 27 Oct 1976

• Biosign Hcg-One Step Pregnancy Test

  Class II

  FDA 510(k) K901011 Active Cleared 4 May 1990

• Alkaline Phosphatase (Alp)/Pnpp

  Class II

  FDA 510(k) K761315 Active Cleared 24 Feb 1977

• Biospot Hcg-Rapid Pregnancy Test

  Class II

  FDA 510(k) K894705 Active Cleared 18 Oct 1989

• Lifesign Mi Myoglobin

  Class II

  FDA 510(k) K942052 Active Cleared 7 Feb 1995

• Biostix I. Hcg - One Step Pregnancy Test

  Class II

  FDA 510(k) K894750 Active Cleared 18 Oct 1989

See all devices from Princeton Biomedix →

• What is the Biostix HCG Simple Pregnancy Test used for?

  The Biostix HCG Simple Pregnancy Test is designed to detect human chorionic gonadotropin (hCG) in urine, a hormone produced during pregnancy. It serves as a qualitative diagnostic tool to identify early pregnancy by measuring elevated hCG levels, providing a simple visual result to confirm pregnancy status.

• How is the Biostix HCG Simple Pregnancy Test supplied and intended for use?

  The Biostix HCG Simple Pregnancy Test is supplied as a single-use, non-sterile device. It is intended for both home and clinical use, requiring no special storage conditions beyond protection from extreme temperatures and moisture. Always follow the included instructions for accurate results.

• Is the Biostix HCG Simple Pregnancy Test reusable or single-use?

  This test is explicitly designed for single-use only. Each device is intended to be used once and then discarded. Reusing the test could compromise accuracy and reliability, so adhering to single-use guidelines is essential for proper function.

• What storage conditions are required for the Biostix HCG Simple Pregnancy Test?

  The Biostix HCG Simple Pregnancy Test does not require specialized storage conditions. Simply protect it from extreme temperatures and moisture to maintain its integrity. Store in a cool, dry place until use, ensuring the device remains in its original packaging until ready for testing.

• Is the Biostix HCG Simple Pregnancy Test approved for MRI use?

  No, the Biostix HCG Simple Pregnancy Test is explicitly not intended for MRI use. It must be used strictly according to the provided instructions, and exposure to MRI environments is not recommended as it could affect the device’s performance or safety.