Biosign Hcg-One Step Pregnancy Test

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K901011 ↗

FDA Product Code

JHI

Device Class

Class II

Regulation

21 CFR Part 862.1155

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Biostix (Tm)Hcg--Simple Pregnancy Test

  Class II

  FDA 510(k) K892654 Active Cleared 19 Jun 1989

• Test, Lactate Dehydrogenase

  Class II

  FDA 510(k) K760345 Active Cleared 27 Oct 1976

• 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 types of settings can this pregnancy test be used in, and what does that mean for my workflow?

  The BioSign HCG-One Step Pregnancy Test is designed for both home use and clinical settings, such as doctor’s offices or labs, requiring no specialized equipment beyond the test cassette itself. Since it’s a single-use, non-sterile device, it’s ideal for point-of-care testing where rapid results are needed. Clinicians can use it for immediate patient confirmation, while patients can self-administer it at home for preliminary pregnancy verification. Results are visually interpreted within minutes, making it convenient for busy workflows.

• Is this test reusable, or do I need to purchase multiple units for repeated testing?

  This test is intended for single-use only, meaning each cassette is designed for one test. If multiple tests are required (e.g., follow-up or retesting), you’ll need to purchase additional units. The non-sterile nature further emphasizes its one-time use to maintain accuracy and reliability.

• How should I store this test, and what conditions are required to keep it effective?

  The BioSign HCG-One Step Pregnancy Test should be stored under standard ambient conditions, meaning no refrigeration or special temperature controls are required. It’s non-sterile, so it doesn’t need sterile storage like surgical instruments. However, keep it in a dry place and away from direct sunlight or extreme temperatures to preserve its integrity until use. Always check the expiration date before testing.

• What does the FDA clearance (K901011) mean for the reliability of this test, and how does it differ from over-the-counter options?

  The FDA clearance under 510(k) K901011 indicates that this test has been evaluated and deemed substantially equivalent to a legally marketed device, meeting regulatory standards for accuracy, safety, and performance. Unlike over-the-counter (OTC) pregnancy tests, which are available without a prescription, this device is prescription-use only, implying it may undergo stricter validation for clinical precision. The clearance also confirms it adheres to Clinical Chemistry standards, ensuring reliability for detecting hCG levels above clinically significant thresholds.