E.P.T. Certainty 1-STEP Pregnancy Test

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K061769 ↗

FDA Product Code

LCX

FDA applicant

Unipath , Ltd.

Device Class

Class II

Regulation

21 CFR Part 862.1155

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Clearblue Easy

  Class II

  FDA 510(k) K911566 Active Cleared 6 May 1991

• Immunoglobulins G

  Class II

  FDA 510(k) K873870 Active Cleared 13 Oct 1987

• Cefepine Antimicrobial Susceptibility Test Disc

  Class II

  FDA 510(k) K964495 Active Cleared 7 Feb 1997

• Turbox Fibrinogen

  Class II

  FDA 510(k) K884179 Active Cleared 20 Dec 1988

• Clearblue Easy Earliest Results Pregnancy Test

  Class II

  FDA 510(k) K040341 Active Cleared 8 Mar 2004

• Cell-Dyn 3000A Multi-Parameter Auto Hema Analzyer

  Class II

  FDA 510(k) K913305 Active Cleared 22 Nov 1991

See all devices from Unipath, Ltd. →

• What is the E.P.T. Certainty 1-Step Pregnancy Test used for?

  It is intended for the detection of human chorionic gonadotropin (hCG) in urine to determine pregnancy. The test can be used from four days before the expected period, providing early results for users seeking confirmation of pregnancy.

• How is the E.P.T. Certainty 1-Step Pregnancy Test supplied and is it reusable?

  The device is supplied as a single-use test kit and is not designed for reuse. Each test is intended for one-time application only, ensuring reliable performance and reducing the risk of contamination or inaccurate results from repeated use.

• What regulatory clearance does the E.P.T. Certainty 1-Step Pregnancy Test have?

  The device is authorized under FDA 510(k) clearance with K number K061769, which was received on June 23, 2006, and cleared on July 3, 2006. It is classified as a Class 2 device with product code LCX in the Clinical Chemistry specialty.