Discover Pregnancy Test Kit

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Discover(R)

510(k) Number

K882232 ↗

FDA Product Code

LCX

Device Class

Class II

Regulation

21 CFR Part 862.1155

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the Discover Pregnancy Test Kit used for and how does it work?

  The Discover Pregnancy Test Kit is a home-use diagnostic device designed to detect the presence of human chorionic gonadotropin (hCG) in urine, which is a hormone produced during pregnancy. It provides a qualitative result—either confirming or ruling out early pregnancy—by analyzing a urine sample. This over-the-counter test is intended for single-use and does not require any special medical training to administer.

• Is the Discover Pregnancy Test Kit reusable, or is it meant for one-time use?

  The Discover Pregnancy Test Kit is explicitly designed for single-use only. It is not intended for reuse or reprocessing, as this could compromise its accuracy and reliability. Each kit is supplied ready-to-use, ensuring a fresh and sterile test for each use.

• What storage conditions are required for the Discover Pregnancy Test Kit?

  The Discover Pregnancy Test Kit does not require any special storage conditions beyond keeping it at room temperature. This makes it convenient for home use, as no refrigeration or controlled environment is necessary before or after purchase.

• How is the regulatory approval process for the Discover Pregnancy Test Kit structured?

  The Discover Pregnancy Test Kit holds FDA 510K clearance (K882232), which means it was determined to be *substantially equivalent* to a legally marketed device in its category. The submission was reviewed under the Clinical Chemistry advisory committee (CH) and falls under the product code LCX. This clearance ensures it meets regulatory standards for diagnostic accuracy and safety as an over-the-counter pregnancy test.