Leap Mono Test Kit

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K840822 ↗

FDA Product Code

KTN

Device Class

Class II

Regulation

21 CFR Part 866.5640

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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See all devices from Cooper Biomedical, Inc. →

• What is the LEAP MONO TEST KIT used for?

  The LEAP MONO TEST KIT is an immunological test system designed to measure heterophile antibodies in serum, plasma, and other body fluids using immunochemical techniques. These antibodies are frequently associated with infectious mononucleosis, and their measurement aids in the diagnosis of the condition by detecting an immune response linked to Epstein-Barr virus infection.

• How is the LEAP MONO TEST KIT supplied and what are its components?

  The LEAP MONO TEST KIT is supplied as a complete test system containing the reagents necessary to perform immunochemical measurements of heterophile antibodies. It includes all required components for conducting the assay, such as antigens, controls, and reaction buffers, enabling laboratories to run the test according to the manufacturer's protocol for accurate detection of mononucleosis-related antibodies.

• Is the LEAP MONO TEST KIT intended for single-use or repeated use?

  The LEAP MONO TEST KIT is intended for single-use per test procedure. Each kit provides reagents for a defined number of tests, and components are not designed to be reused after initial use due to potential degradation, contamination risks, and loss of reagent stability, which could compromise test accuracy and reliability.

• What regulatory pathway was used for the LEAP MONO TEST KIT and when was it cleared?

  The LEAP MONO TEST KIT received FDA 510(k) clearance through a traditional submission on April 5, 1984, under K number K840822. It was found substantially equivalent to a predicate device and classified as a Class II medical device under product code KTN and regulation 866.5640, which governs infectious mononucleosis test systems.

• What storage conditions are recommended for the LEAP MONO TEST KIT?

  While the device data does not specify exact storage conditions, immunological test kits like the LEAP MONO TEST KIT typically require refrigerated storage (2–8°C) to maintain reagent stability and antibody activity. Users should follow the manufacturer’s labeling instructions, which would have been provided with the kit, to ensure proper performance and shelf life until the expiration date.