Epsilon Digoxin Test Kit

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K842655 ↗

FDA Product Code

KXT

Device Class

Class II

Regulation

21 CFR Part 862.3320

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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See all devices from Beckman Instruments, Inc. →

• What is the Epsilon Digoxin Test Kit used for?

  The Epsilon Digoxin Test Kit is an enzyme immunoassay device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.

• How is the Epsilon Digoxin Test Kit supplied and what is its classification?

  The device is supplied as a test kit and is classified as a Class II medical device under FDA regulation number 862.3320. It received traditional 510(k) clearance (K842655) on August 16, 1984, following a 37-day review, and is substantially equivalent to a legally marketed predicate device.

• What regulatory pathway was used for the Epsilon Digoxin Test Kit and what was the outcome?

  The Epsilon Digoxin Test Kit received traditional 510(k) clearance (K842655) on August 16, 1984, following a 37-day review. The decision code was SESE, indicating it was found substantially equivalent to a legally marketed predicate device under FDA regulation 862.3320.