Innofluor Digoxin Reagent Set

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K895828 ↗

FDA Product Code

LCS

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 Innotron of Oregon, Inc. →

• What is the Innofluor Digoxin Reagent Set used for?

  The Innofluor Digoxin Reagent Set is used for the measurement of digoxin in clinical specimens via radioimmunoassay, employing iodine-125 as a radioactive label, and is intended for in vitro diagnostic use in laboratory settings by qualified personnel.

• How is the Innofluor Digoxin Reagent Set supplied and what is its intended use?

  The device is supplied as a reagent set for in vitro diagnostic use, specifically designed for measuring digoxin levels in clinical specimens using a radioimmunoassay method with iodine-125 labeling, and is intended for use in laboratory environments by trained personnel.

• Is the Innofluor Digoxin Reagent Set sterile or single-use?

  The device data does not specify whether the Innofluor Digoxin Reagent Set is sterile or single-use; it is described only as a reagent set for in vitro diagnostic use, so sterility and reuse characteristics are not provided in the available information.

• What regulatory pathway was used for the Innofluor Digoxin Reagent Set?

  The Innofluor Digoxin Reagent Set received traditional 510(k) clearance from the FDA under submission K895828, indicating it was found substantially equivalent to a legally marketed predicate device, as noted in its decision description and clearance type.