Sopheia/MP Digitoxin EIA Kit

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K842578 ↗

FDA Product Code

LFM

Device Class

Class II

Regulation

21 CFR Part 862.3300

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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• What clinical area is the Sopheia/MP Digitoxin EIA Kit primarily used for, and why is this important for laboratories?

  The Sopheia/MP Digitoxin EIA Kit is designed for clinical toxicology evaluations, specifically to measure digitoxin levels in biological samples. This is critical for assessing cardiac glycoside toxicity, helping clinicians monitor patients who may have ingested or been prescribed digitoxin—commonly used to treat heart conditions like atrial fibrillation or heart failure. Since digitoxin toxicity can lead to serious complications like arrhythmias or renal issues, accurate measurement supports informed treatment decisions.

• Is this kit intended for single-use or repeated testing, and how does that affect workflow in a clinical lab?

  The kit is explicitly labeled as a single-use diagnostic reagent, meaning each kit is intended for one testing cycle only. This design ensures consistency and reliability in results, as reuse could introduce contamination or variability. For labs, this means each test requires a fresh kit, which may impact inventory management and workflow planning, particularly in high-volume settings where multiple digitoxin measurements are needed.

• What regulatory pathway does the Sopheia/MP Digitoxin EIA Kit follow, and what does that mean for its use in a lab?

  The kit follows the FDA 510(k) clearance pathway, with a decision code of *SESE* (Substantially Equivalent) under the traditional review process. This classification means the device was determined to be comparable to a legally marketed predicate device in terms of technology and safety. For labs, this indicates the kit has undergone FDA review for its intended use in toxicology assays, providing confidence in its compliance with U.S. regulatory standards for diagnostic accuracy and performance.

• Are there multiple versions or sizes of this kit, and if so, how might that affect testing flexibility?

  The data includes multiple FEI numbers (e.g., 3012963943, 3010825766), which typically correspond to different lot or variant identifiers in FDA records. While these don’t explicitly describe