Cleared Traditional

VIDAS DIGOXIN (DIG) (K932250) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K932250 · Biomerieux Vitek, Inc. · General & Plastic Surgery device
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Sep 1993
Decision
123d
Days
Class 2
Risk

K932250 is an FDA 510(k) clearance for the VIDAS DIGOXIN (DIG). Classified as Enzyme Immunoassay, Digoxin (product code KXT), Class II - Special Controls.

Submitted by Biomerieux Vitek, Inc. (Rockland, US). The FDA issued a Cleared decision on September 10, 1993 after a review of 123 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 862.3320 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Biomerieux Vitek, Inc. devices

Submission Details

510(k) Number K932250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1993
Decision Date September 10, 1993
Days to Decision 123 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 115d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KXT Enzyme Immunoassay, Digoxin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3320
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - KXT Enzyme Immunoassay, Digoxin

All 84
Devices cleared under the same product code (KXT) and FDA review panel - the closest regulatory comparables to K932250.
ADVIA Centaur® Digoxin assay
K193397 · Siemens Healthcare Diagnostics, Inc. · Jul 2021
AXSYM DIGOXIN III
K061249 · Abbott Laboratories · Jun 2006
IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS)
K012301 · Diagnostic Products Corp. · Sep 2001
IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT
K983151 · Beckman Coulter, Inc. · Nov 1998
SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOR
K982935 · Beckman Coulter, Inc. · Oct 1998
ELECSYS DIGOXIN
K973112 · Boehringer Mannheim Corp. · Oct 1997