Cleared Traditional

K932250 - VIDAS DIGOXIN (DIG)

K932250 is the FDA 510(k) clearance for VIDAS DIGOXIN (DIG) by Biomerieux Vitek, Inc.. It is a Class 2 General & Plastic Surgery device (product code KXT) cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K932250 · Biomerieux Vitek, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
Combination Product No
PCCP Authorized No
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 69
Devices cleared under the same product code (KXT) and FDA review panel - the closest regulatory comparables to K932250.
CEDIA DIGOXIN PLUS ASSAY
K941255 · Microgenics Corp. · Jun 1994
EMIT 2000 DIGOXIN ASSAY/CALIBRATORS MODIFICATION
K934135 · Syva Co. · Apr 1994
CEDIA DIGOXIN PLUS ASSAY
K934168 · Microgenics Corp. · Dec 1993
DIGOXIN TEST SYSTEM, KXT TX
K931123 · Syva Co. · Aug 1993
ACS DIGOXIN IMMUNOASSAY
K931213 · Ciba Corning Diagnostics Corp. · Jun 1993
ACA DIGOXIN ANALYTICAL TEST PACK
K930162 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1993