Cleared Traditional

K941255 - CEDIA DIGOXIN PLUS ASSAY

K941255 is an FDA 510(k) clearance for CEDIA DIGOXIN PLUS ASSAY, manufactured by Microgenics Corp.. The device is a Class 2 Toxicology device with product code KXT cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K941255 · Microgenics Corp. · Toxicology device
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Jun 1994
Decision
91d
Days
Class 2
Risk

K941255 is an FDA 510(k) clearance for the CEDIA DIGOXIN PLUS ASSAY. Classified as Enzyme Immunoassay, Digoxin (product code KXT), Class II - Special Controls.

Submitted by Microgenics Corp. (Concord, US). The FDA issued a Cleared decision on June 13, 1994 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3320 - the FDA toxicology 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Microgenics Corp. devices

FDA 510(k) Submission Details - K941255

510(k) Number K941255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1994
Decision Date June 13, 1994
Days to Decision 91 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 87d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KXT Device Classification - Class 2, Special Controls

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 Toxicology devices follow this clearance model.

Regulatory Peers - KXT Enzyme Immunoassay, Digoxin

All 78
Devices cleared under the same product code (KXT) and FDA review panel - the closest regulatory comparables to K941255.
AXSYM DIGOXIN
K944506 · Abbott Laboratories · Dec 1994
EMIT 2000 DIGOXIN ASSAY
K943500 · Syva Co. · Nov 1994
DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET
K940569 · Sigma Diagnostics, Inc. · Jul 1994
ACE CLINICAL CHEMISTRY SYSTEM
K940267 · Schiapparelli Biosystems, Inc. · May 1994
EMIT 2000 DIGOXIN ASSAY/CALIBRATORS MODIFICATION
K934135 · Syva Co. · Apr 1994
CEDIA DIGOXIN PLUS ASSAY
K934168 · Microgenics Corp. · Dec 1993