Cleared Traditional

K854638 - CEDIA DIGOXIN ASSAY

K854638 is an FDA 510(k) clearance for CEDIA DIGOXIN ASSAY, manufactured by Microgenics Corp.. The device is a Class 2 Chemistry device with product code KXT cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K854638 · Microgenics Corp. · Chemistry device
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Mar 1986
Decision
126d
Days
Class 2
Risk

K854638 is an FDA 510(k) clearance for the CEDIA DIGOXIN 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 March 25, 1986 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3320 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Microgenics Corp. devices

FDA 510(k) Submission Details - K854638

510(k) Number K854638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1985
Decision Date March 25, 1986
Days to Decision 126 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 88d · This submission: 126d
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 Chemistry 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 K854638.
DELFIA DIGOXIN
K861195 · Lkb Instruments, Inc. · Jul 1986
EMIT COLUMN DIGOXIN ASSAY
K861393 · Syva Co. · May 1986
EMIT DIGOXIN MOBILE PHASE SOLUTION
K861394 · Syva Co. · May 1986
V-TREND DIG ENZYME IMMUNOASSAY TEST KIT
K854972 · V-Tech, Inc. · Jan 1986
COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C
K851032 · Roche Diagnostic Systems, Inc. · Apr 1985
DUPONT DIGOXIN ASSAY REAGENTS
K850458 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1985