Cleared Traditional

K823199 - ENZYME-TEST DIGOXIN

K823199 is the FDA 510(k) clearance for ENZYME-TEST DIGOXIN by Icl Scientific. It is a Class 2 Chemistry device (product code KXT) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K823199 · Icl Scientific · Chemistry device
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Nov 1982
Decision
34d
Days
Class 2
Risk

K823199 is an FDA 510(k) clearance for the ENZYME-TEST DIGOXIN. Classified as Enzyme Immunoassay, Digoxin (product code KXT), Class II - Special Controls.

Submitted by Icl Scientific (Mchenry, US). The FDA issued a Cleared decision on November 29, 1982 after a review of 34 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Icl Scientific devices

Submission Details

510(k) Number K823199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1982
Decision Date November 29, 1982
Days to Decision 34 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
54d faster than avg
Panel avg: 88d · This submission: 34d
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 Chemistry 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 K823199.
SENSIBEAD EIA DIGOXIN KIT
K840673 · Terumo Medical Corp. · Mar 1984
SYVA ADVANCE DIGOXIN ASSAY
K833791 · Syva Co. · Jan 1984
STRATUS DIGOXIN FLUOROMETRIC ENZYME IMM-
K831177 · American Dade · May 1983
ENDAB DIGOXIN KIT
K812054 · Immunotech Corp. · Aug 1981
OREIA-Q-DIG
K802358 · Organon, Inc. · Oct 1980
EMIT AUTO DIGOXIN ASSAY
K790937 · Syva Co. · Jun 1979