Cleared Traditional

K893843 - EZ-BEAD DIGOXIN EIA KIT

K893843 is the FDA 510(k) clearance for EZ-BEAD DIGOXIN EIA KIT by Immunotech Corp.. It is a Class 2 Toxicology device (product code KXT) cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K893843 · Immunotech Corp. · Toxicology device
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Sep 1989
Decision
126d
Days
Class 2
Risk

K893843 is an FDA 510(k) clearance for the EZ-BEAD DIGOXIN EIA KIT. Classified as Enzyme Immunoassay, Digoxin (product code KXT), Class II - Special Controls.

Submitted by Immunotech Corp. (Boston, US). The FDA issued a Cleared decision on September 28, 1989 after a review of 126 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 Immunotech Corp. devices

Submission Details

510(k) Number K893843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1989
Decision Date September 28, 1989
Days to Decision 126 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 87d · This submission: 126d
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 Toxicology 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 K893843.
CEDIA(R) DIGOXIN SC ASSAY
K910642 · Microgenics Corp. · Mar 1991
OPUS(TM) DIGOXIN TEST SYSTEM
K901547 · Pb Diagnostic Systems, Inc. · Jun 1990
ENZYMUN TEST(R) DIGOXIN
K901216 · Boehringer Mannheim Corp. · May 1990
EMIT CONVENIENCE PACK: DIGOXIN ASSAY
K893910 · Syva Co. · Aug 1989
SERALYZER DIGOXIN ASSAY/TEST MOD/CALIB/CONTR/AMES
K884528 · Heraeus Kulzer, Inc. · Mar 1989
MODIFICATION OF THE CEDIA DIGOXIN ASSAY
K884054 · Microgenics Corp. · Dec 1988