Cleared Traditional

K893843 - EZ-BEAD DIGOXIN EIA KIT

K893843 is an FDA 510(k) clearance for EZ-BEAD DIGOXIN EIA KIT, manufactured by Immunotech Corp.. The device is a Class 2 Toxicology device with 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

FDA 510(k) Submission Details - K893843

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.

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 K893843.
CEDIA(R) DIGOXIN SC ASSAY
K910642 · Microgenics Corp. · Mar 1991
OPUS(TM) DIGOXIN TEST SYSTEM
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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