Cleared Traditional

K922353 - DIGOXIN COATED TUBE RIA

K922353 is the FDA 510(k) clearance for DIGOXIN COATED TUBE RIA by Monobind. It is a Class 2 Toxicology device (product code LCS) cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K922353 · Monobind · Toxicology device
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Aug 1992
Decision
97d
Days
Class 2
Risk

K922353 is an FDA 510(k) clearance for the DIGOXIN COATED TUBE RIA. Classified as Radioimmunoassay, Digoxin (125-i) (product code LCS), Class II - Special Controls.

Submitted by Monobind (Costa Mesa, US). The FDA issued a Cleared decision on August 24, 1992 after a review of 97 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.

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Submission Details

510(k) Number K922353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1992
Decision Date August 24, 1992
Days to Decision 97 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 87d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LCS Radioimmunoassay, Digoxin (125-i)
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 - LCS Radioimmunoassay, Digoxin (125-i)

Devices cleared under the same product code (LCS) and FDA review panel - the closest regulatory comparables to K922353.
IMMPULSE DIGOXIN ASSAY REAGENTS
K874748 · Sclavo, Inc. · Feb 1988
DART DIGOXIN ASSAY
K864802 · Coulter Electronics, Inc. · Feb 1987
TDX DIGOXIN
K820154 · Abbott Laboratories · Feb 1982
AMERLEX DIGOXIN RIA KIT
K801413 · Amersham Corp. · Jul 1980
DIGOXIN CLASP RIA KIT
K800997 · E. R. Squibb & Sons, Inc. · May 1980
PHALDEBAS DIGOXIN RIA
K770322 · Pharmacia, Inc. · Apr 1977