Cleared Traditional

K920214 - CEDIA DIGOXIN ASSAY (MODIFICATION)

K920214 is the FDA 510(k) clearance for CEDIA DIGOXIN ASSAY (MODIFICATION) by Microgenics Corp.. It is a Class 2 Toxicology device (product code KXT) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K920214 · Microgenics Corp. · Toxicology device
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Mar 1992
Decision
46d
Days
Class 2
Risk

K920214 is an FDA 510(k) clearance for the CEDIA DIGOXIN ASSAY (MODIFICATION). 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 2, 1992 after a review of 46 days - a notably fast clearance cycle.

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: 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 Microgenics Corp. devices

Submission Details

510(k) Number K920214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1992
Decision Date March 02, 1992
Days to Decision 46 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 87d · This submission: 46d
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 K920214.
ACA DIGOXIN ANALYTICAL TEST PACK
K930162 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1993
ACCESS DIGOXIN ASSAY
K925802 · Bio-Rad Laboratories, Inc. · Jan 1993
CEDIA DIGOXIN PLUS ASSAY
K923853 · Microgenics Corp. · Sep 1992
IL TEST(TM DIGOXIN
K914151 · Instrumentation Laboratory CO · Nov 1991
CEDIA(R) DIGOXIN R' ASSAY
K911941 · Microgenics Corp. · May 1991
CEDIA(R) DIGOXIN SC ASSAY
K910642 · Microgenics Corp. · Mar 1991