Cleared Traditional

K910642 - CEDIA DIGOXIN SC ASSAY

K910642 is the FDA 510(k) clearance for CEDIA DIGOXIN SC ASSAY by Microgenics Corp.. It is a Class 2 Toxicology device (product code KXT) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K910642 · Microgenics Corp. · Toxicology device

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Mar 1991

Decision

36d

Days

Class 2

Risk

K910642 is an FDA 510(k) clearance for the CEDIA(R) DIGOXIN SC ASSAY. 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 21, 1991 after a review of 36 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	K910642 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 13, 1991
Decision Date	March 21, 1991
Days to Decision	36 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

51d faster than avg

Panel avg: 87d · This submission: 36d

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 K910642.

CEDIA DIGOXIN ASSAY (MODIFICATION)

K920214 · Microgenics Corp. · Mar 1992

IL TEST(TM DIGOXIN

K914151 · Instrumentation Laboratory CO · Nov 1991

CEDIA(R) DIGOXIN R' ASSAY

K911941 · Microgenics Corp. · May 1991

OPUS(TM) DIGOXIN TEST SYSTEM

K901547 · Pb Diagnostic Systems, Inc. · Jun 1990

ENZYMUN TEST(R) DIGOXIN

K901216 · Boehringer Mannheim Corp. · May 1990

EZ-BEAD DIGOXIN EIA KIT

K893843 · Immunotech Corp. · Sep 1989

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K910642

Microgenics Corp.

Concord, CA · US

Patricia M Klimley

Regulatory profile

107 submissions 106 cleared

99% clearance rate · Active in Toxicology

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Sourced from FDA 510(k) public files . Updated monthly.

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