Cleared Traditional

K942619 - EMIT 2000 DIGOXIN ASSAY/CALIBRATORS

K942619 is the FDA 510(k) clearance for EMIT 2000 DIGOXIN ASSAY/CALIBRATORS by Syva Co.. It is a Class 2 Chemistry device (product code LFM) cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K942619 · Syva Co. · Chemistry device
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Sep 1994
Decision
117d
Days
Class 2
Risk

K942619 is an FDA 510(k) clearance for the EMIT 2000 DIGOXIN ASSAY/CALIBRATORS. Classified as Enzyme Immunoassay, Digitoxin (product code LFM), Class II - Special Controls.

Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on September 20, 1994 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3300 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Syva Co. devices

Submission Details

510(k) Number K942619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1994
Decision Date September 20, 1994
Days to Decision 117 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 88d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LFM Enzyme Immunoassay, Digitoxin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3300
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 Chemistry devices follow this clearance model.

Regulatory Peers - LFM Enzyme Immunoassay, Digitoxin

All 16
Devices cleared under the same product code (LFM) and FDA review panel - the closest regulatory comparables to K942619.
DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS
K951631 · Bayer Corp. · Jun 1995
IMMULITE DIGITOXIN
K943235 · Diagnostic Products Corp. · Oct 1994
KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN)
K942610 · Eastman Kodak Company · Oct 1994
DIGITOXIN FPIA REAGENT SET
K915465 · Sigma Diagnostics, Inc. · Jan 1992
MILENIA (TM) DIGITOXIN
K900013 · Diagnostic Products Corp. · Mar 1990
CEDIA DIGITOXIN ASSAY
K896021 · Microgenics Corp. · Nov 1989