Cleared Traditional

K942619 - EMIT 2000 DIGOXIN ASSAY/CALIBRATORS

K942619 is an FDA 510(k) clearance for EMIT 2000 DIGOXIN ASSAY/CALIBRATORS, manufactured by Syva Co.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K942619

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.

LFM Device Classification - Class 2, Special Controls

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 17
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