Cleared Traditional

K934135 - EMIT 2000 DIGOXIN ASSAY/CALIBRATORS MOD...

K934135 is the FDA 510(k) clearance for EMIT 2000 DIGOXIN ASSAY/CALIBRATORS MOD... by Syva Co.. It is a Class 2 Toxicology device (product code KXT) cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K934135 · Syva Co. · Toxicology device
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Apr 1994
Decision
224d
Days
Class 2
Risk

K934135 is an FDA 510(k) clearance for the EMIT 2000 DIGOXIN ASSAY/CALIBRATORS MODIFICATION. Classified as Enzyme Immunoassay, Digoxin (product code KXT), Class II - Special Controls.

Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on April 6, 1994 after a review of 224 days - an extended review 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: 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.

View all Syva Co. devices

Submission Details

510(k) Number K934135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1993
Decision Date April 06, 1994
Days to Decision 224 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 87d · This submission: 224d
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 K934135.
EMIT 2000 DIGOXIN ASSAY
K943500 · Syva Co. · Nov 1994
DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET
K940569 · Sigma Diagnostics, Inc. · Jul 1994
CEDIA DIGOXIN PLUS ASSAY
K941255 · Microgenics Corp. · Jun 1994
CEDIA DIGOXIN PLUS ASSAY
K934168 · Microgenics Corp. · Dec 1993
VIDAS DIGOXIN (DIG)
K932250 · Biomerieux Vitek, Inc. · Sep 1993
DIGOXIN TEST SYSTEM, KXT TX
K931123 · Syva Co. · Aug 1993