Cleared Traditional

K951755 - EMIT 2000 DIGOXIN ASSAY

K951755 is the FDA 510(k) clearance for EMIT 2000 DIGOXIN ASSAY by Syva Co.. It is a Class 2 Chemistry device (product code KXT) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K951755 · Syva Co. · Chemistry device
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Jun 1995
Decision
45d
Days
Class 2
Risk

K951755 is an FDA 510(k) clearance for the EMIT 2000 DIGOXIN ASSAY. 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 June 1, 1995 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3320 - 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: 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 Syva Co. devices

Submission Details

510(k) Number K951755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1995
Decision Date June 01, 1995
Days to Decision 45 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 88d · This submission: 45d
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 Chemistry devices follow this clearance model.

Regulatory Peers - KXT Enzyme Immunoassay, Digoxin

All 64
Devices cleared under the same product code (KXT) and FDA review panel - the closest regulatory comparables to K951755.
IMX DIGOXIN
K952079 · Abbott Laboratories · Jul 1995
IL TEST DIGOXIN, PN 181761-00
K951391 · Instrumentation Laboratory CO · Jun 1995
DUPONT ACA DIGOXIN (DGN A) METHOD
K951441 · E.I. Dupont DE Nemours & Co., Inc. · Jun 1995
IL TEST DIGOXIN & IL TEST DIGOXIN CALIBRATORS
K943983 · Instrumentation Laboratory CO · Apr 1995
DIGOXIN FLEX(TM) REAGENT CARTRIDGE
K946153 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1995
AXSYM DIGOXIN
K944506 · Abbott Laboratories · Dec 1994