Cleared Traditional

SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K020794) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K020794 · Bayer Diagnostics Corp. · Toxicology device
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Jul 2002
Decision
122d
Days
Class 2
Risk

K020794 is an FDA 510(k) clearance for the SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM. Classified as Colorimetry, Salicylate (product code DKJ), Class II - Special Controls.

Submitted by Bayer Diagnostics Corp. (Tarrytown, US). The FDA issued a Cleared decision on July 11, 2002 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3830 - 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 Bayer Diagnostics Corp. devices

Submission Details

510(k) Number K020794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2002
Decision Date July 11, 2002
Days to Decision 122 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 87d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DKJ Colorimetry, Salicylate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3830
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 - DKJ Colorimetry, Salicylate

All 28
Devices cleared under the same product code (DKJ) and FDA review panel - the closest regulatory comparables to K020794.
SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR
K014173 · Beckman Coulter, Inc. · Feb 2002
EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL
K011878 · Syva Co. · Aug 2001
AXSYM SALICYLATE
K951290 · Abbott Laboratories · Aug 1995
ABUSCREEN ONLINE(R) CALIBRATORS
K946000 · Roche Diagnostic Systems, Inc. · Jan 1995
DU PONT DIMENSION(R) SALICYLATE(SAL) METHOD
K904301 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1990
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (SALI)
K902356 · Eastman Kodak Company · Jul 1990