Cleared Traditional

K020794 - SALICYLATE ASSAY FOR THE ADVIA INTEGRAT...

K020794 is the FDA 510(k) clearance for SALICYLATE ASSAY FOR THE ADVIA INTEGRAT... by Bayer Diagnostics Corp.. It is a Class 2 Toxicology device (product code DKJ) cleared through the Traditional 510(k) pathway after a 122-day FDA review.

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 23
Devices cleared under the same product code (DKJ) and FDA review panel - the closest regulatory comparables to K020794.
ADVIA CHEMISTRY SALICYLATE REAGENT
K093939 · Siemens Healthcare Diagnostics · May 2010
SALICYLATE-SL ASSAY
K042329 · Diagnostic Chemicals , Ltd. · Dec 2004
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
SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40
K981872 · Diagnostic Chemicals , Ltd. · Jun 1998
SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71
K980032 · Diagnostic Chemicals , Ltd. · Mar 1998