Cleared Traditional

K980032 - SALICYLATE ASSAY (ACE)

K980032 is the FDA 510(k) clearance for SALICYLATE ASSAY (ACE) by Diagnostic Chemicals , Ltd.. It is a Class 2 Toxicology device (product code DKJ) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K980032 · Diagnostic Chemicals , Ltd. · Toxicology device
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Mar 1998
Decision
56d
Days
Class 2
Risk

K980032 is an FDA 510(k) clearance for the SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71. Classified as Colorimetry, Salicylate (product code DKJ), Class II - Special Controls.

Submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E.I., CA). The FDA issued a Cleared decision on March 2, 1998 after a review of 56 days - a notably fast clearance cycle.

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: 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 Diagnostic Chemicals , Ltd. devices

Submission Details

510(k) Number K980032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1998
Decision Date March 02, 1998
Days to Decision 56 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 87d · This submission: 56d
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 22
Devices cleared under the same product code (DKJ) and FDA review panel - the closest regulatory comparables to K980032.
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
K961131 · Diagnostic Reagents, Inc. · Apr 1996
AXSYM SALICYLATE
K951290 · Abbott Laboratories · Aug 1995
ABUSCREEN ONLINE(R) CALIBRATORS
K946000 · Roche Diagnostic Systems, Inc. · Jan 1995