Cleared Traditional

SALICYLATE ASSAY KIT (K842158) - FDA 510(k) Clearance

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

K842158 · Diagnostic Chemicals, Ltd. (Usa) · Chemistry device
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Oct 1984
Decision
145d
Days
Class 2
Risk

K842158 is an FDA 510(k) clearance for the SALICYLATE ASSAY KIT. Classified as Colorimetry, Salicylate (product code DKJ), Class II - Special Controls.

Submitted by Diagnostic Chemicals, Ltd. (Usa) (Canada, US). The FDA issued a Cleared decision on October 22, 1984 after a review of 145 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3830 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostic Chemicals, Ltd. (Usa) devices

Submission Details

510(k) Number K842158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1984
Decision Date October 22, 1984
Days to Decision 145 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 88d · This submission: 145d
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 Chemistry 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 K842158.
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