Cleared Traditional

K842158 - SALICYLATE ASSAY KIT

K842158 is the FDA 510(k) clearance for SALICYLATE ASSAY KIT by Diagnostic Chemicals, Ltd. (Usa). It is a Class 2 Chemistry device (product code DKJ) cleared through the Traditional 510(k) pathway after a 145-day FDA review.

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
Combination Product No
PCCP Authorized No
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 22
Devices cleared under the same product code (DKJ) and FDA review panel - the closest regulatory comparables to K842158.
SALICYLATE ASSAY KIT, CATALOGUE NUMBER 501-71
K870336 · Diagnostic Chemicals, Ltd. (Usa) · Feb 1987
SALICYLATE REAGENT SET
K861615 · Sterling Diagnostics, Inc. · May 1986
TDX SALICYLATE
K844070 · Abbott Laboratories · Nov 1984
SALICYLATE TEST
K843180 · Sclavo, Inc. · Sep 1984
DETERMIN. OF SALICYLATE IN SERUM/PLAST
K840243 · Sigma Chemical Co. · Mar 1984
PARAMAX SALICYLATE REAGENT
K833003 · American Dade · Oct 1983