Cleared Traditional

K842158 - SALICYLATE ASSAY KIT

K842158 is an FDA 510(k) clearance for SALICYLATE ASSAY KIT, manufactured by Diagnostic Chemicals, Ltd. (Usa). The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K842158

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.

DKJ Device Classification - Class 2, Special Controls

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 26
Devices cleared under the same product code (DKJ) and FDA review panel - the closest regulatory comparables to K842158.
SALICYLATE REAGENT SET
K861615 · Sterling Diagnostics, Inc. · May 1986
GGTP REAGENT/SERUM IRON/SALICYLATE DEMAND ANALYZER
K852027 · Advanced Biomedical Methods, Inc. · May 1985
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