Cleared Traditional

K861615 - SALICYLATE REAGENT SET

K861615 is the FDA 510(k) clearance for SALICYLATE REAGENT SET by Sterling Diagnostics, Inc.. It is a Class 2 Toxicology device (product code DKJ) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K861615 · Sterling Diagnostics, Inc. · Toxicology device
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May 1986
Decision
24d
Days
Class 2
Risk

K861615 is an FDA 510(k) clearance for the SALICYLATE REAGENT SET. Classified as Colorimetry, Salicylate (product code DKJ), Class II - Special Controls.

Submitted by Sterling Diagnostics, Inc. (Sterling Heights, US). The FDA issued a Cleared decision on May 23, 1986 after a review of 24 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 Sterling Diagnostics, Inc. devices

Submission Details

510(k) Number K861615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1986
Decision Date May 23, 1986
Days to Decision 24 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 87d · This submission: 24d
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 K861615.
EMDS SALICYLATE (SAL) CALIBRATOR, NO# 67641/93
K872321 · Em Diagnostic Systems, Inc. · Aug 1987
EMDS SALICYLATE (SAL) TESTPACKS, ITEM NO. 67694/95
K872330 · Em Diagnostic Systems, Inc. · Jul 1987
SALICYLATE ASSAY KIT, CATALOGUE NUMBER 501-71
K870336 · Diagnostic Chemicals, Ltd. (Usa) · Feb 1987
TDX SALICYLATE
K844070 · Abbott Laboratories · Nov 1984
SALICYLATE ASSAY KIT
K842158 · Diagnostic Chemicals, Ltd. (Usa) · Oct 1984
SALICYLATE TEST
K843180 · Sclavo, Inc. · Sep 1984