Cleared Traditional

DETERMIN. OF SALICYLATE IN SERUM/PLAST (K840243) - FDA 510(k) Clearance

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

K840243 · Sigma Chemical Co. · Chemistry device
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Mar 1984
Decision
63d
Days
Class 2
Risk

K840243 is an FDA 510(k) clearance for the DETERMIN. OF SALICYLATE IN SERUM/PLAST. Classified as Colorimetry, Salicylate (product code DKJ), Class II - Special Controls.

Submitted by Sigma Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on March 23, 1984 after a review of 63 days - a notably fast clearance cycle.

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: 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 Sigma Chemical Co. devices

Submission Details

510(k) Number K840243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1984
Decision Date March 23, 1984
Days to Decision 63 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
25d faster than avg
Panel avg: 88d · This submission: 63d
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 K840243.
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