Cleared Traditional

K951290 - AXSYM SALICYLATE

K951290 is an FDA 510(k) clearance for AXSYM SALICYLATE, manufactured by Abbott Laboratories. The device is a Class 2 Toxicology device with product code DKJ cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K951290 · Abbott Laboratories · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
140d
Days
Class 2
Risk

K951290 is an FDA 510(k) clearance for the AXSYM SALICYLATE. Classified as Colorimetry, Salicylate (product code DKJ), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 8, 1995 after a review of 140 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K951290

510(k) Number K951290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1995
Decision Date August 08, 1995
Days to Decision 140 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 87d · This submission: 140d
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 Toxicology devices follow this clearance model.

Regulatory Peers - DKJ Colorimetry, Salicylate

All 24
Devices cleared under the same product code (DKJ) and FDA review panel - the closest regulatory comparables to K951290.
SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71
K980032 · Diagnostic Chemicals , Ltd. · Mar 1998
PARAMAX SALICYLATE REAGENT
K964715 · Dade Intl., Inc. · Apr 1997
SALICYLATE ASSAY
K961131 · Diagnostic Reagents, Inc. · Apr 1996
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