Cleared Traditional

AXSYM ACETAMINOPHEN (K953094) - FDA 510(k) Clearance

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

K953094 · Abbott Laboratories · Toxicology device
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Optimized for regulatory review, auditing and printing
Aug 1995
Decision
52d
Days
Class 2
Risk

K953094 is an FDA 510(k) clearance for the AXSYM ACETAMINOPHEN. Classified as Colorimetry, Acetaminophen (product code LDP), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 24, 1995 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3030 - 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 Abbott Laboratories devices

Submission Details

510(k) Number K953094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1995
Decision Date August 24, 1995
Days to Decision 52 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
35d faster than avg
Panel avg: 87d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDP Colorimetry, Acetaminophen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3030
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 - LDP Colorimetry, Acetaminophen

All 15
Devices cleared under the same product code (LDP) and FDA review panel - the closest regulatory comparables to K953094.
EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL
K002974 · Dade Behring, Inc. · Oct 2000
SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT
K000494 · Beckman Coulter, Inc. · Apr 2000
COBAS INTEGRA ACETAMINOPHEN
K991598 · Roche Diagnostics Corp. · Jul 1999
EASY-TEST EMIT ACETAMINOPHEN (ACTM) NO. 16653
K882719 · Em Diagnostic Systems, Inc. · Aug 1988
EMIT QST ACETAMINOPHEN ASSAY
K844962 · Syva Co. · Jan 1985
ACA ACETAMINOPHEN ANALYTICAL TEST PACK
K842548 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1984