Cleared Traditional

K953094 - AXSYM ACETAMINOPHEN

K953094 is an FDA 510(k) clearance for AXSYM ACETAMINOPHEN, manufactured by Abbott Laboratories. The device is a Class 2 Toxicology device with product code LDP cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K953094 · Abbott Laboratories · Toxicology device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K953094

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.

LDP Device Classification - Class 2, Special Controls

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 30
Devices cleared under the same product code (LDP) and FDA review panel - the closest regulatory comparables to K953094.
ACETAMINOPHEN SERUM TOX EIA ASSAY
K961373 · Diagnostic Reagents, Inc. · Jul 1996
EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN
K954933 · Johnson & Johnson Clinical Diagnostics, Inc. · Dec 1995
ACETAMINOPHEN ASSAY
K952949 · Diagnostic Chemicals , Ltd. · Sep 1995
ACETAMINOPHEN (ENZYMATIC RATE), NUMBER 502-13
K885097 · Diagnostic Chemicals, Ltd. (Usa) · Jan 1989
EASY-TEST EMIT ACETAMINOPHEN (ACTM) NO. 16653
K882719 · Em Diagnostic Systems, Inc. · Aug 1988
ACETAZYME, STANBIO ACETAMINOPHEN PROC/TEST 0870
K851278 · Stanbio Laboratory · Apr 1985