Cleared Traditional

K981059 - ACETAMINOPHEN-SL ASSAY

K981059 is the FDA 510(k) clearance for ACETAMINOPHEN-SL ASSAY by Diagnostic Chemicals , Ltd.. It is a Class 2 Toxicology device (product code LDP) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K981059 · Diagnostic Chemicals , Ltd. · Toxicology device
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May 1998
Decision
50d
Days
Class 2
Risk

K981059 is an FDA 510(k) clearance for the ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30.. Classified as Colorimetry, Acetaminophen (product code LDP), Class II - Special Controls.

Submitted by Diagnostic Chemicals , Ltd. (Charlottestown,Pei,Canada, CA). The FDA issued a Cleared decision on May 12, 1998 after a review of 50 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 Diagnostic Chemicals , Ltd. devices

Submission Details

510(k) Number K981059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1998
Decision Date May 12, 1998
Days to Decision 50 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 87d · This submission: 50d
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 27
Devices cleared under the same product code (LDP) and FDA review panel - the closest regulatory comparables to K981059.
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
ACETAMINOPHEN ASSAY (ACE), CATALOGUE NUMBER 503-10
K980031 · Diagnostic Chemicals , Ltd. · Mar 1998
ACETAMINOPHEN SERUM TOX EIA ASSAY
K961373 · Diagnostic Reagents, Inc. · Jul 1996
ACETAMINOPHEN ASSAY
K952949 · Diagnostic Chemicals , Ltd. · Sep 1995