Cleared Traditional

K980031 - ACETAMINOPHEN ASSAY (ACE)

K980031 is the FDA 510(k) clearance for ACETAMINOPHEN ASSAY (ACE) by Diagnostic Chemicals , Ltd.. It is a Class 2 Toxicology device (product code LDP) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K980031 · Diagnostic Chemicals , Ltd. · Toxicology device
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Mar 1998
Decision
57d
Days
Class 2
Risk

K980031 is an FDA 510(k) clearance for the ACETAMINOPHEN ASSAY (ACE), CATALOGUE NUMBER 503-10. Classified as Colorimetry, Acetaminophen (product code LDP), Class II - Special Controls.

Submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E.I., CA). The FDA issued a Cleared decision on March 3, 1998 after a review of 57 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 K980031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1998
Decision Date March 03, 1998
Days to Decision 57 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
30d faster than avg
Panel avg: 87d · This submission: 57d
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 K980031.
SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT
K000494 · Beckman Coulter, Inc. · Apr 2000
COBAS INTEGRA ACETAMINOPHEN
K991598 · Roche Diagnostics Corp. · Jul 1999
ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30.
K981059 · Diagnostic Chemicals , Ltd. · May 1998
ACETAMINOPHEN SERUM TOX EIA ASSAY
K961373 · Diagnostic Reagents, Inc. · Jul 1996
ACETAMINOPHEN ASSAY
K952949 · Diagnostic Chemicals , Ltd. · Sep 1995
AXSYM ACETAMINOPHEN
K953094 · Abbott Laboratories · Aug 1995