Cleared Traditional

ACETAMINOPHEN ASSAY (ACE), CATALOGUE NUMBER 503-10 (K980031) - FDA 510(k) Clearance

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

K980031 · Diagnostic Chemicals , Ltd. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
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 35
Devices cleared under the same product code (LDP) and FDA review panel - the closest regulatory comparables to K980031.
Acetaminophen
K202644 · Sekisui Diagnostics P.E.I., Inc. · Feb 2022
SEKURE Acetaminophen L3K Assay
K180835 · Sekisui Diagnostics P.E.I., Inc. · Feb 2019
DIMENSION VISTA FLEX REAGENT CARTRIDGES
K061655 · Dade Behring, Inc. · Jul 2006
ROCHE ACETAMINOPHEN
K013757 · Roche Diagnostics Corp. · Jan 2002
SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO
K011465 · Beckman Coulter, Inc. · Jun 2001
EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL
K002974 · Dade Behring, Inc. · Oct 2000