Cleared Traditional

K081938 - ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30

K081938 is an FDA 510(k) clearance for ACETAMINOPHEN L3K ASSAY, manufactured by Genzyme Diagnostics P.E.I., Inc.. The device is a Class 2 Toxicology device with product code LDP cleared through the Traditional 510(k) pathway after a 297-day FDA review.

K081938 · Genzyme Diagnostics P.E.I., Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
297d
Days
Class 2
Risk

K081938 is an FDA 510(k) clearance for the ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30. Classified as Colorimetry, Acetaminophen (product code LDP), Class II - Special Controls.

Submitted by Genzyme Diagnostics P.E.I., Inc. (Charlottetown, Prin Ed Island, CA). The FDA issued a Cleared decision on May 1, 2009 after a review of 297 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Genzyme Diagnostics P.E.I., Inc. devices

FDA 510(k) Submission Details - K081938

510(k) Number K081938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2008
Decision Date May 01, 2009
Days to Decision 297 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
210d slower than avg
Panel avg: 87d · This submission: 297d
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 32
Devices cleared under the same product code (LDP) and FDA review panel - the closest regulatory comparables to K081938.
SEKURE Acetaminophen L3K Assay
K180835 · Sekisui Diagnostics P.E.I., Inc. · Feb 2019
ROCHE ACETAMINOPHEN ASSAY
K110726 · Roche Diagnostics · Dec 2011
ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138
K100200 · Siemens Healthcare Diagnostics · Aug 2010
DIMENSION VISTA FLEX REAGENT CARTRIDGES
K061655 · Dade Behring, Inc. · Jul 2006
TRIAGE TOX DRUG SCREEN
K043242 · Biosite Incorporated · Feb 2005
ACETAMINOPHEN-SL ASSAY
K042330 · Diagnostic Chemicals , Ltd. · Jan 2005