Cleared Traditional

K090282 - QMS LIDOCAINE

K090282 is an FDA 510(k) clearance for QMS LIDOCAINE, manufactured by Thermo Fisher Scientific, Inc.. The device is a Class 2 Toxicology device with product code KLR cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K090282 · Thermo Fisher Scientific, Inc. · Toxicology device
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May 2009
Decision
113d
Days
Class 2
Risk

K090282 is an FDA 510(k) clearance for the QMS LIDOCAINE. Classified as Enzyme Immunoassay, Lidocaine (product code KLR), Class II - Special Controls.

Submitted by Thermo Fisher Scientific, Inc. (Indianapolis, US). The FDA issued a Cleared decision on May 29, 2009 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3555 - 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 Thermo Fisher Scientific, Inc. devices

FDA 510(k) Submission Details - K090282

510(k) Number K090282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2009
Decision Date May 29, 2009
Days to Decision 113 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
26d slower than avg
Panel avg: 87d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLR Device Classification - Class 2, Special Controls

Product Code KLR Enzyme Immunoassay, Lidocaine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3555
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 - KLR Enzyme Immunoassay, Lidocaine

All 15
Devices cleared under the same product code (KLR) and FDA review panel - the closest regulatory comparables to K090282.
DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49D
K033809 · Dade Behring, Inc. · Feb 2004
ROCHE ONLINE TDM LIDOCAINE
K032334 · Roche Diagnostics Corp. · Jan 2004
LIDOCAINE EIA ASSAY
K973102 · Diagnostic Reagents, Inc. · Sep 1997
COBAS REAGENT FOR LIDOCAINE & CALIBRATORS
K853010 · Roche Diagnostic Systems, Inc. · Aug 1985
STRATUS LIDOCAINE FLUOROMETRIC ENZYME
K843184 · American Dade · Sep 1984
LIDOCAINE ANALYTICAL TEST PACK ACA
K833379 · E.I. Dupont DE Nemours & Co., Inc. · Dec 1983