Cleared Traditional

QMS LIDOCAINE (K090282) - FDA 510(k) Clearance

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

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

Submission Details

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.

Device Classification

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 16
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
COBAS REAGENT FOR LIDOCAINE & CALIBRATORS
K853010 · Roche Diagnostic Systems, Inc. · Aug 1985
MODIF. OF EMIT CAD DISOPYRAMIDE ASSAY
K833623 · Syva Co. · Dec 1983
MODIFICA- OF EMIT CAD LIDOCAINE ASSAY
K832799 · Syva Co. · Oct 1983
EMIT QST LIDOCAINE ASSAY
K831354 · Syva Co. · May 1983
ADVANCE EMIT CAD DISOPYRAMIDE ASSAY
K823887 · Syva Co. · Jan 1983