Cleared Traditional

K032811 - CEDIA VANCOMYCIN ASSAY

K032811 is an FDA 510(k) clearance for CEDIA VANCOMYCIN ASSAY, manufactured by Microgenics Corp.. The device is a Class 2 Toxicology device with product code LEH cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K032811 · Microgenics Corp. · Toxicology device
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Nov 2003
Decision
76d
Days
Class 2
Risk

K032811 is an FDA 510(k) clearance for the CEDIA VANCOMYCIN ASSAY. Classified as Radioimmunoassay, Vancomycin (product code LEH), Class II - Special Controls.

Submitted by Microgenics Corp. (Fremont Blvd., US). The FDA issued a Cleared decision on November 24, 2003 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3950 - 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 Microgenics Corp. devices

FDA 510(k) Submission Details - K032811

510(k) Number K032811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2003
Decision Date November 24, 2003
Days to Decision 76 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 87d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LEH Device Classification - Class 2, Special Controls

Product Code LEH Radioimmunoassay, Vancomycin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3950
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 - LEH Radioimmunoassay, Vancomycin

All 29
Devices cleared under the same product code (LEH) and FDA review panel - the closest regulatory comparables to K032811.
ENZYME IMMUNOASSAY, VANCOMYCIN
K060586 · Roche Diagnostics Corp. · May 2006
QMS VANCOMYCIN
K050419 · Seradyn, Inc. · Apr 2005
VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND III
K043386 · Ortho-Clinical Diagnostics, Inc. · Feb 2005
EMIT 2000 VANCOMYCIN ASSAY
K020692 · Dade Behring, Inc. · May 2002
SYNCHRON SYSTEMS VANCOMYCIN REAGENT
K013076 · Beckman Coulter, Inc. · Dec 2001
VANCOMYCIN EIA ASSAY
K983280 · Diagnostic Reagents, Inc. · Nov 1998