Cleared Traditional

K043386 - VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND III

K043386 is an FDA 510(k) clearance for VITROS CHEMISTRY PRODUCTS VANC REAGENT, manufactured by Ortho-Clinical Diagnostics, Inc.. The device is a Class 2 Toxicology device with product code LEH cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K043386 · Ortho-Clinical Diagnostics, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
60d
Days
Class 2
Risk

K043386 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE.... Classified as Radioimmunoassay, Vancomycin (product code LEH), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on February 7, 2005 after a review of 60 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 Ortho-Clinical Diagnostics, Inc. devices

FDA 510(k) Submission Details - K043386

510(k) Number K043386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2004
Decision Date February 07, 2005
Days to Decision 60 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
27d faster than avg
Panel avg: 87d · This submission: 60d
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 K043386.
IMMULITE 2000, IMMULITE 2500 VANCOMYCIN
K063045 · Diagnostic Products Corp. · Dec 2006
ENZYME IMMUNOASSAY, VANCOMYCIN
K060586 · Roche Diagnostics Corp. · May 2006
QMS VANCOMYCIN
K050419 · Seradyn, Inc. · Apr 2005
CEDIA VANCOMYCIN ASSAY
K032811 · Microgenics Corp. · Nov 2003
EMIT 2000 VANCOMYCIN ASSAY
K020692 · Dade Behring, Inc. · May 2002
SYNCHRON SYSTEMS VANCOMYCIN REAGENT
K013076 · Beckman Coulter, Inc. · Dec 2001