Cleared Traditional

VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND III (K043386) - FDA 510(k) Clearance

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

K043386 · Ortho-Clinical Diagnostics, Inc. · Toxicology device
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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

Submission Details

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
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.

Device Classification

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 30
Devices cleared under the same product code (LEH) and FDA review panel - the closest regulatory comparables to K043386.
Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)
K222439 · Siemens Healthcare Diagnostics, Inc. · Aug 2023
Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)
K160202 · Siemens Healthcare Diagnostics, Inc. · Apr 2016
IMMULITE 2000, IMMULITE 2500 VANCOMYCIN
K063045 · Diagnostic Products Corp. · Dec 2006
ENZYME IMMUNOASSAY, VANCOMYCIN
K060586 · Roche Diagnostics Corp. · May 2006
EMIT 2000 VANCOMYCIN ASSAY
K020692 · Dade Behring, Inc. · May 2002
SYNCHRON SYSTEMS VANCOMYCIN REAGENT
K013076 · Beckman Coulter, Inc. · Dec 2001