Cleared Traditional

K063045 - IMMULITE 2000, IMMULITE 2500 VANCOMYCIN

K063045 is an FDA 510(k) clearance for IMMULITE 2000, manufactured by Diagnostic Products Corp.. The device is a Class 2 Toxicology device with product code LEH cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K063045 · Diagnostic Products Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
62d
Days
Class 2
Risk

K063045 is an FDA 510(k) clearance for the IMMULITE 2000, IMMULITE 2500 VANCOMYCIN. Classified as Radioimmunoassay, Vancomycin (product code LEH), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on December 5, 2006 after a review of 62 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 Diagnostic Products Corp. devices

FDA 510(k) Submission Details - K063045

510(k) Number K063045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2006
Decision Date December 05, 2006
Days to Decision 62 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
25d faster than avg
Panel avg: 87d · This submission: 62d
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 28
Devices cleared under the same product code (LEH) and FDA review panel - the closest regulatory comparables to K063045.
Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)
K160202 · Siemens Healthcare Diagnostics, Inc. · Apr 2016
ARCHITECT IVANCOMYCIN
K123947 · Biokit, S.A. · Aug 2013
ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01
K072036 · Biokit, S.A. · Mar 2008
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