Cleared Traditional

K945125 - DUPONT ACA VANCOMYCIN (VANC) METHOD

K945125 is an FDA 510(k) clearance for DUPONT ACA VANCOMYCIN (VANC) METHOD, manufactured by The DU Pont Co.. The device is a Class 2 Toxicology device with product code LEH cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K945125 · The DU Pont Co. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
142d
Days
Class 2
Risk

K945125 is an FDA 510(k) clearance for the DUPONT ACA VANCOMYCIN (VANC) METHOD. Classified as Radioimmunoassay, Vancomycin (product code LEH), Class II - Special Controls.

Submitted by The DU Pont Co. (Wilimington, US). The FDA issued a Cleared decision on March 10, 1995 after a review of 142 days - within the typical 510(k) review window.

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: 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 The DU Pont Co. devices

FDA 510(k) Submission Details - K945125

510(k) Number K945125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1994
Decision Date March 10, 1995
Days to Decision 142 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
55d slower than avg
Panel avg: 87d · This submission: 142d
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 27
Devices cleared under the same product code (LEH) and FDA review panel - the closest regulatory comparables to K945125.
VANCOMYCIN FPIA REAGENT SET
K955716 · Sigma Diagnostics, Inc. · Feb 1996
ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN
K953528 · Roche Diagnostic Systems, Inc. · Sep 1995
CIBA CORNING ACS VANCOMYCIN IMMUNOASSAY
K951059 · Ciba Corning Diagnostics Corp. · Jun 1995
AXSYM VANCOMYCIN
K940595 · Abbott Laboratories · Jun 1994
OPUS(R) VANCOMYCIN
K924957 · Pb Diagnostic Systems, Inc. · Dec 1992
COBAS-FP REAGENTS FOR VANCOMYCIN
K901759 · Roche Diagnostic Systems, Inc. · May 1990