Cleared Traditional

K940595 - AXSYM VANCOMYCIN

K940595 is an FDA 510(k) clearance for AXSYM VANCOMYCIN, manufactured by Abbott Laboratories. The device is a Class 2 Toxicology device with product code LEH cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K940595 · Abbott Laboratories · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
131d
Days
Class 2
Risk

K940595 is an FDA 510(k) clearance for the AXSYM VANCOMYCIN. Classified as Radioimmunoassay, Vancomycin (product code LEH), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on June 21, 1994 after a review of 131 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K940595

510(k) Number K940595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1994
Decision Date June 21, 1994
Days to Decision 131 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
44d slower than avg
Panel avg: 87d · This submission: 131d
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 K940595.
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
OPUS(R) VANCOMYCIN
K924957 · Pb Diagnostic Systems, Inc. · Dec 1992
COBAS-FP REAGENTS FOR VANCOMYCIN
K901759 · Roche Diagnostic Systems, Inc. · May 1990
MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATOR
K900708 · Innotron of Oregon, Inc. · Apr 1990