Cleared Traditional

K955851 - AXSYM VANCOMYCIN II

K955851 is an FDA 510(k) clearance for AXSYM VANCOMYCIN II, 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 134-day FDA review.

K955851 · Abbott Laboratories · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
134d
Days
Class 2
Risk

K955851 is an FDA 510(k) clearance for the AXSYM VANCOMYCIN II. 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 May 9, 1996 after a review of 134 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 - K955851

510(k) Number K955851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1995
Decision Date May 09, 1996
Days to Decision 134 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
47d slower than avg
Panel avg: 87d · This submission: 134d
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 K955851.
VANCOMYCIN EIA ASSAY
K983280 · Diagnostic Reagents, Inc. · Nov 1998
VANCOMYCIN ASSAY OR THE TECHNICON IMMUNO 1 SYSTEM
K964587 · Bayer Corp. · Jan 1997
VANCOMYCIN FLEX REAGENT CARTRIDGE
K963267 · Dade Intl., Inc. · Sep 1996
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