Cleared Traditional

K964587 - VANCOMYCIN ASSAY OR THE TECHNICON IMMUN...

K964587 is the FDA 510(k) clearance for VANCOMYCIN ASSAY OR THE TECHNICON IMMUN... by Bayer Corp.. It is a Class 2 Toxicology device (product code LEH) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K964587 · Bayer Corp. · Toxicology device
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Jan 1997
Decision
59d
Days
Class 2
Risk

K964587 is an FDA 510(k) clearance for the VANCOMYCIN ASSAY OR THE TECHNICON IMMUNO 1 SYSTEM. Classified as Radioimmunoassay, Vancomycin (product code LEH), Class II - Special Controls.

Submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on January 13, 1997 after a review of 59 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 Bayer Corp. devices

Submission Details

510(k) Number K964587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1996
Decision Date January 13, 1997
Days to Decision 59 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
28d faster than avg
Panel avg: 87d · This submission: 59d
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 22
Devices cleared under the same product code (LEH) and FDA review panel - the closest regulatory comparables to K964587.
EMIT 2000 VANCOMYCIN ASSAY
K020692 · Dade Behring, Inc. · May 2002
SYNCHRON SYSTEMS VANCOMYCIN REAGENT
K013076 · Beckman Coulter, Inc. · Dec 2001
VANCOMYCIN EIA ASSAY
K983280 · Diagnostic Reagents, Inc. · Nov 1998
AXSYM VANCOMYCIN II
K955851 · Abbott Laboratories · May 1996
VANCOMYCIN FPIA REAGENT SET
K955716 · Sigma Diagnostics, Inc. · Feb 1996
ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN
K953528 · Roche Diagnostic Systems, Inc. · Sep 1995