Cleared Traditional

K955716 - VANCOMYCIN FPIA REAGENT SET

K955716 is the FDA 510(k) clearance for VANCOMYCIN FPIA REAGENT SET by Sigma Diagnostics, Inc.. It is a Class 2 Toxicology device (product code LEH) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K955716 · Sigma Diagnostics, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
63d
Days
Class 2
Risk

K955716 is an FDA 510(k) clearance for the VANCOMYCIN FPIA REAGENT SET. Classified as Radioimmunoassay, Vancomycin (product code LEH), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on February 16, 1996 after a review of 63 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 Sigma Diagnostics, Inc. devices

Submission Details

510(k) Number K955716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1995
Decision Date February 16, 1996
Days to Decision 63 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
24d faster than avg
Panel avg: 87d · This submission: 63d
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 K955716.
VANCOMYCIN EIA ASSAY
K983280 · Diagnostic Reagents, Inc. · Nov 1998
VANCOMYCIN ASSAY OR THE TECHNICON IMMUNO 1 SYSTEM
K964587 · Bayer Corp. · Jan 1997
AXSYM VANCOMYCIN II
K955851 · Abbott Laboratories · May 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