VANCOMYCIN ASSAY OR THE TECHNICON IMMUNO 1 SYSTEM

K964587 · Bayer Corp. · LEH · Jan 13, 1997 · Clinical Toxicology

Device Facts

• Record ID: K964587
• Device Name: VANCOMYCIN ASSAY OR THE TECHNICON IMMUNO 1 SYSTEM
• Applicant: Bayer Corp.
• Product Code: LEH · Clinical Toxicology
• Decision Date: Jan 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3950
• Device Class: Class 2

Intended Use

This in vitro method is intended to quantitatively measure vancomycin, an antibiotic, in human serum or plasma (heparin) using Syva EMIT® Vancomycin Assay on a Technicon Immuno-1® system. Measurements of vancomycin are used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy.

Device Story

In vitro diagnostic assay for quantitative measurement of vancomycin in human serum or plasma; performed on Technicon Immuno-1® system. Utilizes Syva EMIT® Vancomycin Assay reagents/calibrators. Used by clinical laboratory personnel to monitor antibiotic levels for therapeutic management and overdose diagnosis. Output is a concentration value (μg/mL) used by clinicians to adjust dosing regimens.

Clinical Evidence

Bench testing only. Comparison study performed against Syva EMIT® Vancomycin Assay (n=53). Precision evaluated at multiple concentrations (8.5, 39.5, 50.6 μg/mL) with between-run CVs ranging from 5.3% to 6.6%. Minimum detectable concentration reported as 0.2 μg/mL.

Technological Characteristics

In vitro diagnostic reagent kit for automated chemistry analyzer. Principle: EMIT (Enzyme Multiplied Immunoassay Technique). Form factor: Liquid reagents and calibrators for Technicon Immuno-1® system.

Indications for Use

Indicated for quantitative measurement of vancomycin in human serum or plasma for diagnosis/treatment of vancomycin overdose and therapeutic drug monitoring.

Regulatory Classification

Identification

A vancomycin test system is a device intended to measure vancomycin, an antibiotic drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.

Predicate Devices

• Syva EMIT® Vancomycin Assay (Behring Diagnostics Inc.)

Reference Devices

• Technicon RA-1000® Instrument

Submission Summary (Full Text)

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JAN 08 '97 09:49AM CLIN MED & REG AF
P.2/2
JAN 13 1997
K964587

# SUMMARY OF SAFETY AND EFFECTIVENESS

## Vancomycin Method for Bayer Technicon Immuno 1® System

Listed below is a comparison of the performance between the Immuno 1 Vancomycin method and a similar device that was granted clearance of substantial equivalence (Syva EMIT® Vancomycin Assay, Behring Diagnostics Inc.). The information used in the Summary of Safety and Effectiveness was extracted from the Immuno 1 Vancomycin method sheet and the Syva EMIT® Vancomycin Assay Insert Sheet.

## INTENDED USED

This *in vitro* method is intended to quantitatively measure vancomycin, an antibiotic, in human serum or plasma (heparin) using Syva EMIT® Vancomycin Assay on a *Technicon Immuno-1®* system. Measurements of vancomycin are used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy.

| METHOD | Immuno 1 Vancomycin | | Syva EMIT® Vancomycin
(predicate Device) | |
| --- | --- | --- | --- | --- |
| Part No. | Reagents T01-3705-01 | | Reagents 6W419UL | |
| | Calibrators T03-3714-01 | | Calibrators 6W519UL | |
| Minimum Detectable Conc. | 0.2 μg/mL | | Not Listed | |
| Precision (Between-Run) | 8.5 μg/mL 5.3% | | 7.2 μg/mL 10.3% | |
| | 39.5 μg/mL 6.6% | | 38.7 μg/mL 5.6% | |
| | 50.6 μg/mL 5.3% | | 39.5 μg/mL 6.2% | |
| Correlation | y = 1.032 x - 0.006 | | | |
| | where | | | |
| | y = Immuno 1 Vancomycin method | | | |
| | x = Syva EMIT® Vancomycin Assay+ | | | |
| | n = 53 | | | |
| | r = 0.981 | | | |
| | S_{yx} = 1.779 μg/mL | | | |
| | *This assay was performed on Technicon RA-1000® Instrument using parameters and protocol specified in Behring Application Sheet. | | | |

Gabriel J. Muraca, Jr.
Manager Regulatory Affairs
Bayer Corporation
511 Benedict Avenue
Tarrytown, New York 10591-5097
Date