QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)

K964116 · Bayer Corp. · LBZ · Dec 24, 1996 · Clinical Toxicology

Device Facts

• Record ID: K964116
• Device Name: QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
• Applicant: Bayer Corp.
• Product Code: LBZ · Clinical Toxicology
• Decision Date: Dec 24, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3320
• Device Class: Class 2

Intended Use

This in vitro method is intended to quantitatively measure Quinidine, an anti-arrhythmic drug, in human serum or plasma (heparin) using Syva EMIT® 2000 Assay on a Technicon Immuno-1® system. Measurements of quinidine are used in the diagnosis and treatment of quinidine overdose and in monitoring serum levels of quinidine to ensure appropriate therapy.

Device Story

In vitro diagnostic assay for quantitative measurement of quinidine in human serum or plasma; utilizes Technicon Immuno-1® system; intended for clinical laboratory use by trained personnel; provides serum concentration data to clinicians for therapeutic drug monitoring and overdose assessment; aids in optimizing anti-arrhythmic drug therapy.

Clinical Evidence

Bench testing only. Comparison of Immuno 1 Quinidine method against Syva EMIT® 2000 predicate. Precision evaluated at 1.2, 3.5, and 6.0 μg/mL concentrations with CVs of 5.5%, 4.8%, and 5.3% respectively. Correlation study (n=25) yielded r=0.991, slope 1.02, intercept -0.16. Minimum detectable concentration 0.06 μg/mL.

Technological Characteristics

In vitro diagnostic reagent system for use on Technicon Immuno-1® automated analyzer. Quantitative immunoassay principle. Reagents and calibrators provided for serum/plasma analysis.

Indications for Use

Indicated for patients requiring monitoring of serum quinidine levels for therapeutic management or diagnosis of quinidine overdose.

Regulatory Classification

Identification

A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.

Predicate Devices

• Syva EMIT® 2000 Quinidine Assay (Behring Diagnostics Inc.)

Reference Devices

• Roche COBAS FARA II® Instrument

Submission Summary (Full Text)

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K964116
DEC 24 1996

# SUMMARY OF SAFETY AND EFFECTIVENESS

## Quinidine Method for Bayer Technicon Immuno 1® System

Listed below is a comparison of the performance between the Immuno 1 Quinidine method and a similar device that was granted clearance of substantial equivalence (Syva EMIT® 2000 Quinidine Assay, Behring Diagnostics Inc.). The information used in the Summary of Safety and Effectiveness was extracted from the Immuno 1 Quinidine method sheet and the Syva EMIT® 2000 Quinidine Assay insert.

## INTENDED USED

This *in vitro* method is intended to quantitatively measure Quinidine, an anti-arrhythmic drug, in human serum or plasma (heparin) using Syva EMIT® 2000 Assay on a *Technicon Immuno-1®* system. Measurements of quinidine are used in the diagnosis and treatment of quinidine overdose and in monitoring serum levels of quinidine to ensure appropriate therapy.

| METHOD | Immuno 1 Quinidine | | Syva EMIT® 2000
(predicate Device) | |
| --- | --- | --- | --- | --- |
| Part No. | Reagents T01-3678-51 | | Reagents | 4Q019UL |
| | Calibrators T03-3680-01 | | Calibrators | 4Q109UL |
| Minimum Detectable Conc. | 0.06 μg/mL | | 0.25 μg/mL | |
| Precision (Between-Run) | 1.2 μg/mL | 5.5% | 1.5 μg/mL | 6.5% |
| | 3.5 μg/mL | 4.8% | 3.4 μg/mL | 5.2% |
| | 6.0 μg/mL | 5.3% | 5.7 μg/mL | 5.6% |
| Correlation | y = 1.02x - 0.16 | | | |
| | where
y = Immuno 1 Quinidine method | | | |
| | x = Syva EMIT® 2000 Quinidine Assay* | | | |
| | n = 25 | | | |
| | r = 0.991 | | | |
| | S_{yx} = 0.148 μg/mL | | | |
| *This assay was performed on Roche COBAS FARA II® Instrument. | | | | |

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

*Please Note: Additional # patients requested, DATA provided in 11/26/96 memo. No significant change in correlation. R013.

10/10/96
Date

12/9/96