CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM

K964068 · Bayer Corp. · KLT · Dec 13, 1996 · Clinical Toxicology

Device Facts

• Record ID: K964068
• Device Name: CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
• Applicant: Bayer Corp.
• Product Code: KLT · Clinical Toxicology
• Decision Date: Dec 13, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3645
• Device Class: Class 2

Intended Use

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

Device Story

In vitro diagnostic assay for quantitative measurement of carbamazepine in human serum or plasma; performed on Technicon Immuno-1® system. Uses chemical reagents and calibrators to detect drug concentration; provides numerical output in μg/mL. Used in clinical laboratory settings by trained personnel. Results assist clinicians in monitoring therapeutic drug levels and managing carbamazepine overdose, ensuring appropriate patient therapy.

Clinical Evidence

Bench testing only. Performance compared against predicate using 50 clinical samples. Correlation: y = 1.07x - 0.13, r = 0.978, S_yx = 0.89 μg/mL. Precision (between-run) evaluated at multiple concentrations (2.8–16.1 μg/mL) showing CVs ranging from 4.2% to 8.7%.

Technological Characteristics

In vitro diagnostic reagent kit for automated immunoassay. Principle: quantitative measurement of carbamazepine. System: Technicon Immuno-1®. Minimum detectable concentration: 0.2 μg/mL.

Indications for Use

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

Regulatory Classification

Identification

A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.

Predicate Devices

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

Reference Devices

• Roche COBAS FARA II® Instrument

Submission Summary (Full Text)

{0}

K964068
Dec. 13, 1996

# SUMMARY OF SAFETY AND EFFECTIVENESS

## Carbamazepine Method for Bayer Technicon Immuno 1® System

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

## INTENDED USED

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

| METHOD | Immuno 1 Carbamazepine | | Syva EMIT® 2000
(predicate Device) | |
| --- | --- | --- | --- | --- |
| Part No. | Reagents T01-3677-51 | | Reagents 4F019UL | |
| | Calibrators T03-3679-01 | | Calibrators 4F109UL | |
| Minimum Detectable Conc. | 0.2 μg/mL | | 0.5 μg/mL | |
| Precision (Between-Run) | 2.8 μg/mL | 3.9% | 4.0 μg/mL | 7.3% |
| | 9.6 μg/mL | 4.2% | 10.0 μg/mL | 5.9% |
| | 16.1 μg/mL | 8.7% | 16.3 μg/mL | 5.6% |
| Correlation | y = 1.07x - 0.13 | | | |
| | where | | | |
| | y = Immuno 1 Carbamazepine method | | | |
| | x = Syva EMIT® 2000 Carbamazepine Assay* | | | |
| | n = 50 | | | |
| | r = 0.978 | | | |
| | S_{yx} = 0.89 μg/mL | | | |
| *This assay was performed on Roche COBAS FARA II® Instrument. | | | | |

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

10/21/96