CARBAMAZEPINE FLEX REAGENT CARTRIDGE

K962820 · Dade Intl., Inc. · KLT · Sep 13, 1996 · Clinical Toxicology

Device Facts

• Record ID: K962820
• Device Name: CARBAMAZEPINE FLEX REAGENT CARTRIDGE
• Applicant: Dade Intl., Inc.
• Product Code: KLT · Clinical Toxicology
• Decision Date: Sep 13, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3645
• Device Class: Class 2

Intended Use

The CRBM FLEX™ reagent cartridge used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended to measure carbamazepine, an anti-convulsant drug, in plasma or serum. Measurements obtained by this device are used in the diagnosis and treatment of carbamazepine overdose and in monitoring levels of carbamazepine to ensure appropriate therapy.

Device Story

In vitro diagnostic reagent cartridge for Dimension® clinical chemistry system; measures carbamazepine in human serum/plasma. Uses Particle Enhanced Turbidimetric Inhibition Immunoassay (PETINIA) technique; latex particle-carbamazepine conjugate reacts with carbamazepine-specific monoclonal antibody. Operated by laboratory personnel on automated analyzer. Output provides quantitative carbamazepine concentration; assists clinicians in therapeutic drug monitoring and overdose management.

Clinical Evidence

Method comparison study using 82 samples tested on Dimension® system vs. aca® discrete clinical analyzer. Results: slope 0.99, intercept 0.06, correlation coefficient 0.979, range 0-18.6 µg/mL.

Technological Characteristics

Particle Enhanced Turbidimetric Inhibition Immunoassay (PETINIA); utilizes latex particle-carbamazepine conjugate and monoclonal antibody; prepackaged reagent cartridge format for automated clinical chemistry analyzer.

Indications for Use

Indicated for patients requiring measurement of carbamazepine levels in plasma or serum for diagnosis/treatment of overdose or 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

• aca® carbamazepine analytical test pack

Submission Summary (Full Text)

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DADE
SEP 13 1996
K942820 DADE INTERNATIONAL
Chemistry Systems
P.O. Box 6101
Newark, DE 19714

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

## Carbamazepine FLEX™ Reagent Cartridge

## Summary of Safety and Effectiveness

The CRBM FLEX™ reagent cartridge used on the Dimension® clinical chemistry system is an *in vitro* diagnostic test intended to measure carbamazepine, an anti-convulsant drug, in plasma or serum. Measurements obtained by this device are used in the diagnosis and treatment of carbamazepine overdose and in monitoring levels of carbamazepine to ensure appropriate therapy.

The CRBM method is based on Particle Enhanced Turbidimetric Inhibition Immunoassay (PETINIA) technique which uses a latex particle-carbamazepine conjugate and carbamazepine-specific monoclonal antibody.

The CRBM FLEX™ reagent cartridge is substantially equivalent to the aca® carbamazepine analytical test pack, which was cleared by the FDA via the 510(k) process. Both tests use prepackaged reagents for the determination of carbamazepine in human serum and plasma.

Eighty-two samples were tested with the CRBM FLEX™ reagent cartridge on the Dimension® system and the aca® CRBAM test pack on the aca® discrete clinical analyzer, with the following results:

- slope = 0.99
- intercept = 0.06
- correlation coefficient = 0.979
- range of samples = 0-18.6 µg/mL

Carolyn K. George
Regulatory Affairs and
Compliance Manager

September 4, 1996
Date

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