CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAY

K964765 · Chiron Diagnostics Corp. · KLT · Feb 14, 1997 · Clinical Toxicology

Device Facts

• Record ID: K964765
• Device Name: CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAY
• Applicant: Chiron Diagnostics Corp.
• Product Code: KLT · Clinical Toxicology
• Decision Date: Feb 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3645
• Device Class: Class 2

Indications for Use

For the quantitative determination of carbamazepine in serum or plasma using the Chiron Diagnostics ACS:180® Automated Chemiluminescence Systems.

Device Story

The Chiron Diagnostics ACS:180 Carbamazepine assay is an in vitro diagnostic test used for therapeutic drug monitoring. It utilizes a competitive immunoassay format based on direct chemiluminescence. Patient serum or plasma samples are processed on the ACS:180 Automated Chemiluminescence System. Carbamazepine in the sample competes with an acridinium ester-labeled carbamazepine derivative for binding sites on monoclonal mouse anti-carbamazepine antibodies coupled to paramagnetic particles. The system detects relative light units (RLUs), which are inversely proportional to the carbamazepine concentration in the sample. Results are used by clinicians to establish therapeutic doses, minimize adverse effects, and ensure patient compliance. The assay is intended for use in clinical laboratory settings.

Clinical Evidence

Bench testing only. Method comparison performed on 303 samples (range 0.87–14.06 µg/mL) against an alternate fluorescence polarization method yielded a correlation coefficient (r) of 0.96 and a regression equation of y = 1.01x + 0.71 µg/mL. Total precision (%CV) ranged from 5.4% to 6.7% based on 144 replicates per sample across 4 systems over 3 days. Minimum detectable concentration is 0.2 µg/mL.

Technological Characteristics

Competitive immunoassay using direct chemiluminescence. Reagents include acridinium ester-labeled carbamazepine derivative and monoclonal mouse anti-carbamazepine antibody coupled to paramagnetic particles. System measures relative light units (RLUs). Designed for use on the ACS:180 Automated Chemiluminescence System.

Indications for Use

Indicated for the quantitative measurement of carbamazepine in serum or plasma to assist in therapeutic drug monitoring, dosage adjustment, and assessment of patient compliance in patients undergoing carbamazepine therapy.

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

• TDx® Carbamazepine Assay

Submission Summary (Full Text)

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K964765

# Summary of Safety and Effectiveness

As required by 21 CFR 807.92, the following 510(k) Summary is provided:

## 1. Submitters Information

FEB 14 1997

Contact person: William J. Pignato
Director of Regulatory Affairs

Address: Chiron Diagnostics Corporation
63 North Street
Medfield, MA 02052

Phone: [phone]

Date Summary Prepared: November 22, 1996

## 2. Device Information

Proprietary Name: Chiron Diagnostics ACS:180 Carbamazepine Assay
Common Name: Assay for Carbamazepine

## 3. Predicate Device Information

Name: TDx® Carbamazepine Assay.

Manufacturer: Abbott Laboratories

## 4. Device Description

Therapeutic drug monitoring of carbamazepine helps the physician to establish the therapeutic dose based on individual response to the drug, to adjust dosage to reduce adverse effects while controlling seizures, and to ensure patient compliance with the established regimen.

The Chiron Diagnostics ACS:180 Carbamazepine assay is a competitive immunoassay using direct chemiluminescent technology. Carbamazepine in the patient sample competes with an acridinium ester-labeled carbamazepine derivative in the Lite Reagent for a limited amount of monoclonal mouse anti-carbamazepine antibody, which is coupled to paramagnetic particles in the Solid Phase. An inverse relationship exists between the amount of carbamazepine present in the patient sample and the amount of relative light units (RLUs) detected by the system.

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## 5. Statement of Intended Use

For the quantitative determination of carbamazepine in serum or plasma using the Chiron Diagnostics ACS:180® Automated Chemiluminescence Systems.

## 6. Summary of Technological Characteristics

The Chiron Diagnostics ACS:180 Carbamazepine assay is a competitive immunoassay using direct chemiluminescent technology.

## 7. Performance Characteristics

### Expected Results

A therapeutic range of 4 to 10 µg/mL (16.9 to 42.3 µmol/L) has been previously reported for carbamazepine. As with all therapeutic drug assays, each laboratory should determine the appropriateness of this range for the diagnostic evaluation of patient results.

### Sensitivity

The ACS:180 Carbamazepine assay measures carbamazepine concentrations to 20 µg/mL (84.6 µmol/L) with a minimum detectable concentration of 0.2 µg/mL (0.8 µmol/L). Sensitivity is defined as the concentration of carbamazepine that corresponds to the RLUs that are two standard deviations less than the mean RLUs of 27 replicate determinations of the carbamazepine zero standard.

### Assay Reportable Range

The ACS:180 Carbamazepine assay measures carbamazepine concentrations up to 20 µg/mL (84.6 µmol/L) with a minimum detectable concentration of 0.2 µg/mL (0.8 µmol/L).

### Method Comparison

For 303 samples in the range of 0.87 to 14.06 µg/mL (3.68 to 59.47 µmol/L), the relationship between the ACS:180 Carbamazepine assay and an alternate fluorescence polarization method is described by the equation:

$$
\text{ACS:180 Carbamazepine} = 1.01 \times (\text{alternate method}) + 0.71 \mu\text{g/mL}
$$

$$
\text{Correlation coefficient (r)} = 0.96
$$

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## Precision

Six samples were assayed 6 times in 6 assays, on each of 4 systems (n = 144 for each sample), over a period of 3 days. The following results were obtained:

Total precision (%CV) ranged from 5.4 to 6.70

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