IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGENTS

K963673 · Beckman Instruments, Inc. · KLT · Feb 4, 1997 · Clinical Toxicology

Device Facts

• Record ID: K963673
• Device Name: IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGENTS
• Applicant: Beckman Instruments, Inc.
• Product Code: KLT · Clinical Toxicology
• Decision Date: Feb 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3645
• Device Class: Class 2

Intended Use

The IMMAGE Immunochemistry System Carbamazepine (CAR) reagent, when used in conjunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 1, is intended for the quantitative determination of carbamazepine in human serum or plasma by rate nephelometric inhibition immunoassay. The IMMAGE Immunochemistry System Phenobarbital (PHE) reagent, when used in conjunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 1, is intended for the quantitative determination of phenobarbital in human serum or plasma by rate nephelometric inhibition immunoassay. The IMMAGE Immunochemistry System Phenytoin (PHY) reagent, when used in conjunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 1, is intended for the quantitative determination of phenytoin in human serum or plasma by rate nephelometric inhibition immunoassay. The IMMAGE Immunochemistry System Theophylline (THE) reagent when, used in conjunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 1, is intended for the quantitative determination of theophylline in human serum or plasma by rate nephelometric inhibition immunoassay. The IMMAGE™ Immunochemistry Systems Drug Calibrator 1, used in conjunction with IMMAGE reagents, is intended for use on Beckman’s IMMAGE Immunochemistry Systems for the calibration of Carbamazepine, Phenobarbital, Phenytoin, and Theophylline test systems.

Device Story

IMMAGE Immunochemistry System reagents perform quantitative analysis of therapeutic drugs (carbamazepine, phenobarbital, phenytoin, theophylline) in human serum or plasma. System utilizes rate nephelometric inhibition immunoassay; reagents react with patient samples; light scattering measured to determine drug concentration. Operated by laboratory personnel on Beckman IMMAGE platform. Output provides drug concentration levels; assists clinicians in therapeutic drug monitoring and dosage adjustment. Benefits include accurate drug level assessment to optimize patient therapy and minimize toxicity.

Clinical Evidence

Bench testing only. Method comparison study (n=103-144 per analyte) against Abbott TDx predicates showed strong correlation (r=0.992-0.996). Within-run imprecision (%CV) ranged from 1.7% to 5.2% across three concentration levels for all analytes. Stability data confirms 24-month shelf-life and 14-day open container/calibration stability.

Technological Characteristics

Liquid stable reagents; rate nephelometric inhibition immunoassay principle; mouse-derived antibodies for CAR, PHE, and PHY; automated analysis on IMMAGE Immunochemistry System.

Indications for Use

Indicated for quantitative determination of carbamazepine, phenobarbital, phenytoin, and theophylline concentrations in human serum or plasma for 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

• TDx® Carbamazepine Reagent (K904226)
• TDx Phenobarbital II Reagent (K904226)
• TDx Phenytoin Reagent (K904226)
• TDx Theophylline II Reagent (K922991)

Submission Summary (Full Text)

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200 South Kraemer Boulevard, Box 8000, Brea, CA 92822-8000 • [phone]

# BECKMAN

## Summary of Safety & Effectiveness

IMMAGE™ Immunochemistry System Therapeutic Drug Monitoring Reagents
[Carbamazepine (CAR), Phenobarbital (PHE), Phenytoin (PHY), and Theophylline (THE)]

K963673

FEB - 4 1997

### 1.0 Submitted By:

Annette Hellie
Regulatory Specialist, Product Submissions
Beckman Instruments, Inc.
200 S. Kraemer Blvd., W-337
Brea, California 92822-8000
Telephone: [phone]
FAX: [phone]

### 2.0 Date Submitted:

12 September 1996

### 3.0 Device Name(s):

#### 3.1 Proprietary Names

IMMAGE™ Immunochemistry System Carbamazepine (CAR) Reagent
IMMAGE™ Immunochemistry System Phenobarbital (PHE) Reagent
IMMAGE™ Immunochemistry System Phenytoin (PHY) Reagent
IMMAGE™ Immunochemistry System Theophylline (THE) Reagent
IMMAGE™ Immunochemistry Systems Drug Calibrator 1

#### 3.2 Classification Names

Carbamazepine Test System (Not Classified)
Phenobarbital Test System (21 CFR §862.3660)
Phenytoin Test System (Not Classified)
Theophylline Test System (21 CFR §862.3880)
Calibrator (21 CFR §862.1150)

### 4.0 Predicate Device(s):

| IMMAGE System Reagent | Predicate | Manufacturer | Docket Number |
| --- | --- | --- | --- |
| Carbamazepine (CAR) Reagent | TDx®** Carbamazepine Reagent | Abbott® Laboratories, Inc. | K904226 |
| Phenobarbital (PHE) Reagent | TDx Phenobarbital II Reagent | Abbott Laboratories, Inc. | K904226 |
| Phenytoin (PHY) Reagent | TDx Phenytoin Reagent | Abbott Laboratories, Inc. | K904226 |
| Theophylline (THE) Reagent | TDx Theophylline II Reagent | Abbott Laboratories, Inc. | K922991 |

*Abbott Laboratories, Abbott Park, IL 60064
**Trademark of Abbott Laboratories

Beckman Instruments, Inc.

twx: 910-592-1260 • telex: 06-78413

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Beckman Instruments, Inc., Section 510(k) Notification
IMMAGE™ Immunochemistry System TDM (CAR, PHE, PHY, & THE) Reagents
Summary of Safety & Effectiveness

## 5.0 Description:

The IMMAGE Immunochemistry System (TDM) CAR, PHE, PHY, and THE Reagents in conjunction with Beckman Drug Calibrator 1, are intended for use in the quantitative determination of carbamazepine, phenobarbital, phenytoin, and theophylline concentrations respectively in human serum and plasma samples on Beckman’s IMMAGE Immunochemistry System.

## 6.0 Intended Use:

The IMMAGE Immunochemistry System Carbamazepine (CAR) reagent, when used in conjunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 1, is intended for the quantitative determination of carbamazepine in human serum or plasma by rate nephelometric inhibition immunoassay.

The IMMAGE Immunochemistry System Phenobarbital (PHE) reagent, when used in conjunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 1, is intended for the quantitative determination of phenobarbital in human serum or plasma by rate nephelometric inhibition immunoassay.

The IMMAGE Immunochemistry System Phenytoin (PHY) reagent, when used in conjunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 1, is intended for the quantitative determination of phenytoin in human serum or plasma by rate nephelometric inhibition immunoassay.

The IMMAGE Immunochemistry System Theophylline (THE) reagent when, used in conjunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 1, is intended for the quantitative determination of theophylline in human serum or plasma by rate nephelometric inhibition immunoassay.

The IMMAGE™ Immunochemistry Systems Drug Calibrator 1, used in conjunction with IMMAGE reagents, is intended for use on Beckman’s IMMAGE Immunochemistry Systems for the calibration of Carbamazepine, Phenobarbital, Phenytoin, and Theophylline test systems.

file: dc1510k.sse

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Beckman Instruments, Inc., Section 510(k) Notification
IMMAGE™ Immunochemistry System TDM (CAR, PHE, PHY, & THE) Reagents
Summary of Safety & Effectiveness

# 7.0 Comparison to Predicate(s):

The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.

| Reagent | Aspect/Characteristic | Comments |
| --- | --- | --- |
| SIMILARITIES | | |
| IMMAGE System (CAR, PHE, PHY, THE) Reagents | Intended use. | Same as Abbott TDx Reagents |
| | Liquid stable reagents. | |
| | Initial analytic ranges. | |
| DIFFERENCES | | |
| IMMAGE System (CAR, PHE, PHY, THE) Reagents | IMMAGE utilizes nephelometric inhibition immunoassay | Abbott TDx reagents utilize fluorescence polarization immunoassay |
| IMMAGE System (CAR, PHE, PHY) Reagents | Antibody source for IMMAGE CAR, PHE, and PHY reagents is mouse. | Antisera source for TDx Carbamazepine, Phenytoin, and Phenobarbital is sheep. |

file: dc1510k.sse

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Beckman Instruments, Inc., Section 510(k) Notification
IMMAGE™ Immunochemistry System TDM (CAR, PHE, PHY, & THE) Reagents
Summary of Safety & Effectiveness

## 8.0 Summary of Performance Data:

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, and imprecision experiments that relate results obtained from the Abbott TDx Reagents to the IMMAGE System Reagents.

### Method Comparison* Study Results
IMMAGE System CAR, PHE, PHY, and THE Reagents

| Analyte | Slope | Intercept | r | n | Predicate Method |
| --- | --- | --- | --- | --- | --- |
| Carbamazepine | 0.982 | 0.17 | 0.992 | 111 | Abbott TDx
Carbamazepine |
| Phenobarbital | 0.998 | -1.18 | 0.996 | 103 | Abbott TDx
Phenobarbital II |
| Phenytoin | 1.051 | -0.76 | 0.996 | 107 | Abbott TDx
Phenytoin |
| Theophylline | 0.992 | 0.12 | 0.995 | 144 | Abbott TDx
Theophylline II |

* Deming Regression statistics used

### Stability Study Results

| Reagent | Product Claim |
| --- | --- |
| IMMAGE CAR, PHE, PHY, and THE | 24 month shelf-life
14 day open container stability
14 day calibration stability |

file: dc1510k.sse

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Beckman Instruments, Inc., Section 510(k) Notification
IMMAGE™ Immunochemistry System TDM (CAR, PHE, PHY, & THE) Reagents
Summary of Safety & Effectiveness
5

## Estimated Within-Run Imprecision

| Sample | Mean (μg/mL) | S.D. (μg/mL) | %C.V. | N |
| --- | --- | --- | --- | --- |
| Carbamazepine (CAR) | | | | |
| Level 1 | 4.76 | 0.214 | 4.5 | 80 |
| Level 2 | 6.94 | 0.288 | 4.2 | 80 |
| Level 3 | 14.6 | 0.37 | 2.6 | 80 |
| Sample | Mean (μg/mL) | S.D. (μg/mL) | %C.V. | N |
| --- | --- | --- | --- | --- |
| Phenobarbital (PHE) Reagent | | | | |
| Level 1 | 9.23 | 0.479 | 5.2 | 80 |
| Level 2 | 35.2 | 1.14 | 3.2 | 80 |
| Level 3 | 62.0 | 1.50 | 2.4 | 80 |
| Sample | Mean (μg/mL) | S.D. (μg/mL) | %C.V. | N |
| --- | --- | --- | --- | --- |
| Phenytoin (PHY) Reagent | | | | |
| Level 1 | 8.23 | 0.201 | 2.4 | 80 |
| Level 2 | 17.3 | 0.35 | 2.0 | 80 |
| Level 3 | 35.9 | 0.59 | 1.7 | 80 |
| Sample | Mean (μg/mL) | S.D. (μg/mL) | %C.V. | N |
| --- | --- | --- | --- | --- |
| Theophylline (THE) Reagent | | | | |
| Level 1 | 8.40 | 0.296 | 3.5 | 80 |
| Level 2 | 20.5 | 0.48 | 2.3 | 80 |
| Level 3 | 33.7 | 0.71 | 2.1 | 80 |

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

file: dc1510k.sse