IMMAGE IMMUNOCHEMISTRY SYSTEM GENTAMICIN(GEN)/TOBRAMYCIN(TOB) REAGENT / BECKMAN DRUG CLAIBRATOR 3 PLUS

K964009 · Beckman Instruments, Inc. · DNO · Feb 11, 1997 · Clinical Toxicology

Device Facts

• Record ID: K964009
• Device Name: IMMAGE IMMUNOCHEMISTRY SYSTEM GENTAMICIN(GEN)/TOBRAMYCIN(TOB) REAGENT / BECKMAN DRUG CLAIBRATOR 3 PLUS
• Applicant: Beckman Instruments, Inc.
• Product Code: DNO · Clinical Toxicology
• Decision Date: Feb 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3450
• Device Class: Class 2

Intended Use

The IMMAGE Immunochemistry System Gentamicin (GEN) reagent, when used in conjunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 3 Plus, is intended for the quantitative determination of cgentamicin in human serum or plasma by rate nephelometric inhibition immunoassay. The IMMAGE Immunochemistry System Tobramycin (TOB) reagent, when used in conjunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 3 Plus, is intended for the quantitative determination of tobramycin in human serum or plasma by rate nephelometric inhibition immunoassay. Beckman Drug Calibrator 3 Plus, used in conjunction with IMMAGE reagents, is intended for use on Beckman's IMMAGE™ Immunochemistry Systems for the calibration of Gentamicin and Tobramycin test systems.

Device Story

The IMMAGE Immunochemistry System uses liquid-stable reagents and Beckman Drug Calibrator 3 Plus to measure gentamicin and tobramycin concentrations in human serum or plasma. The system employs a rate nephelometric inhibition immunoassay principle. Samples are processed on the IMMAGE Immunochemistry System, which detects light scattering changes to quantify drug levels. The device is intended for clinical laboratory use. Results assist healthcare providers in therapeutic drug monitoring to optimize dosing and minimize toxicity. The system provides quantitative outputs used for clinical decision-making regarding patient drug therapy.

Clinical Evidence

Bench testing only. Method comparison studies against Abbott TDx predicates showed high correlation for Gentamicin (n=135, r=0.998, slope=0.994) and Tobramycin (n=94, r=0.996, slope=1.009). Within-run imprecision studies (n=80 per level) demonstrated %C.V. values ranging from 1.7% to 6.2% across therapeutic ranges. Stability testing confirmed 24-month shelf-life and 14-day open-container/calibration stability.

Technological Characteristics

Liquid-stable reagents; rate nephelometric inhibition immunoassay principle; mouse-derived antibodies; automated system-based analysis; intended for use with Beckman IMMAGE Immunochemistry System.

Indications for Use

Indicated for the quantitative determination of gentamicin and tobramycin concentrations in human serum or plasma for therapeutic drug monitoring.

Regulatory Classification

Identification

A gentamicin test system is a device intended to measure gentamicin, an antibiotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.

Predicate Devices

• TDx® Gentamicin Reagent (K904226)
• TDx Tobramycin Reagent (K904226)

Submission Summary (Full Text)

{0}

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

# BECKMAN

## Summary of Safety & Effectiveness

### IMMAGE™ Immunochemistry System Therapeutic Drug Monitoring Reagents

#### [Gentamicin (GEN) and Tobramycin (TOB)]

FEB 11 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:

03 October 1996

### 3.0 Device Name(s):

#### 3.1 Proprietary Names

IMMAGE™ Immunochemistry System Gentamicin (GEN) Reagent
IMMAGE™ Immunochemistry System Tobramycin (TOB) Reagent
Beckman Drug Calibrator 3 Plus

#### 3.2 Classification Names

Gentamicin Test System (21 CFR §862.3450)
Tobramycin Test System (21 CFR §862.3900)
Calibrator (21 CFR §862.1150)

### 4.0 Predicate Device(s):

| IMMAGE System Reagent | Predicate | Manufacturer | Docket Number |
| --- | --- | --- | --- |
| Gentamicin (GEN) Reagent | TDx®** Gentamicin Reagent | Abbott® Laboratories, Inc. | K904226 |
| Tobramycin (TOB) Reagent | TDx Tobramycin Reagent | Abbott Laboratories, Inc. | K904226 |

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

Beckman Instruments, Inc.

twx: 910-592-1260 • telex: 06-78413

{1}

Beckman Instruments, Inc., Section 510(k) Notification
IMMAGE™ Immunochemistry System TDM (GEN & TOB) Reagents
Summary of Safety & Effectiveness

## 5.0 Description:

The IMMAGE Immunochemistry System (TDM) GEN and TOB Reagents in conjunction with Beckman Drug Calibrator 3 Plus, are intended for use in the quantitative determination of gentamicin and tobramycin concentrations respectively in human serum and plasma samples on Beckman's IMMAGE Immunochemistry System.

## 6.0 Intended Use:

The IMMAGE Immunochemistry System Gentamicin (GEN) reagent, when used in conjunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 3 Plus, is intended for the quantitative determination of cgentamicin in human serum or plasma by rate nephelometric inhibition immunoassay.

The IMMAGE Immunochemistry System Tobramycin (TOB) reagent, when used in conjunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 3 Plus, is intended for the quantitative determination of tobramycin in human serum or plasma by rate nephelometric inhibition immunoassay.

Beckman Drug Calibrator 3 Plus, used in conjunction with IMMAGE reagents, is intended for use on Beckman's IMMAGE™ Immunochemistry Systems for the calibration of Gentamicin and Tobramycin test systems.

## 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 |
| --- | --- | --- |
| GEN | | |
| IMMAGE System (GEN & TOB) Reagents | Intended use. | Same as Abbott TDx Reagents |
| | Liquid stable reagents. | |
| TOB | | |
| IMMAGE System (GEN & TOB) Reagents | IMMAGE utilizes nephelometric inhibition immunoassay | Abbott TDx reagents utilize fluorescence polarization immunoassay |
| IMMAGE System (GEN & TOB) Reagents | Antibody source for IMMAGE GEN & TOB reagents is mouse. | Antisera source for TDx Gentamicin and Tobramycin is sheep. |

file: dc3510k.sae

{2}

Beckman Instruments, Inc., Section 510(k) Notification
IMMAGE™ Immunochemistry System TDM (GEN & TOB) 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 GEN, TOB, PHY, and THE Reagents

| Analyte | Slope | Intercept | r | n | Predicate Method |
| --- | --- | --- | --- | --- | --- |
| Gentamicin | 0.994 | -0.05 | 0.998 | 135 | Abbott TDx
Gentamicin |
| Tobramycin | 1.009 | -0.12 | 0.996 | 94 | Abbott TDx
Tobramycin |

* Deming Regression statistics used

### Stability Study Results

| Reagent | Product Claim |
| --- | --- |
| IMMAGE GEN & TOB | 24 month shelf-life
14 day open container stability
14 day calibration stability |

### Estimated Within-Run Imprecision

| Sample | Mean (μg/mL) | S.D. (μg/mL) | %C.V. | N |
| --- | --- | --- | --- | --- |
| Gentamicin (GEN) | | | | |
| Level 1 | 1.52 | 0.095 | 6.2 | 80 |
| Level 2 | 5.96 | 0.107 | 1.8 | 80 |
| Level 3 | 11.0 | 0.26 | 2.4 | 80 |
| Sample | Mean (μg/mL) | S.D. (μg/mL) | %C.V. | N |
| --- | --- | --- | --- | --- |
| Tobramycin (TOB) Reagent | | | | |
| Level 1 | 1.5 | 0.073 | 4.9 | 80 |
| Level 2 | 5.93 | 0.098 | 1.7 | 80 |
| Level 3 | 10.9 | 0.23 | 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: dc3510k.sse