IMMAGE SYSTEM DIGOXIN (DIG) REAGENT/BECKMAN DRUG CALIBRATOR 2

K963062 · Beckman Instruments, Inc. · KXT · Dec 13, 1996 · Clinical Toxicology

Device Facts

• Record ID: K963062
• Device Name: IMMAGE SYSTEM DIGOXIN (DIG) REAGENT/BECKMAN DRUG CALIBRATOR 2
• Applicant: Beckman Instruments, Inc.
• Product Code: KXT · Clinical Toxicology
• Decision Date: Dec 13, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3320
• Device Class: Class 2

Intended Use

The IMMAGE Immunochemistry System Digoxin (DIG) Reagent, in conjunction with Beckman Drug Calibrator 2, is intended for use in the quantitative determination of digoxin in human serum and plasma samples by turbidimetric immunoassay. This assay is designed for use with the IMMAGE Immunochemistry System.

Device Story

IMMAGE Immunochemistry System Digoxin (DIG) Reagent performs quantitative determination of digoxin in human serum and plasma. Device utilizes turbidimetric inhibition immunoassay technology; operates at 37°C. System requires no sample pretreatment. Used in clinical laboratory settings by trained personnel. Output is a quantitative concentration value (ng/mL) used by clinicians to monitor digoxin levels. Benefits include automated, efficient measurement compared to predicate fluorescence polarization methods.

Clinical Evidence

Bench testing only. Performance demonstrated via method comparison against Abbott TDx Digoxin II Reagent using Deming regression (slope 1.011 ± 0.037, intercept 0.047 ± 0.0016, r=0.978). Within-run imprecision evaluated across three levels (0.87, 2.63, 4.19 ng/mL) with CVs ranging from 2.3% to 5.1%. Stability studies confirm 18-month shelf-life and 14-day on-board stability for reagent.

Technological Characteristics

Turbidimetric inhibition immunoassay; operates at 37°C. Analytical range 0.2 to 5 ng/mL. Designed for use on the IMMAGE Immunochemistry System. Reagent shelf-life 18 months; 14-day on-board stability.

Indications for Use

Indicated for the quantitative determination of digoxin concentrations in human serum and plasma samples to assist in clinical monitoring of digoxin levels.

Regulatory Classification

Identification

A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.

Predicate Devices

• Behring Diagnostics N Latex RF (K942328)
• Abbott TDx Digoxin II Reagent (K882233)

Submission Summary (Full Text)

{0}

FROM : BECKMAN INSTRUMENTS
714 961 4457
1996, 12-04
16:01
#757 P.02/05
200 South Kraemer Boulevard, Box 8000, Brea, CA 92822-8000 • [phone]

# BECKMAN

Summary of Safety & Effectiveness
IMMAGE™ Immunochemistry System Digoxin (DIG) Reagent

## 1.0 Submitted By:

K963062

Sheri Hall
Manager, Premarket Regulatory
Margie George
Project Manager, Systems Development
Beckman Instruments, Inc.
200 S. Kraemer Blvd., W-337
Brea, California 92822-8000
Telephone: [phone]
FAX: [phone]

DEC 13 1996

## 2.0 Data Submitted:

04 December 1996

## 3.0 Device Name(s):

### 3.1 Proprietary Names

IMMAGE™ Immunochemistry System Digoxin Reagent
Beckman Drug Calibrator 2

### 3.2 Classification Names

Digoxin immunological test system (21 CFR 866.5775)
Clinical toxicology calibrator (21 CFR 862.3200)

## 4.0 Predicate Device(s):

Behring Diagnostics N Latex RF, K942328
Abbott TDx Digoxin II Reagent, K882233

## 5.0 Description:

The IMMAGE System Digoxin (DIG) Reagent is designed for optimal performance on the IMMAGE Immunochemistry System. It is intended for use in the quantitative determination of digoxin concentrations in human serum and plasma samples.

## 6.0 Intended Use:

The IMMAGE Immunochemistry System Digoxin (DIG) Reagent, in conjunction with Beckman Drug Calibrator 2, is intended for use in the quantitative determination of digoxin in human serum and plasma samples by turbidimetric immunoassay. This assay is designed for use with the IMMAGE Immunochemistry System.

file: ir510k_2.eaa
Beckman Instruments, Inc., Section 510(k) Notification
IMMAGE™ Immunochemistry System Digoxin (DIG) Reagent
Beckman Instruments, Inc.
bnc 910-502-1360 • telex: 06-78413

{1}

FROM :BECKMAN INSTRUMENTS
714 961 4457
1996,12-04
16:02
#767 P.03/05

## 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 | Reagents/Compounds | Comments |
| --- | --- | --- |
| DIG Reagent | Intended use for the measurement of digoxin at 37°C | Same as TDx Digoxin II Reagent |
| | Reagent measures digoxin in both human plasma and serum samples | Same as TDx Digoxin II Reagent |
| | Analytic Range of 0.2 to 5 ng/mL | Same as TDx Digoxin II Reagent |
| DIFFERENCES | | |
| DIG Reagent | Assay Type | IMMAGE System DIG Reagent uses turbidimetric inhibition immunoassay technology while the predicate uses fluorescence polarization immunoassay technology |
| | Sample Pretreatment | IMMAGE System DIG Reagent does not require sample pretreatment while the predicate requires sample pretreatment |

## 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 Digoxin II Reagent to the IMMAGE DIG Reagent.

### Method Comparison Study Results*
IMMAGE DIG Reagent vs. Abbott Digoxin II Reagent

| Analyte | Sample | Method | Pre-Test | Predicate |
| --- | --- | --- | --- | --- |
| IMMAGE DIG | 1.011 ± 0.037 | 0.047 ± 0.0016 | 0.978 | Abbott TDx Digoxin II |

*Deming regression analysis

### Stability Study Results

| Reagent | Reagent Product Claim |
| --- | --- |
| IMMAGE DIG | 18 months shelf-life
14-day on board |
| Drug Calibrator 2 | 24 months shelf-life
14-day calibration |

file: ir610k_2.ssa
Beckman Instruments, Inc., Section 510(k) Notification
IMMAGE™ Immunochemistry System Digoxin (DIG) Reagent

{2}

FROM : BECKMAN INSTRUMENTS
714 961 4457
1996, 12-04
16:02
#767 P.04/05

# Estimated Within-Run Imprecision

| Material | MEAS (R/mL) | SD (R/mL) | VCV | Number of Results |
| --- | --- | --- | --- | --- |
| Level 1 | 0.87 | 0.042 | 4.8 | 15 |
| Level 1 | 1.32 | 0.088 | 5.1 | 80 |
| Level 2 | 2.63 | 0.079 | 3.0 | 80 |
| Level 3 | 4.19 | 0.095 | 2.3 | 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: ir610k_2.exe
Beckman Instruments, Inc., Section 610(k) Notification
IMMAGE™ Immunochorimetry System Digoxin (DIG) Reagent