IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT

K983151 · Beckman Coulter, Inc. · KXT · Nov 5, 1998 · Clinical Toxicology

Device Facts

• Record ID: K983151
• Device Name: IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT
• Applicant: Beckman Coulter, Inc.
• Product Code: KXT · Clinical Toxicology
• Decision Date: Nov 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3320
• Device Class: Class 2

Intended Use

The IMMAGE® Immunochemistry System Digoxin (DIG) Reagent, when used in conjunction with Beckman Coulter's IMMAGE® Immunochemistry Systems and IMMAGE® Immunochemistry Systems Drug Calibrator 2, is intended for the quantitative determination of digoxin in human serum or plasma by turbidimetric immunoassay. The IMMAGE® Immunochemistry Systems Drug Calibrator 2, used in conjunction with IMMAGE® Digoxin reagent, is intended for use on Beckman Coulter's IMMAGE® Immunochemistry Systems for the calibration of digoxin test systems.

Device Story

The IMMAGE® Immunochemistry System Digoxin (DIG) Reagent is an in vitro diagnostic reagent used on the IMMAGE® Immunochemistry System. It accepts human serum or plasma samples. The device utilizes Near Infrared Particle Immunoassay (NIPIA) rate methodology; a turbidimetric immunoassay where mouse monoclonal antibodies react with digoxin in the sample. The system performs automated analysis to provide a quantitative result. It is intended for use in clinical laboratory settings by trained personnel. The output is a digoxin concentration value, which healthcare providers use to monitor therapeutic levels, adjust dosages, and prevent toxicity in patients undergoing digoxin therapy for heart failure or cardiac arrhythmias.

Clinical Evidence

Bench testing only. Method comparison study against Abbott TDx Digoxin II using 113 serum samples yielded a slope of 1.051, intercept of 0.13 ng/mL, and correlation coefficient (r) of 0.993. Imprecision studies (n=80 per level) showed within-run %C.V. ranging from 2.6% to 7.2% and total imprecision %C.V. ranging from 2.8% to 7.4% across three concentration levels (1.04, 2.28, and 3.76 ng/mL).

Technological Characteristics

Near Infrared Particle Immunoassay (NIPIA) rate methodology; turbidimetric immunoassay. Uses mouse monoclonal antibodies. Operates at 37°C. Requires 12 µL sample volume. Designed for use on the IMMAGE® Immunochemistry System. No sample pretreatment required.

Indications for Use

Indicated for the quantitative determination of digoxin in human serum or plasma to monitor digoxin therapy for heart failure or cardiac arrhythmias, specifically to assess for potential toxicity or inadequate therapeutic response.

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

• Abbott TDx Digoxin II Reagent

Submission Summary (Full Text)

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5 1998 NOV

Summary of Safety & Effectiveness Beckman Coulter IMMAGE® Immunochemistry System Digoxin (DIG) Reagent

## 1.0 Submitted By:

Richard T. Ross Staff Requlatory Specialist. Product Submissions Beckman Coulter, Inc. 200 South Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: [phone] FAX: [phone]

# 2.0 Date Submitted:

09 September 1998

# 3.0 Device Name(s):

## 3.1 Proprietary Names

IMMAGE® Immunochemistry System Digoxin (DIG) Reagent

## 3.2 Classification Name

Digoxin Test System (21 CFR §862.3320)

## 4.0 Predicate Device(s):

| NAME OF HONDANIE EN END STATE OF STATE FOR FOR FOR FOR FOR FOR FOR FOR FOR AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND<br> | 16 INCREASE A MARCHITE WORKER BOOK ON LIE LIE WAS | <br>BAND DOG RECORD FOR COLLECTION CONSTITUTION OF | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASSURES OF PARK IS E SER OIL OF C E SE E SAN ASSOCIATED STATUS CHOOL S WALLERS | | Abbott™ Laboratones, Inc | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| ------------------ | Company of Children Company of Children Company of | SECTION BO MIT 13 THE CONTROLLERS CONTROL CONSULTION CONSULTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |

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

## 5.0 Description:

The IMMAGE® Immunochemistry System Digoxin (DIG) Reagent is designed for optimal performance on the IMMAGE® Immunochemistry Systems. It is intended for the quantitative determination of Digoxin in serum and plasma.

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. ... --Telephone: [phone] Facsimile: [phone] Internet: www.beckmancoulter.com

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#### 6.0 Intended Use:

The IMMAGE® Immunochemistry System Digoxin (DIG) Reagent, when used in conjunction with Beckman Coulter's IMMAGE® Immunochemistry Systems and IMMAGE® Immunochemistry Systems Drug Calibrator 2, is intended for the quantitative determination of digoxin in human serum or plasma by turbidimetric immunoassay.

The IMMAGE® Immunochemistry Systems Drug Calibrator 2, used in conjunction with IMMAGE® Digoxin reagent, is intended for use on Beckman Coulter's IMMAGE® Immunochemistry Systems for the calibration of digoxin test systems.

#### 7.0 Comparison to Predicate(s):

The following tables show similarities and differences between the predicate identified in Section 4.0 of this summary.

| Reagent | Aspect/Characteristic | Comments |
|------------------------------|----------------------------------|-------------------------------------------|
| IMMAGE System<br>DIG Reagent | Intended use. | Same as Abbott TDx<br>Digoxin II Reagent. |
| | Reaction temperature of 37° C. | |
| | Sample types of plasma or serum. | |

# SIMILARITIES to the PREDICATE

# DIFFERENCES from the PREDICATE

| Reagent | Aspect/Characteristic | Comments |
|---------------------------------|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| IMMAGE<br>System DIG<br>Reagent | IMMAGE DIG uses Near Infrared<br>Particle Immunoassay (NIPIA) rate<br>immunoassay methodology. | Abbott TDx reagents utilize<br>fluorescence polarization<br>immunoassay. |
| | Antibody source for IMMAGE DIG is<br>mouse monoclonal. | Antiserum source for TDx<br>Digoxin II is rabbit. |
| | IMMAGE System DIG uses a single<br>point calibration. | TDx System Digoxin II<br>calibration is multipoint. |
| IMMAGE<br>System DIG<br>Sample | IMMAGE System DIG requires a<br>sample volume of 12 µL. | TDx Digoxin II requires a<br>sample volume of 160µL. |
| | IMMAGE DIG does not require<br>sample pretreatment. | TDx Digoxin II requires<br>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 and imprecision experiments.

Beckman Coulter, Inc. 510(k) Notification IMMAGE® Digoxin Reagent Filename: digSSE.doc

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# Method Comparison Study Results IMMAGE® Immunochemistry System Digoxin (DIG) Reagent

| Analyte | Sample Type | Slope | Intercept (ng/mL) | r | n | Predicate Method |
|-----------------------|-------------|-------|-------------------|-------|-----|--------------------------|
| IMMAGE<br>DIG Reagent | serum | 1.051 | 0.13 | 0.993 | 113 | Abbott TDx<br>Digoxin II |

# Estimated IMMAGE System Digoxin (DIG) Reagent Imprecision

| Sample | Mean (ng/mL) | S.D. (ng/mL) | %C.V. | N |
|------------------------|--------------|--------------|-------|----|
| Within-Run Imprecision | | | | |
| Level 1 | 1.04 | 0.075 | 7.2 | 80 |
| Level 2 | 2.28 | 0.060 | 2.6 | 80 |
| Level 3 | 3.76 | 0.101 | 2.7 | 80 |
| Total Imprecision | | | | |
| Level 1 | 1.04 | 0.077 | 7.4 | 80 |
| Level 2 | 2.28 | 0.064 | 2.8 | 80 |
| Level 3 | 3.76 | 0.113 | 3.0 | 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.

Beckman Coulter, Inc. 510(k) Notification IMMAGE® Digoxin Reagent Filename: digSSE.doc

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 5 1998

Richard T. Ross Staff Regulatory Specialist Beckman Coulter, Inc. 200 South Kraemer Blvd., W-104 Brea, CA 92822-8000

Re: K983151

Trade Name: Immage Immunochemistry System Digoxin (DIG) Reagent Regulatory Class: II Product Code: KXT Dated: September 9, 1998 Received: September 9, 1998

Dear Mr. Ross:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Ouality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours.

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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page **_ of _**

510(k) Number (if known): Not yet assigned

IMMAGE® Immunochemistry System Device Name: Digoxin (DIG) Reagent

Indications for Use:

The IMMAGE® Immunochemistry System Digoxin (DIG) Reagent, when used in conjunction with Beckman IMMAGE® Immunochemistry Systems and Beckman Drug Calibrator 2, is intended for the quantitative determination of digoxin in human serum or plasma by turbidimetric immunoassay.

Clinical Significance:

Digoxin is administered for conditions of heart failure or in the treatment of certain cardiac arrhythmias. Digoxin therapy is monitored for possible toxicity and inadequate therapuetic response.

Digoxin (21 CFR §862.3320) (b) Classification. Class II.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) OR Over-the-Counter Use Prescription Use (per 21 CFR 801.109) Optional Format 1-2-96

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K983/151
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