SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOR

K982935 · Beckman Coulter, Inc. · KXT · Oct 14, 1998 · Clinical Toxicology

Device Facts

• Record ID: K982935
• Device Name: SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOR
• Applicant: Beckman Coulter, Inc.
• Product Code: KXT · Clinical Toxicology
• Decision Date: Oct 14, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3320
• Device Class: Class 2

Intended Use

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

Device Story

The SYNCHRON Systems Digoxin (DIGN) Reagent is an in vitro diagnostic assay used on Beckman SYNCHRON CX and LX clinical chemistry systems. It utilizes a turbidimetric inhibition immunoassay to measure total digoxin levels in human serum or plasma samples. Unlike predicate methods requiring sample pretreatment, this system performs direct analysis. The reagent uses mouse-derived antibodies to bind digoxin in the sample; the resulting turbidity is measured by the system to quantify the drug concentration. The output is a quantitative digoxin value (ng/mL) provided to clinicians to guide therapeutic drug monitoring, adjust dosages, and prevent toxicity in patients undergoing digoxin therapy. The device is intended for use in clinical laboratory settings by trained laboratory personnel.

Clinical Evidence

Bench testing only. Method comparison studies against the predicate (Abbott TDx Digoxin II) using 113 (CX system) and 112 (LX system) serum samples showed high correlation (r=0.991 and r=0.990, respectively). Within-run imprecision studies across three levels of digoxin concentration (0.74–2.49 ng/mL) demonstrated %C.V. values ranging from 1.78% to 6.96%.

Technological Characteristics

Turbidimetric inhibition immunoassay; liquid stable reagents; mouse-derived antibodies; no sample pretreatment required. Designed for use on automated SYNCHRON CX and LX clinical chemistry systems. Quantitative measurement of digoxin in serum or plasma.

Indications for Use

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

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

• TDx® Digoxin II (K882233)

Submission Summary (Full Text)

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1 1 4 100

K982935

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Summary of Safety & Effectiveness SYNCHRON® Systems Digoxin (DIGN) Reagent

## 1.0 Submitted By:

Lucinda Stockert Staff Regulatory Specialist, Product Submissions Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: [phone] FAX: [phone]

#### 2.0 Date Submitted:

August 19, 1998

#### 3.0 Device Name(s):

# 3.1 Proprietary Names

SYNCHRON® Systems Digoxin (DIGN) Reagent SYNCHRON® Systems Drug Calibrator 2

## Classification Name 3.2

Digoxin (21CFR §862.3320) Calibrator (21 CFR §862.3200)

#### 4.0 Predicate Device(s):

| SYNCHRON Systems<br>Reagent | Predicate | Manufacturer | Docket<br>Number |
|----------------------------------------|-------------------|------------------------------|------------------|
| SYNCHRON®<br>Systems Digoxin<br>(DIGN) | TDx®** Digoxin II | Abbott* Laboratories,<br>Inc | K882233 |

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

#### 5.0 Description:

The SYNCHRON System Digoxin (DIGN) Reagent is designed for optimal performance on the SYNCHRON CX and LX Systems. It is intended for use in the quantitative determination of Digoxin in human serum or plasma.

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## 6.0 Intended Use:

The SYNCHRON® Systems Digoxin (DIG) Reagent, when used in conjunction with Beckman SYNCHRON® Systems and SYNCHRON® Systems Drug Calibrator 2 set, is intended for the quantitative determination of total digoxin in human serum or plasma on SYNCHRON® Systems.

The SYNCHRON® Systems Drug Calibrator 2, used in conjunction with SYNCHRON® Digoxin reagent, is intended for use on Beckman's SYNCHRON Systems for the calibration of Digoxin 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.

| | SIMILARITIES | |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| SYNCHRON®<br>Systems Digoxin<br>(DIGN) | Intended use. | Same as Abbott TDx<br>Digoxin II Reagent |
| | Liquid stable reagents.<br>Multipoint Calibration Scheme<br>Reagent measures digoxin in<br>both human plasma and<br>serum samples | |
| | DIFFERENCES | |
| SYNCHRON®<br>Systems Digoxin<br>(DIGN) | SYNCHRON DIGN utilizes<br>turbidimetric inhibition<br>immunoassay | Abbott TDx Digoxin reagent<br>utilizes fluorescence<br>polarization immunoassay |
| | Antibody source for<br>SYNCHRON DIGN is mouse. | Antisera source for TDx<br>Digoxin II is rabbit. |
| | Sample Pretreatment | SYNCHRON Systems DIGN<br>does not require sample<br>pretreatment while the<br>predicate requires sample<br>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.

| SYNCHRON<br>DIGN Reagent | Sample<br>Type | Slope | Intercept<br>(ng/mL) | r | n | Predicate<br>Method |
|--------------------------|----------------|-------|----------------------|-------|-----|--------------------------|
| SYNCHRON<br>CX System | serum | 1.053 | -0.03 | 0.991 | 113 | Abbott TDx<br>Digoxin II |
| SYNCHRON<br>LX System | serum | 1.054 | -0.06 | 0.990 | 112 | Abbott TDx<br>Digoxin II |

Method Comparison Study Results

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| SYNCHRON<br>System | Sample | Mean<br>(ng/mL) | S.D. (ng/mL) | %C.V. | N |
|--------------------|---------|-----------------|--------------|-------|----|
| | Level 1 | 0.74 | 0.05 | 6.96 | 80 |
| CX | Level 2 | 1.73 | 0.06 | 3.29 | 80 |
| | Level 3 | 2.48 | 0.05 | 1.80 | 80 |
| | Level 1 | 0.80 | 0.05 | 6.06 | 80 |
| LX | Level 2 | 1.78 | 0.03 | 1.78 | 80 |
| | Level 3 | 2.49 | 0.07 | 2.62 | 80 |

## Estimated Within-Run Imprecision

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.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 1 4 1998

Lucinda Stockert . Staff Regulatory Specialist Beckman Coulter, Inc. 200 S. Kraemer Boulevard, M/S W-104 P.O. Box 8000 Brea, California 92822-8000

Re : K982935 SYNCHRON® Systems Digoxin Reagent Requlatory Class: II Product Code: KXT, DLJ Dated: August 19, 1998 Received: August 21, 1998

Dear Ms. Stockert:

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 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 Requlations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set torth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Sitman

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)

510(k) Number (if known):

Device Name: SYNCHRON® Systems Digoxin (DIGN) Reagent

Indications for Use:

The SYNCHRON® Systems Digoxin (DIGN) Reagent, when used in conjunction with Beckman SYNCHRON® Systems and SYNCHRON® Systems Drug Calibrator 2 set, is intended for the quantitative determination of total digoxin in human serum or plasma on SYNCHRON® Systems.

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

Clinical Significance:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off Division of Clinical Laboratory D 510(k) Number. Prescription Use OR Over-the-Counter Use (per 21 CFR 801.109) Optional Format 1-2-96