DIGOXIN ASSAY FOR THE TECHNICON RA / OPERA SYSTEMS

K980521 · Bayer Corp. · KXT · Apr 2, 1998 · Clinical Toxicology

Device Facts

• Record ID: K980521
• Device Name: DIGOXIN ASSAY FOR THE TECHNICON RA / OPERA SYSTEMS
• Applicant: Bayer Corp.
• Product Code: KXT · Clinical Toxicology
• Decision Date: Apr 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3320
• Device Class: Class 2

Intended Use

This in vitro diagnostic procedure is intended to quantitatively measure the concentration of digoxin in human serum and plasma on the Technicon RA/opeRA systems. Measurements obtained with this procedure are used to monitor circulating levels of this drug so that proper therapeutic level is maintained while avoiding toxicity.

Device Story

In vitro diagnostic assay for quantitative measurement of digoxin in human serum or plasma; utilizes Syva Emit 2000 reagents on Technicon RA/opeRA chemistry systems. System processes patient samples to determine drug concentration; results used by clinicians to monitor therapeutic levels and prevent toxicity. Operated by laboratory personnel in clinical settings. Output provides numerical concentration values for clinical decision-making regarding patient medication management.

Clinical Evidence

Bench testing only. Performance comparison provided between Technicon RA/opeRA and Bayer Immuno 1 methods. Precision reported at multiple concentrations (0.4, 1.3, 2.8 ng/mL). Correlation study (n=39) yielded r=0.949, y=1.08x+0.11.

Technological Characteristics

In vitro diagnostic chemistry assay; utilizes Syva Emit 2000 reagents. Designed for use on Technicon RA-500, RA-1000, RA-XT, RA-2000, and opeRA automated chemistry systems. Quantitative measurement principle based on immunoassay methodology.

Indications for Use

Indicated for the quantitative measurement of digoxin in human serum or plasma to monitor therapeutic drug levels and avoid toxicity in patients undergoing digoxin therapy.

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

• Bayer Immuno 1 Digoxin method

Submission Summary (Full Text)

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## SUMMARY OF SAFETY AND EFFECTIVENESS

## Technicon RAM and opeRA Chemistry Systems Digoxin (Procedure Using Syva Emit 2000* Reagents)

Listed below is a companson of the performance between the Technicon RA/opeRA Digoxin method and a similar device that was granted clearance of substantial equivalence (Bayer Immuno 1 Digoxin method). The information used in the Summary of Safety and Effectiveness was extracted from the RA/opeRA Digoxin method sheet and the Immuno 1 Digoxin method sheet.

## INTENDED USE

This in vitro diagnostic procedure is intended to quantitatively measure the concentration of digoxin in human senum and plasma on the Technicon RA/opeRA systems. Measurements obtained with this procedure are used to monitor circulating levels of this drug so that proper therapeutic level is maintained while avoiding toxicity.

| METHOD | | RA/opeRA | Immuno 1 |
|--------------------|-------------------------|---------------------------------------------------------------------------------------|-------------------------------------------------------|
| Part No. | Reagents<br>Calibrators | T-4H019<br>T-4H209 | T01-2875-51<br>T03-2864-01 |
| Minimum Det. Conc. | | 0.20 ng/mL | 0.04 ng/mL |
| Precision (Total) | | 20.0% @ 0.4ng/mL<br>9.0% @ 1.3ng/mL<br>9.0% @ 2.8ng/mL | 8.2% @ 0.7ng/mL<br>4.2% @ 2.2ng/mL<br>3.6% @ 3.4ng/mL |
| Correlation | | y=1.08x+0.11<br>where<br>y=RA/opeRA<br>x=Immuno 1<br>n=39<br>r=0.949<br>Syx=0.2 ng/mL | Range of RA analyte concentration = 0,2 - 2.8 ng/mL |

Gabriel J. Munoz, Jr.

Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation, BG-DS 511 Benedict Ave. Tarrytown, NY. 10591-5097 Tele. 914-524-3494

3/20/98

**Date**

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR - 2 1998

Gabriel Muraca, Jr. . Manager of Regulatory Affairs Baver Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097

Re : K980521 Syva Emit® 2000 Digoxin Assay and Calibrator for the Technicon RA®/opeRA™ Systems Requlatory Class: II Product Code: KXT Dated: March 10, 1998 Received: March 12, 1998

Dear Mr. Muraca:

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 The general controls provisions of the Act of the Act. include reguirements 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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth 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 In addition, FDA may publish further announcements action. 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 Litman

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 1 of 1

510(k) Number (if known): K982521

Device Name: Technicaon RA® and opeRA Chemistry Systems
Uring Suya Transis - Uning Suya Emit 2000* Reag Technicaon RA® and operes Casin 2000* Reagents)

Indications For Use:

This in viro diagnostic procedure is intended to measure the concentration of digoxin in human
RA-XT-1000 million the lates and 600® Technicon RA-1000®, Technicon RA-XTTM, serum or plasma on a Technicon RA-500®, Technicon RA-1000®, Technicon RA-XTM,
serum or plasma on a Technicon RA-500®, Technicon RA-1000®, Technicon RA-XTM, secure or plasma on a Technicon RA-500®, Technicon KA-1000%, Tourned with this procedure are used
Technicon RA-2000®, or opeRA system. Measurements obtained with this proced Technicon RA-2000®, or opeRA system. Measurements obtained with the proper theraped with the maintained while avoiding toxicity.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use L (Per 21 CFR 801.109)

OR

Over-The-Counter Use_

Optional Format 1-2-96)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number GR953671