PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM

K971716 · Bayer Corp. · LAR · Jun 27, 1997 · Clinical Toxicology

Device Facts

• Record ID: K971716
• Device Name: PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
• Applicant: Bayer Corp.
• Product Code: LAR · Clinical Toxicology
• Decision Date: Jun 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3320
• Device Class: Class 2

Intended Use

This in viro method is intended to quantitatively measure procainamide, an antiarrhythmic drug, in human serum or plasma (lithium heparin) using Syva EMIT® Procainamide Assay on a Bayer Immuno-19 system. Measurements of procainamide are used in the diagnosis and treatment of procainamide overdose and in monitoring levels of procainamide to ensure appropriate therapy.

Device Story

In vitro diagnostic assay for quantitative measurement of procainamide in human serum or plasma; utilizes EMIT (Enzyme Multiplied Immunoassay Technique) technology on Bayer Immuno 1 system; intended for clinical laboratory use to monitor therapeutic drug levels and manage overdose; provides concentration data to clinicians for treatment adjustment; benefits patients by ensuring optimal therapeutic dosing and identifying toxic levels.

Clinical Evidence

Bench testing only. Comparison study (n=99) between Immuno 1 Procainamide Assay and predicate Syva EMIT® assay on COBAS FARA II. Correlation results: y = 0.95x + 0.24, r = 0.99, Syx = 0.27 µg/mL. Precision (total) for Immuno 1: 3.1% at 2.0 µg/mL, 4.1% at 7.6 µg/mL, 7.0% at 9.4 µg/mL.

Technological Characteristics

In vitro diagnostic assay using EMIT (Enzyme Multiplied Immunoassay Technique). Designed for use on Bayer Immuno 1 system. Measures procainamide in human serum or plasma (lithium heparin).

Indications for Use

Indicated for quantitative measurement of procainamide in human serum or plasma (lithium heparin) for diagnosis/treatment of overdose and therapeutic drug monitoring.

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

• Syva EMIT® Procainamide Assay (Behring Diagnostics Inc.)

Reference Devices

• COBAS FARA II® Instrument

Submission Summary (Full Text)

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# JUN 27 1997

### SUMMARY OF SAFETY AND EFFECTIVENESS

#### Procainamide Assay for Bayer Immuno 1 System

Listed below is a comparison of the performance between the Immuno 1 Procainamide assay and a similar device that was granted clearance of substantial equivalence (Syva EMIT® Procainamide Assay, Behring Diagnostics Inc.). The information used in the Summary of Safety and Effectiveness was extracted from the Immuno 1 Procainanide Method Sheet and the Syva EMIT® Procainamide Assay Insert Sheet.

#### INTENDED USED

This in viro method is intended to quantitatively measure procainamide, an antiarrhythmic drug, in human serum or plasma (lithium heparin) using Syva EMIT® Procainamide Assay on a Bayer Immuno-19 system. Measurements of procainamide are used in the diagnosis and treatment of procainamide overdose and in monitoring levels of procainamide to ensure appropriate therapy.

| METHOD | Immuno 1 Procainamide Assay | Syva EMIT® Procainamide Assay<br>(predicate Device) |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Part No. | T01-3988-51 | 4K024UL |
| Minimum Detectable Conc. | 0.53 µg/mL | 0.25 µg/mL |
| Precision | (Total)<br>3.1% @ 2.0 µg/mL<br>4.1% @ 7.6 µg/mL<br>7.0% @ 9.4 µg/mL | (Between-Run)<br>2.5% @ 2.4 µg/mL<br>3.0% @ 5.7 µg/mL<br>4.2% @ 9.7 µg/mL |
| Correlation | y = 0.95x + 0.24<br><br>where<br>y = Immuno 1 Procainamide Assay<br>x = Syva EMIT® Procainamide Assay*<br>n = 99<br>r = 0.99<br>Syx = 0.27 µg/mL | |

*This assay was performed on COBAS FARA II® Instrument using parameters and protocol specified in Behring Application Sheet.

Gabriel J. Muraca, Jr.
Gabriel J. Muraca, Jr.

Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097

5/7/97

Date

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## JUN 27 1997

Gabriel J. Muraca, Jr. Manager Requlatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097

Re : K971716 Procainamide Assay for the Bayer Immuno 1™ System Requlatory Class: II Product Code: LAR Dated: May 7, 1997 Received: May 9, 1997

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 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 requirement, 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 requlatory 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 Requlations.

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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 Butman

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):

Procainamide (PROC) Device Name:

Indications For Use:

This in vitro diagnostic procedure is intended to quantitatively measure procainamide, an antiarrhythmic drug, in human serum or plasma (lithium heparin) using EMIT* (Enzyme Multiplied Immunoassay Technique) technology on a Bayer Immuno 17M system. Measurements of procainamide are used in the diagnosis and treatment of procainamide overdose and in monitoring serum or plasma levels of procainamide to ensure appropriate therapy. This diagnostic method is not intended for use on any other system.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|---------------------------------|---------|
| Division of Clinical Laboratory | |
| 510(k) Number | K971716 |

| Prescription Use: (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|----------------------------------------|----|--------------------------|
| | | (Optional Format 1-2-96) |