N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM

K971713 · Bayer Corp. · LAN · Jun 11, 1997 · Clinical Toxicology

Device Facts

• Record ID: K971713
• Device Name: N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
• Applicant: Bayer Corp.
• Product Code: LAN · Clinical Toxicology
• Decision Date: Jun 11, 1997
• 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 N-acetylprocainamide, an antiarrhythmic drug, in human serum or plasma (lithium heparin) using EMIT* (Enzyme Multiplied Immunoassay Technique) technology on a Bayer Immuno I™ system. Measurements of N-acetylprocainamide are used in the diagnosis and treatment of procainamide overdose and in monitoring serum or plasma levels of N-acetylprocainamide to ensure appropriate therapy. This diagnostic method is not intended for use on any other system.

Device Story

In vitro diagnostic assay for quantitative measurement of N-acetylprocainamide (NAPA) in human serum or plasma; utilizes Enzyme Multiplied Immunoassay Technique (EMIT) on Bayer Immuno 1 system; intended for clinical laboratory use to monitor therapeutic levels and manage procainamide overdose; provides concentration values to clinicians for therapeutic decision-making.

Clinical Evidence

Bench testing only. Performance compared to predicate using 99 samples. Correlation: y = 0.99x - 0.03, r = 0.99, Syx = 0.29 µg/mL. Precision (total) reported at 5.5% @ 1.7 µg/mL, 4.3% @ 4.2 µg/mL, and 6.5% @ 8.7 µg/mL. Minimum detectable concentration: 0.11 µg/mL.

Technological Characteristics

In vitro diagnostic immunoassay using EMIT technology. Designed for use on Bayer Immuno 1 system. Analyte: N-acetylprocainamide. Sample matrix: human serum or plasma (lithium heparin).

Indications for Use

Indicated for quantitative measurement of N-acetylprocainamide in human serum or plasma to assist in diagnosis/treatment of procainamide 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® N-Acetylprocainamide Assay

Submission Summary (Full Text)

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## SUMMARY OF SAFETY AND EFFECTIVENESS

## N-Acetylprocainamide Assay for Bayer Immuno 1° System

Listed below is a comparison of the performance between the Immuno 1 N-Acetylprocainamide (NAPA) assay and a Elsstor of a confed is a confed clearance of substantial equivalence (Syva EMIT® N-Acetylprocainamide Assay, Behring Diagnostics Inc.). The information used in the Summary of Safety and Effectiveness was extracted from the Immuno I N-Acetylorocainamide Method Sheet and the Syva EMIT® N-Acetylprocainamide Assay Insert Sheet.

## INTENDED USED

This in vitro method is intended to quantitatively measure n-acetylprocainamide, the pharmacologically active meabolite for procainamide, an antiarrhythmic drug, in human serum or plasma (lithium heparin) using Syva EMIT® N-Acetylprocainamide Assay on a Bayer Immuno-1 system. Measurements of n-acetylprocainamide are used in the diagnosis and treatment of procainamide overdose and in monitoring levels of n-acetylprocainanide to ensure appropriate therapy.

| METHOD | Immuno 1 NAPA Assay | Syva EMIT® NAPA Assay<br>(predicate Device) |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Part No. | T01-3990-51 | 4N024UL |
| Minimum Detectable Conc. | 0.11 µg/mL | 0.25 µg/mL |
| Precision | (Total)<br>5.5% @ 1.7 µg/mL<br>4.3% @ 4.2 µg/mL<br>6.5% @ 8.7 µg/mL | (Between-Run)<br>3.9% @ 1.7 µg/mL<br>4.5% @ 4.5 µg/mL<br>4.5% @ 10.8 µg/mL |
| Correlation | y = 0.99x - 0.03<br>where<br>y = Immuno 1 N-Acetylprocainamide Assay<br>x = Syva EMIT® N-Acetylprocainamide Assay*<br>n = 99<br>r = 0.99<br>Syx = 0.29 µg/mL | |

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

Gabriel J. Murray, Jr.

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

ﺳﮯ

5/7/97

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Date

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 111 1997

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

K971713 Re :

N-Acetylprocainamide Assay for the Bayer Immuno 1™ System 发 Regulatory Class: II Product Code: LAN 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 The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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 requlations.

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Paqe 2

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 diaqnostic 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 1 of 1

510(k) Number (if known):

N-Acetylprocainamide (NAPA) Device Name:_

Indications For Use:

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

## T WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF

| | Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|------------------------------------------|--------------------------------------------------------|--------------------------|
| | (Division Sign-Off) | |
| | Division of Clinical Laboratory Devices | |
| 510(k) Number | K171713 | |
| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
| | | (Optional Format 1-2-96) |