STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK

K984065 · Dade Behring, Inc. · DDR · Dec 14, 1998 · Immunology

Device Facts

• Record ID: K984065
• Device Name: STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK
• Applicant: Dade Behring, Inc.
• Product Code: DDR · Immunology
• Decision Date: Dec 14, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5680
• Device Class: Class 2

Intended Use

The Myoglobin (MYO) TestPak used on the Stratus® CS STAT Fluorometric Analyzer is an in vitro diagnostic product for the measurement of myoglobin in heparinized plasma. Measurements of myoglobin are used as aids in the rapid diagnosis of renal and heart disease, e.g. acute myocardial infarction.

Device Story

The Stratus® CS Myoglobin (MYO) TestPak is a plastic cartridge containing glass fiber paper for use with the Stratus® CS STAT Fluorometric Analyzer. It utilizes a two-site sandwich Radial Partition Immunoassay (RPIA). The process involves: adding heparinized plasma to the glass fiber paper containing immobilized anti-myoglobin antibody; adding enzyme-labeled antibody to form an antibody-antigen-labeled antibody sandwich; and eluting unbound labeled antibody using a substrate wash solution. The analyzer's optical system monitors the enzymatic reaction rate via front surface fluorescence. Data analysis is performed by the analyzer's internal microprocessor. The device is used in clinical laboratory settings to provide rapid diagnostic results for renal and heart disease, assisting physicians in clinical decision-making for conditions like acute myocardial infarction.

Clinical Evidence

Bench testing only. Data provided supports the modification of the recommended quality control frequency from daily to weekly, demonstrating that the change does not adversely affect device performance.

Technological Characteristics

Two-site sandwich Radial Partition Immunoassay (RPIA) on glass fiber paper. Measurement is fluorometric. The device is a plastic cartridge with five wells. Data analysis is performed by an internal microprocessor within the Stratus® CS STAT Fluorometric Analyzer.

Indications for Use

Indicated for the quantitative measurement of myoglobin in heparinized plasma to aid in the rapid diagnosis of renal and heart disease, such as acute myocardial infarction.

Regulatory Classification

Identification

A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.

Predicate Devices

• Stratus® CS Myoglobin (MYO) TestPak (K981102)

Submission Summary (Full Text)

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# Dade Behring

DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714

#### Summary of Safety and Effectiveness Information

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| Submitter's Name: | Rebecca S. Ayash<br>Dade Behring Inc.<br>Building 500, Mailbox 514<br>P.O. Box 6101<br>Newark, DE 19714-6101 |
|----------------------|--------------------------------------------------------------------------------------------------------------|
| Date of Preparation: | 11/6/98 |
| Device Name: | Stratus® CS Myoglobin (MYO) TestPak |
| Classification Name: | Myoglobin Immunological Test System |
| Predicate Device: | Stratus® CS Myoglobin (MYO) TestPak (K981102) |

Device Description: The MYO TestPak consists of a plastic cartridge with five wells and a small square of glass fiber paper embedded in it. The method utilizes a two-site sandwich assay based upon solid phase Radial Partition Immunoassay (RPIA) technology. In this procedure, dendrimer linked monoclonal antibody is added to the center portion of a square piece of glass fiber paper in the MYQ TestPak. Sample is then added onto the paper where it reacts with the immobilized anti-myoglobin antibody. After a short incubation, a conjugate consisting of enzyme-labeled antibody directed against a distinct antigenic site on the myoglobin molecule is pipetted onto the reaction zone of the paper. During this second incubation period, enzymelabeled antibody reacts with the bound myoglobin, forming an antibody-antigen-labeled antibody sandwich. The unbound labeled antibody is later eluted from the field of view of the Stratus® CS analyzer by applying a substrate wash solution to the center of the reaction zone of the TestPak. By including substrate for the enzyme within the wash solution, initiation of enzyme activity occurs simultaneously with the wash. The enzymatic rate of the bound fraction increases directly with the concentration of myoglobin in the sample. The reaction rate is measured by an optical system that monitors the reaction rate via front surface fluorescence. All data analysis functions are performed by the microprocessor within the analyzer.

This device was previously cleared under K981102. Subsequently, the product insert has been modified to change the recommended frequency of quality control from daily to weekly.

Intended Use: The Myoglobin (MYO) TestPak used on the Stratus® CS STAT Fluorometric Analyzer is an in vitro diagnostic product for the measurement of myoglobin in heparinized plasma. Measurements of myoglobin are used as aids in the rapid diagnosis of renal and heart disease, e.g. acute myocardial infarction.

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#### Comparison to Predicate Device:

| Feature | Stratus CS® MYO (modified) | Stratus CS® MYO (K981102) |
|--------------------------|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Principle of procedure | Two-site sandwich assay | Two-site sandwich assay |
| Type of measurement | Fluorometric | Fluorometric |
| Solid Phase | Glass fiber paper | Glass fiber paper |
| Sample Type | Heparinized plasma | Heparinized plasma |
| Recommended QC Frequency | At least once each week | At least daily |
| Intended Use | For the quantitative<br>measurement of myoglobin | For the quantitative<br>measurement of myoglobin |
| Indications for Use | For use as an aid in the rapid<br>diagnosis of renal and heart<br>disease, e.g. acute myocardial<br>infarction | For use as an aid in the rapid<br>diagnosis of renal and heart<br>disease, e.g. acute myocardial<br>infarction |

#### Comments on Substantial

Equivalence: Both assays are in vitro immunoassays with intended uses for the measurement of Myoglobin in heparinized plasma. The modified device differs from the device cleared under K981102 only in the recommended QC frequency in product labeling.

Conclusion: The QC data collected supports the recommended change in QC frequency and indicates the change will not adversely affect performance of the device.

Rebecca S. Apsh

Rebecca S. Ayash Regulatory Affairs and Compliance Manager Date: 11/13/98

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The logo is black and white.

DEC T 4 1998

Ms. Rebecca S. Ayash Requlatory Affairs and Compliance Manager Dade Behring Building 500, Mailbox 514 P.O. Box 6101 Newark, Delaware 19714-6101

Re: K984065 Stratus® CS Myoglobin (MYO) TestPak Trade Name: Requlatory Class: II Product Code: DDR Dated: November 13, 1998 Received: November 16, 1998

Dear Ms. Ayash:

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 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 requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq 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 Reqister. 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.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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Page 2

This letter will allow you to beqin 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 requlation (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 requlation 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/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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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## Indications Statement

Device Name: Stratus® CS Myoglobin (MYO) TestPak

Indications for Use: The MYO TestPak used on the Stratus® CS STAT Fluorometric Analyzer is an in vitro diagnostic product for the measurement of Myoglobin in heparinized plasma. Measurements of Myoglobin are used as aids in the rapid diagnosis of renal or heart disease, e.g. acute myocardial infarction.

Rebecca S. Ayashi

Rebecca S. Ayash Regulatory Affairs and Compliance Manager Date: 11/13/98

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Concurrence of CDRH, Office of Device Evaluation (ODE)

K9840i5
510(k) Number

510(k) Number

Division Sign-Off Office of Device Evaluation

prescription use

(Division Sign-Off)
Division of Clinical Laborator
510(k) Number. k984065