STRATUS CS MYOGLOBIN (MYO) TESTPAK

K981102 · Dade Behring, Inc. · DDR · Apr 27, 1998 · Immunology

Device Facts

• Record ID: K981102
• Device Name: STRATUS CS MYOGLOBIN (MYO) TESTPAK
• Applicant: Dade Behring, Inc.
• Product Code: DDR · Immunology
• Decision Date: Apr 27, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5680
• Device Class: Class 2

Intended 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.

Device Story

The MYO TestPak is an in vitro diagnostic assay for measuring myoglobin levels in heparinized plasma. It operates on the Stratus® CS STAT fluorometric analyzer using Radial Partition Immunoassay (RPIA) technology. The device performs a two-site sandwich assay where the enzymatic rate of the bound fraction increases proportionally to the myoglobin concentration. An optical system monitors the reaction rate via front surface fluorescence. The system is intended for clinical laboratory use to assist healthcare providers in diagnosing renal or heart disease, such as acute myocardial infarction. Results are used by clinicians to inform diagnostic decisions.

Clinical Evidence

Bench testing only. A split-sample comparison study was conducted between the Stratus® CS STAT analyzer and the predicate Dade Stratus® analyzer using 203 samples ranging from 15 to 829 ng/mL. Results showed a correlation coefficient of 0.987, a slope of 0.97, and an intercept of 8.

Technological Characteristics

In vitro diagnostic assay; Radial Partition Immunoassay (RPIA) technology; two-site sandwich assay; front surface fluorescence detection; automated system; heparinized plasma sample matrix.

Indications for Use

Indicated for the measurement of myoglobin in heparinized plasma as an aid in the rapid diagnosis of renal or heart disease, including 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

• Dade Stratus® analyzer (K981102)

Submission Summary (Full Text)

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## DADE BEHRING

APR 27 1998

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

## Stratus® CS MYO TestPak

## Summary of Safety and Effectiveness

The MYO TestPak used on the Stratus® CS STAT fluorometric analyzer is an in vitro diagnostic test for the measurement of myoglobin.

This myoglobin assay is a two-site sandwich assay based upon solid phase Radial Partition Immunoassay (RPIA) technology. 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.

The myoglobin assay performed with the MYO TestPak is substantially equivalent to the myoglobin assay performed on the Dade Stratus® analyzer, which was cleared by the FDA through the 510(k) process. Both methodologies have intended uses and are processed on automated systems which use a fluorescence detection for the determination of myoglobin.

A split sample comparison study was conducted between the two systems with the following results:

| n | Slope | Intercept | Correlation Coefficient |
|-----|-------|-----------|-------------------------|
| 203 | 0.97 | 8 | 0.987 |

Samples 15 - 829 ng/ mL

Range of

Carolyn K. Henge

Carolyn K. George Regulatory Affairs and Compliance Manager

March 25, 1998

Date

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 2 7 1998

Carolyn K. George . Regulatory Affairs and Compliance Manager Dade Behring Inc. P.O. Box 6101 Newark, Delaware 19714

Re : K981102 Stratus® CS Myoglobin (MYO) TestPak Requlatory Class: II Product Code: DDR Dated: March 25, 1998 March 26, 1998 Received:

Dear Ms. George:

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 registration, listing of devices, qood 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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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 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 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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## Indications Statement

Stratus® CS Myoglobin (MYO) TestPak Device Name:

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.

Carolyn K. Henge

Carolyn K. George Regulatory Affairs and Compliance Manager

March 25, 1998

Date

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

K981102

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510(k) Number

310(k) Number

Division Sign-Off

Division Sign-Off Office of Device Evaluation

prescription use

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