DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY

K972782 · Dade Intl., Inc. · JHX · Aug 15, 1997 · Clinical Chemistry

Device Facts

• Record ID: K972782
• Device Name: DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
• Applicant: Dade Intl., Inc.
• Product Code: JHX · Clinical Chemistry
• Decision Date: Aug 15, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Indications for Use

Measurements of creatine kinase MB isoenzyme are used in the diagnosis and treatment of myocardial infaction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Device Story

The Stratus® CK-MB Fluorometric Enzyme Immunoassay is an in vitro diagnostic test for the MB isoenzyme of creatine kinase. It processes human serum or heparinized plasma samples on Stratus®, Stratus® II, or Stratus® IIntellect analyzers. The device utilizes fluorometric enzyme immunoassay technology to quantify CK-MB levels. It is intended for use in clinical laboratory settings by trained personnel. The output provides quantitative CK-MB concentrations, which assist clinicians in diagnosing and monitoring myocardial infarction and specific muscle diseases. No modifications to configuration or formulation were made for this submission; the device maintains the same operational principle as previously cleared versions, with the scope expanded to include heparinized plasma.

Clinical Evidence

A comparative study was conducted to validate the use of heparinized plasma against the predicate serum sample type. The study analyzed 160 samples, yielding a slope of 1.17, an intercept of 1.6, and a correlation coefficient of 0.976 over a concentration range of 0 to 113.1 ng/mL.

Technological Characteristics

Fluorometric enzyme immunoassay; designed for use on Stratus®, Stratus® II, and Stratus® IIntellect analyzer platforms. Analyzes human serum and heparinized plasma samples.

Indications for Use

Indicated for the diagnosis and treatment of myocardial infarction and muscle diseases, including progressive Duchenne-type muscular dystrophy, in patients requiring CK-MB isoenzyme measurement.

Regulatory Classification

Identification

A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Submission Summary (Full Text)

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K972782
Aug 15, 1997
**DADE INTERNATIONAL**

Chemistry Systems P.O. Box 6101 Newark, DE 19714

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® CK-MB Fluorometric Enzyme Immunoassay

Summary of Safety and Effectiveness

The Dade Stratus® CK-MB Fluorometric Enzyme Immunoassay is an in vitro diagnostic test for the MB isoenzyme of creatine kinase. The assay can be processed on the Stratus® analyzer, the Stratus® II analyzer or the Stratus® IIntellect analyzer.

The Stratus® CK-MB Fluorometric Enzyme Immunoassay has been cleared by the Food and Drug Administration, via its 510(k) process, for use with human serum samples. This submission supports expansion of the sample type to include human heparinized plasma samples. There have been no modifications in configuration or formulation to the Stratus® CK-MB Fluorometric Enzyme Immunoassay.

A comparison study between serum and heparinized plasma samples was conducted with the following results:

| | Slope | Intercept | Correlation<br>Coefficient | Range of<br>Samples |
|--------------------------------|-------|-----------|----------------------------|---------------------|
| Serum/Plasma<br>(n = 160 rats) | 1.17 | 1.6 | 0.976 | 0 - 113.1 ng/mL |

Carolyn K. George

Carolyn K. George Regulatory Affairs and Compliance Manager

July 23, 1997
Date

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AUG 1 5 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Carolyn K. George Requlatory Affairs and Compliance Manager -Dade International Post Office Box 6101 Newark, DE 19714

K972782 Re: Stratus® CK-MB Fluorometric Enzyme Immunoassay Regulatory Class: II Product Code: JHX Dated: July 24, 1997 Received: July 25, 1997

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, 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 requlation (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 marress 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

Device Name: Stratus® CK-MB Fluorometric Enzyme Immunoassay

Indications for Use: Measurements of creatine kinase MB isoenzyme are used in the diagnosis and treatment of myocardial infaction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Audrey K. George

arolyn K. George Regulatory Affairs and Compliance Manager

July 23 1997
Date

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ✓
(Per 21 CFR 801. 109)

K972782

510(k) Number

Ablagman Lee R. Montgomery
Division Sign Off
Office of Device Evaluation

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