STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI

K033487 · Dade Behring, Inc. · MMI · Dec 24, 2003 · Clinical Chemistry

Device Facts

• Record ID: K033487
• Device Name: STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI
• Applicant: Dade Behring, Inc.
• Product Code: MMI · Clinical Chemistry
• Decision Date: Dec 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

The Stratus® CS Acute Care™ Troponin I method is an in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used as an aid in the diagnosis of myocardial infarction. Cardiac troponin I can also be used as an aid in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.

Device Story

The Stratus® CS Acute Care™ Troponin I TestPak is an in vitro diagnostic immunoassay used to measure cardiac troponin I levels in heparinized plasma. The device functions as a test kit for use on the Stratus® CS clinical chemistry system. It automates the measurement process to provide quantitative results. Healthcare providers use these results in conjunction with clinical history to diagnose myocardial infarction and stratify the mortality risk of patients presenting with acute coronary syndromes. The device is intended for professional use in clinical settings.

Clinical Evidence

Evidence includes internal and external reference interval studies establishing 97.5th and 99th percentiles, precision studies confirming high functional sensitivity, and performance correlation data against the Dade Behring Dimension® clinical chemistry system. Data supports the updated labeling for AMI diagnosis and risk stratification.

Technological Characteristics

Sandwich-type immunofluorometric assay. Components: test pack with two wet reagents (buffers, anti-Troponin I antibodies), wash buffer with indicator substrate, glass fiber paper substrate. Immobilization: dendrimer-linked monoclonal anti-TnI antibody. Indicator: alkaline phosphatase-labeled antibody. Energy source: automated analyzer (Dade Stratus® CS STS). Connectivity: standalone analyzer.

Indications for Use

Indicated for patients with suspected myocardial infarction or acute coronary syndromes to aid in diagnosis and risk stratification for mortality. For use with heparinized plasma samples.

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.

Predicate Devices

• Stratus® CS STAT cardiac Troponin I assay (K984093)
• Stratus® CS STAT cardiac Troponin I assay (K981098)

Reference Devices

• Dade Behring Dimension® clinical chemistry system

Submission Summary (Full Text)

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K033487

# DEC 2 4 2003

## Summary of Safety and Effectiveness Information

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

| Submitter's Name: | George M. Plummer<br>Dade Behring Inc.<br>P.O. Box 6101<br>Newark, DE 19714-6101 |
|--------------------------|----------------------------------------------------------------------------------|
| Date of Preparation: | October 31, 2003 |
| Name of Product: | Stratus® CS ™ Troponin I TestPak |
| FDA Classification Name: | Immunoassay Method, Troponin Subunit |
| Predicate Device: | Dade Behring Stratus® CS cTnI TestPak(K984093/K981098) |

#### Intended Use:

The Stratus® CS Acute Care™ Troponin I method is an in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used as an aid in the diagnosis of myocardial infarction. Cardiac troponin I can also be used as an aid in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.

## Comparison to Predicate Device:

The Stratus® CS Acute Care™ Troponin I TestPak is substantially equivalent in intended use, principle and performance to the current Dade Behring Stratus® CS cTnI TestPak. Both assays are in vitro immunoassays with an intended use as an aid in the diagnosis of acute myocardial infarction and risk stratification of patients with acute coronary syndrome.

There are no formulation or design changes associated with the Stratus® CS cTnI TestPak labeling change. The two products are identical and use the same manufacturing processes. Only the insert sheets contain different information. The table on the next page summarizes the changes in the revised product insert sheet.

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| Item | Revised Insert Sheet Change |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Method Name<br>(throughout insert sheet) | Stratus® CS Acute Care™ Troponin I |
| Test Steps | Clarification of steps performed automatically allowed removal of<br>Results section |
| Interpretation of Results | 1. Added National Academy of Clinical Biochemistry statement<br>2. Added statement on results interpretation in conjunction with<br>medical history<br>3. Moved some statements from the Diagnosis of AMI section<br>4. Added statements on institutions establishing own reference<br>interval and other conditions which can led to myocardial injury |
| Reference Interval | Presentation of 97.5th and 99th percentile results instead of the 95th<br>percentile |
| Risk Stratification | Added American College of Cardiology (ACC)/AHA definition for<br>short term risk of death/non-fatal MI |
| Diagnosis of AMI | 1. Added sensitivity/specificity graph<br>2. Added EU Society of Cardiology/ACC statement on MI<br>definition<br>3. Added functional sensitivity information at 99th percentile |
| Performance<br>Characteristics | Added plasma pool reproducibility data |
| Correlation Data | Added performance comparison versus Dade Behring Dimension®<br>clinical chemistry system |
| Recovery | Clarified titles in chart |
| Bibliography | Added references |

The source data used to support the insert sheet changes is listed below:

- 1. The lower risk stratification concentration for 0.1ng/mL is based on recommendations from the American College of Cardiology (ACC), American Heart Association and multiple hospital clinical studies.
- 2. Internal and external reference interval studies provided the stated 97.5th and 99th percentiles
- 3. Low-end, functional sensitivity precision studies indicate a high sensitivity method

#### Conclusion:

The Stratus® CS Acute Care™ Troponin I TestPak is substantially equivalent in principle and performance to the current Dade Behring Stratus® CS cTnI TestPak

George M. Plummer Regulatory Affairs and Compliance Manager October 31, 2003

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three human figures inside, representing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 4 2003

Mr. George M. Plummer Affairs & Compliance Manager Dade Behring, Inc. Chemistry/Immunochemistry Glasgow Business Community P.O. Box 6101 - Bldg. 500 Newark, DE 19714

k033487 Re:

Trade/Device Name: Stratus® CS Acute Care™ Troponin I TestPak Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: MMI Dated: October 31, 2003 Received: November 21, 2003

Dear Mr. Plummer:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications For Use Statement

510(k) Number (if known): K 033487

#### Device Name:

Stratus® CS Acute Care™ Troponin I TestPak

#### Indications for Use:

The Stratus® CS Acute Care™ Troponin I method is an in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used as an aid in the diagnosis of myocardial infarction. Cardiac troponin I can also be used as an aid in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) L Over-The-Counter Use Prescription Use OR (Optional Format 1-2-96) (Per 21 CRF 801.109) Division Sign-Off

> Office of In Vitro Diagnost. J. J. Evaluation and Safety

510(k) 1033487