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 Description

The Stratus® CS Acute Care™ Troponin I TestPak is an in vitro immunoassay.

AI/ML Overview

Here's an analysis of the provided text regarding the Stratus® CS Acute Care™ Troponin I TestPak, focusing on acceptance criteria and supporting studies, while noting the limitations of the provided document in answering all your specific questions:

The document (K033487) describes a 510(k) premarket notification for a revised labeling of an existing device, the Stratus® CS cTnI TestPak, which is now branded as Stratus® CS Acute Care™ Troponin I TestPak. The key assertion is that the device itself is identical to the predicate, with only the insert sheet (labeling) being updated. Therefore, the "acceptance criteria" and "studies" are primarily related to the validity of the labeling changes rather than a new device proving its performance from scratch.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a labeling change for an identical device, specific "acceptance criteria" in the traditional sense (e.g., sensitivity, specificity thresholds for a novel device) are not explicitly stated for this submission. Instead, the changes in the insert sheet reflect updates based on current clinical understanding and internal/external studies. The performance of the device is implicit in its substantial equivalence to the predicate.

Here's a table summarizing the changes introduced in the revised insert sheet and the source data that supports those changes, which can be interpreted as the basis for accepting the new labeling:

Acceptance Criteria (Related to Labeling Change)	Reported Device Performance/Supporting Data
Method Name Update: Reflect the new "Acute Care" designation.	N/A: A branding/naming change.
Test Steps Clarification: Simplified presentation by implying automated steps.	N/A: A reformatting of instructions.
Interpretation of Results - Added Clinical Guidance:	1. National Academy of Clinical Biochemistry statement: Incorporated into the insert. 2. Medical history consideration: Added as a general principle of interpretation. 3. Statements moved from Diagnosis of AMI: Reorganization for clarity. 4. Institutional reference intervals & myocardial injury causes: Added for comprehensive guidance.
Reference Interval - Updated Percentiles: Use 97.5th and 99th percentiles.	Internal and external reference interval studies: These studies provided the data to support the change from 95th to 97.5th and 99th percentiles. (No specific values provided in this document).
Risk Stratification - Added ACC/AHA Definition: Incorporate current clinical guidelines.	1. Lower risk stratification concentration (0.1 ng/mL) based on recommendations from: American College of Cardiology (ACC), American Heart Association, and multiple hospital clinical studies.
Diagnosis of AMI - Added Specific Information:	1. Sensitivity/specificity graph: Added to the insert. 2. EU Society of Cardiology/ACC statement on MI definition: Incorporated into the insert.3. Functional sensitivity information at 99th percentile: Added to the insert. 4. Low-end, functional sensitivity precision studies: Indicated a high sensitivity method (underlying data for functional sensitivity).
Performance Characteristics - Added Plasma Pool Reproducibility Data:	Plasma pool reproducibility data: Added to the insert (no specific data shown in this document).
Correlation Data - Added Comparison to Predicate: Dade Behring Dimension®.	Performance comparison versus Dade Behring Dimension® clinical chemistry system: Added to the insert (no specific data shown in this document).
Recovery - Clarified Titles: Better presentation of recovery data.	N/A: A formatting change.
Bibliography - Added References: Update with current literature.	N/A: Update of references section.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" sample size in the context of a new device validation. The studies mentioned are:

"Internal and external reference interval studies"
"Low-end, functional sensitivity precision studies"
"Multiple hospital clinical studies" (related to risk stratification concentration)

The data provenance is generally described as internal and external studies, but specific countries of origin or whether they were retrospective or prospective are not detailed within this summary.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The studies referenced are laboratory performance or clinical guideline-driven, not expert adjudication of a test set in the way a diagnostic imaging AI might be evaluated.

4. Adjudication Method for the Test Set

This information is not provided, as the nature of the studies supporting the labeling changes does not involve expert adjudication of a test set in the context of diagnostic accuracy.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study is not mentioned or suggested by the document. This type of study is typical for diagnostic imaging AI, where human readers interact with the device. This submission is for an in-vitro diagnostic (IVD) assay with labeling changes, not an AI with human-in-the-loop performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is an IVD assay, which by its nature operates "standalone" in generating a numerical result. The interpretation of that result is then done by a clinician. The focus of this submission is on the labeling of this standalone result, ensuring it aligns with current clinical guidelines and reflects validated performance characteristics (like precision and reference intervals). Therefore, in a sense, the data does represent "standalone" performance, but not in the context of an "algorithm" as might be understood for AI.

7. The Type of Ground Truth Used

The "ground truth" for the information added to the labeling seems to be:

Clinical guidelines and consensus statements: From organizations like the National Academy of Clinical Biochemistry, American College of Cardiology (ACC), American Heart Association, and EU Society of Cardiology.
Internal and external study data: For reference intervals, functional sensitivity, and reproducibility. The ultimate outcome this device aids in diagnosing (Myocardial Infarction) would be confirmed by a combination of clinical presentation, ECG, and serial biomarker measurements, often with pathology (e.g., autopsy) or long-term outcomes for definitive cases, but this document focuses on the assay's performance and appropriate use.

8. The Sample Size for the Training Set

This information is not provided. The studies mentioned (e.g., "internal and external reference interval studies", "low-end, functional sensitivity precision studies") would have involved sample sizes, but they are not detailed in this summary.

9. How the Ground Truth for the Training Set Was Established

This information is not provided. For reference interval studies, "ground truth" would typically mean carefully selected healthy populations and/or patient cohorts. For functional sensitivity, it involves spiking known concentrations and evaluating analytical performance. The document points to these types of studies but does not detail their methodology or how their "ground truth" (i.e., the true state or value) was established.

Summary

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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. PlummerDade Behring Inc.P.O. Box 6101Newark, 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:

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(throughout insert sheet)	Stratus® CS Acute Care™ Troponin I
Test Steps	Clarification of steps performed automatically allowed removal ofResults section
Interpretation of Results	1. Added National Academy of Clinical Biochemistry statement2. Added statement on results interpretation in conjunction withmedical history3. Moved some statements from the Diagnosis of AMI section4. Added statements on institutions establishing own referenceinterval and other conditions which can led to myocardial injury
Reference Interval	Presentation of 97.5th and 99th percentile results instead of the 95thpercentile
Risk Stratification	Added American College of Cardiology (ACC)/AHA definition forshort term risk of death/non-fatal MI
Diagnosis of AMI	1. Added sensitivity/specificity graph2. Added EU Society of Cardiology/ACC statement on MIdefinition3. Added functional sensitivity information at 99th percentile
PerformanceCharacteristics	Added plasma pool reproducibility data
Correlation Data	Added performance comparison versus Dade Behring Dimension®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.
1. Internal and external reference interval studies provided the stated 97.5th and 99th percentiles
1. 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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Page 2 -

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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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:

(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

Regulation Number and Section

§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.

(a)
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.(b)
Classification. Class II.