(32 days)
The TROP TestPak used on the Stratus® CS STAT fluorometric analyzer is an in vitro diagnostic product for the measurement of cardiac troponin I in heparinized plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
The Cardiac Troponin I (TROP) TestPak used on the Stratus® CS STAT fluorometric analyzer is an in vitro diagnostic test for the measurement of cardiac troponin I. This troponin 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 cardiac troponin I in the sample. The reaction rate is measured by an optical system that monitors the reaction rate via front surface fluorescence.
The Dade Behring Inc. Stratus® CS Cardiac Troponin I TestPak is an in vitro diagnostic test for the measurement of cardiac troponin I, used in the diagnosis and treatment of myocardial infarction and to aid in risk stratification for acute coronary syndromes.
Here's the analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for substantial equivalence are based on a split-sample comparison study against a predicate device. The primary metrics are slope, intercept, and correlation coefficient.
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance |
|---|---|
| Slope close to 1.0 | 0.90 |
| Intercept close to 0.0 | 0.12 |
| Correlation Coefficient close to 1.0 | 0.988 |
| Range of Samples covered by the study | 0.0 - 43.30 ng/mL |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 211 samples.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It is a "split sample comparison study," which implies prospective collection where a single patient sample is split and run on two different devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided. For this type of in vitro diagnostic device assessing a biomarker level, the "ground truth" is typically defined by the reference method or predicate device's performance, rather than expert interpretation of results. The study compares the new device's measurements directly to those of the predicate device.
4. Adjudication Method for the Test Set
Not applicable. The study is a quantitative comparison of measurements between two devices, not an interpretive assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is an in vitro diagnostic device measuring a biomarker, not an imaging or interpretive device that would involve multiple human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this is an inherent standalone performance study. The TROP TestPak on the Stratus® CS STAT analyzer independently measures cardiac troponin I concentrations. The study directly compares the results of this standalone measurement against another standalone device (the predicate Stratus® analyzer).
7. The Type of Ground Truth Used
The "ground truth" for this study is the measurement obtained from the predicate device, the cardiac troponin I assay performed on the Dade Stratus® analyzer. This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices, where the new device's performance is compared to an already cleared and validated method.
8. The Sample Size for the Training Set
This information is not provided. The document describes a comparison study for regulatory clearance, not the development or training of the assay itself. The assay is a "two-site sandwich assay based upon solid phase Radial Partition Immunoassay (RPIA) technology," which is a chemical/biological method, not a machine learning algorithm that typically requires a training set in the same sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable in the context of the provided document. As mentioned above, this is a chemical/biological assay, not a machine learning model. The development of such an assay involves extensive analytical validation, but the concept of a "training set" and "ground truth" for it differs significantly from that for, say, an AI imaging algorithm.
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DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714
1981098 DADE BEHRING
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 Cardiac Troponin I TestPak
Summary of Safety and Effectiveness
The Cardiac Troponin I (TROP) TestPak used on the Stratus® CS STAT fluorometric analyzer is an in vitro diagnostic test for the measurement of cardiac troponin I.
This troponin 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 cardiac troponin I in the sample. The reaction rate is measured by an optical system that monitors the reaction rate via front surface fluorescence.
The cardiac troponin I assay performed with the TROP TestPak is substantially equivalent to the cardiac troponin I assay performed on the Dade Stratus® analyzer, which was cleared by the FDA through the 510(k) process. Both methodologies are processed on automated systems, use the same source antibodies and have a fluorometric detection system.
A split sample comparison study was conducted between the two systems with the following results:
| n | Slope | Intercept | CorrelationCoefficient | Range ofSamples |
|---|---|---|---|---|
| 211 | 0.90 | 0.12 | 0.988 | 0.0 - 43.30 ng/mL |
Carolyn K. George
Carolyn K. George Regulatory Affairs and Compliance Manager
March 25, 1998
Date
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an emblem that features a stylized image of an eagle with three human profiles incorporated into its design.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 27 1998
Carolyn K. George Regulatory Affairs and Compliance Manager Dade Behring Inc. P.O. Box 6101 Newark, Delaware 19714
Re : K981098 Stratus® CS Cardiac Troponin I (TROP) TestPak Regulatory Class: II Product Code: MMI March 25, 1998 Dated: Received: March 26, 1998
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 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 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 (770) 488-7655.
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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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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Stratus® CS Cardiac Troponin I (TROP) TestPak Device Name:
Indications for Use: The TROP TestPak used on the Stratus® CS STAT fluorometric analyzer is an in vitro diagnostic product for the measurement of cardiac troponin I in heparinized plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
Carolyn K. George
Carolyn K. George Regulatory Affairs and Compliance Manager
March 25, 1998
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§ 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.