(21 days)
The TROP CalPak is an in vitro diagnostic product used to calibrate the cardiac troponin I method on the Stratus® CS STAT fluorometric analyzer. This calibrator is a device intended to establish a point of reference that is used in the determination of troponin I values.
The Stratus® CS TROP CalPak is an in vitro diagnostic product used to calibrate the cardiac troponin I method on the Stratus® CS STAT fluorometric analyzer. The TROP CalPak is a buffered bovine protein matrix product with cardiac troponin I at an approximate concentration of 45 ng/mL. The CalPak is a plastic cartridge which contains the calibrator material in reagent wells.
This document is a 510(k) premarket notification for the "Stratus® CS TROP CalPak" from Dade Behring. It is a calibrator for an in-vitro diagnostic product, and the information provided does not describe a clinical study of device performance in the way a medical AI/ML device would be evaluated. Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for an AI/ML device is not applicable to this submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific clinical performance acceptance criteria (e.g., sensitivity, specificity, accuracy) or test results are provided in the document. This is because the device is a calibrator, not a diagnostic device with performance metrics like those for detecting diseases. Its "performance" would relate to its ability to accurately calibrate the Stratus® CS STAT fluorometric analyzer for cardiac troponin I measurements.
The document states:
- "The TROP CalPak is a buffered bovine protein matrix product with cardiac troponin I at an approximate concentration of 45 ng/mL."
- "The TROP CalPak is substantially equivalent to the Stratus® troponin I calibrator as they are both intended to be used as calibrators for similar cardiac troponin I methods."
The acceptance criteria for a calibrator would typically relate to its stability, homogeneity, and its ability to achieve intended calibration within the specified range for the analyzer. However, these details are not provided in this regulatory summary.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable to this type of device. There isn't a "test set" of patient data in the context of clinical AI/ML studies. The evaluation of a calibrator would likely involve internal testing by the manufacturer to ensure it performs its function correctly with the associated analyzer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. Ground truth, in the context of AI/ML, refers to a definitive diagnosis or measurement. For a calibrator, its "ground truth" is its precisely manufactured concentration of troponin I, which is established during its production and quality control.
4. Adjudication Method for the Test Set:
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, this type of study is not relevant for a diagnostic calibrator. MRMC studies are used to evaluate the impact of a diagnostic tool (often AI/ML) on human readers' performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. The Stratus® CS TROP CalPak is a physical calibrator, not an algorithm.
7. The Type of Ground Truth Used:
For a calibrator, the "ground truth" would be the known, manufactured concentration of cardiac troponin I within the calibrator material (stated as "approximate concentration of 45 ng/mL"). This concentration is established by the manufacturer through rigorous analytical methods (e.g., gravimetric preparation, reference methods).
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
Summary Relevant to the Document's Purpose:
The core of this 510(k) submission is to demonstrate substantial equivalence to a previously legally marketed device (the Stratus® troponin I calibrator). This means the manufacturer presented evidence that the TROP CalPak is as safe and effective as the predicate device for its intended use. The "study" mentioned here is an internal demonstration of equivalence and conformity to manufacturing standards, rather than a clinical trial with patient outcomes.
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1981100
APR 16 1998
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 TROP CalPak
Summary of Safety and Effectiveness
The Stratus® CS TROP CalPak is an in vitro diagnostic product used to calibrate the cardiac troponin I method on the Stratus® CS STAT fluorometric analyzer.
The TROP CalPak is a buffered bovine protein matrix product with cardiac troponin I at an approximate concentration of 45 ng/mL. The CalPak is a plastic cartridge which contains the calibrator material in reagent wells.
The TROP CalPak is substantially equivalent to the Stratus® troponin I calibrator as they are both intended to be used as calibrators for similar cardiac troponin I methods.
Carolyn K. George
Carolyn K. George Regulatory Affairs and Compliance Manager
March 24, 1998
Date
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR | 6 1998
Carolyn K. George . Requlatory Affairs and Compliance Manager Dade Behring Inc. P.O. Box 6101 Newark, Delaware 19714
K981100 Re : Stratus® CS TROP CalPak Regulatory Class: II Product Code: JIT Dated: March 24, 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 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 (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. ಗಿ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq 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 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 (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 Sitman
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: Dade Behring TROP CalPak
Indications for Use: The TROP CalPak is an in vitro diagnostic product used to calibrate the cardiac troponin I method on the Stratus® CS STAT fluorometric analyzer. This calibrator is a device intended to establish a point of reference that is used in the determination of troponin I values.
Carolyn K. George
Carolyn K. George Regulatory Affairs and Compliance Manager
March 24, 1998
Date
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
K981/100
510(k) Number
Division Sign-Off, Office of Device Evaluation
prescription use
Division Sign Off
(Division Sign-Off)
DivicLaboratory,
510(k) Number
K981100
0000006
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.