(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.
§ 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.