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510(k) Data Aggregation
(90 days)
I-STAT CARDIAC TROPONIN (CTNI) TEST
The i-STAT cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac troponin I measurements can be used as an aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
The cartridge is to be used with the i-STAT 1 Analyzer, but not with the i-STAT Portable Clinical Analyzer or the Philips Medical Systems (formerly Agilent Technologies) Blood Analysis Module (BAM). As part of the i-STAT System, the cTnl test is to be used by trained health care professionals in accordance with a facility's policies and procedures.
The i-STAT cTnl test is contained in a single test cartridge. In use, the user scans a barcode and then places approximately 16 microliters of fresh whole blood in the cartridge is inserted into the thermally controlled i-STAT 1 Analyzer, and all analytical steps are performed automatically. Patient and user information may be entered into the analyzer via a keypad during the automated analysis cycle.
As the analyzer performs several quality checks and controls the temperature of the sensors via resistive heating to the underside of the sensor chips, the substrate/wash fluid is released into a conduit within the cartridge and a metered volume of the sample over the sensor chips. The enzyme-linked antibody conjugate dissolves into the sample and the sample incubates for a controlled time. The sample is then pushed into a waste chamber and the substrate/wash solution is brought over the sensors. The alkaline phosphatase captured on the cTnl sensor cleaves the substrate present in the substrate/wash fluid, giving rise to an amperometric signal which is measured.
The cTnl test cartridge is assembled from plastic components that provide the conduits for fluid handling and house the sensor chips. The test is identified to the user through the name and color code on the cartridge label and by the analyzer through features integral to the cartridge.
Here's a breakdown of the acceptance criteria and study information for the i-STAT cTnI Test, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a numerical or pass/fail format for clinical performance as might be seen for a new device. Instead, it demonstrates "substantial equivalence" to a predicate device. The performance metrics presented are comparative.
| Characteristic | Acceptance Criteria (Implied by Predicate Comparison) | Reported Device Performance (i-STAT cTnI) |
|---|---|---|
| Non-Clinical Performance | ||
| Hematocrit Insensitivity | Similar to predicate (Dade Behring Stratus CS) | Range of 0-65% PCV |
| Isoform Detection | Similar relative responses as predicate | Relative responses range from 83% to 122% compared to predicate for various isoforms |
| Drug Interference | Similar effects as predicate | Similar effects to common medications (especially CV drugs) |
| Lower Limit of Detection (LLD) | Comparable to predicate (0.03 ng/mL) | 0.02 ng/mL |
| Imprecision (Plasma Controls) | Adequate for low, mid-range, and high results | Level 1: 7.8% CV at 0.53 ng/mL; Level 2: 8.5% CV at 2.17 ng/mL; Level 3: 7.6% CV at 31.82 ng/mL |
| Clinical Performance (Correlation to Predicate) | ||
| i-STAT whole blood vs. Stratus CS plasma | ||
| - All samples | Acceptable correlation (e.g., high correlation coefficient, slope near 1, intercept near 0) | N=189; Mean Stratus CS: 4.79; Range: 0-46.27; Slope: 0.883; Intercept: 0.029; Correlation: 0.975; Sy.x: 1.40 |
| - Samples where [cTnI] |
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