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510(k) Data Aggregation
(197 days)
The i-STAT CK-MB test is an in vitro diagnostic test for the quantitative measurement of creatine kinase MB in whole blood or plasma samples. CK-MB measurements can be used as an aid in the diagnosis of myocardial infarction (MI).
The cartridge is to be used with the i-STAT 1 Analyzer bearing the (Immuno) symbol, 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 CK-MB test is to be used by trained health care professionals in accordance with a facility's policies and procedures.
The i-STAT Cardiac Troponin I (cTnl) test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in whole blood or plasma. Measurements on cardiac troponin I are used as an aid in the diagnosis and treatment of patients with acute 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 i-STAT CK-MB test is contained in a single-use test cartridge. In use, the user scans a bar code and then places approximately 16 uL of whole blood or plasma in the cartridge. After the cartridge is closed, it is inserted into the thermally controlled i-STAT 1 Analyzer, and all analytical steps are performed automatically. Patient and use 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 substratelwash 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 CK-MB sensor cleaves the substrate present in the substrate/wash fluid, giving rise to an amperometric signal which is measured.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the i-STAT CK-MB Test.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for substantial equivalence are not explicitly stated as numerical targets in the document. Instead, the general criteria are that the device should be "substantially equivalent" to the predicate device in terms of performance and safety. The reported device performance is compared to the predicate and to laboratory standards.
| Acceptance Criteria (Implied) | Reported Device Performance (i-STAT CK-MB Test) |
|---|---|
| Insensitivity to various hematocrit levels | Insensitive to hematocrit levels from 0 to 70 %PCV. |
| Not significantly influenced by other CK isoforms | Not significantly influenced by the presence of CK-BB at 100 ng/mL or CK-MM at 10,000 ng/mL. |
| Similar interference effects from common medications to predicate | Interference effects from common medications (especially those for cardiovascular conditions) were similar to the Triage Cardiac Panel CK-MB. |
| Acceptable Lower Limit of Detection (LLD) | LLD of 0.6 ng/mL (comparable to predicate's 1.0 ng/mL). |
| Adequate imprecision for various control levels | Level 1 control %CV: 11.9% at 5.9 ng/mL Level 2 control %CV: 10.4% at 25.8 ng/mL Level 3 control %CV: 10.0% at 90.1 ng/mL |
| Acceptable clinical correlation to predicate device (Abbott AxSYM) | All Samples (N=263):- Slope: 1.01- Intercept: -0.19- Correlation: 0.994Samples where [CK-MB] < 20.0 ng/mL (N=234):- Slope: 0.993- Intercept: -0.05- Correlation: 0.960 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 263 patient samples for the overall comparison, and 234 samples for the subset where CK-MB < 20.0 ng/mL.
- Data Provenance: The study states "Studies conducted at clinical sites," suggesting a prospective collection for the purpose of the study. The origin (country/specific sites) is not explicitly mentioned, but it's likely U.S. clinical sites given the FDA submission. The data is described as "samples from patients who presented to the hospital with chest pain," indicating clinical relevance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For in vitro diagnostic devices like the i-STAT CK-MB test, "ground truth" is typically established by comparing the device's results to a recognized reference method (the predicate device, in this case, the Abbott AxSYM). No human expert interpretation of images or data, as might be seen in diagnostic imaging, is involved in establishing the "ground truth" for quantitative biochemical measurements.
4. Adjudication Method for the Test Set
This term is generally not applicable to the type of quantitative in vitro diagnostic study described. Adjudication methods (like 2+1, 3+1) are primarily used in studies involving human interpretation (e.g., radiology reads) to resolve discrepancies among experts. In this study, the comparison is directly between quantitative measurements from two different analytical devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study involves multiple human readers interpreting cases, often with and without AI assistance, to measure the impact of the AI on human performance. The current study focuses on the standalone performance of the i-STAT CK-MB device compared to a predicate device.
6. If a Standalone Study Was Done
Yes, a standalone study was done. The entire clinical and non-clinical performance summary describes the i-STAT CK-MB test's performance without human intervention in the analytical process. The i-STAT 1 Analyzer performs "all analytical steps... automatically" after the sample is inserted. Its results are then compared to the predicate device.
7. The Type of Ground Truth Used
The ground truth for the clinical comparison was the results obtained from the Abbott AxSYM CK-MB test. The document states, "Clinical sites compared the results of the i-STAT CK-MB test to those of the CK-MB test on the Triage Cardiac Panel for samples from patients who presented to the hospital with chest pain. Heparinized whole blood and plasma samples were analyzed on the i-STAT System while plasma samples were analyzed on the Abbott AxSYM." This indicates the Abbott AxSYM served as the comparative or reference method.
8. The Sample Size for the Training Set
The document does not specify a separate training set size. The studies described are for validation/testing of the device's performance. For diagnostic tests like this, the "training" (development) of the assay is an internal process by the manufacturer, but the specific volume of samples used for that internal development is not typically disclosed in a 510(k) summary focused on validation.
9. How the Ground Truth for the Training Set Was Established
Since no distinct "training set" with established ground truth is mentioned for the purpose of this submission, this information is not provided. The development of an immunoassay typically involves extensive internal R&D, calibration, and optimization using characterized materials and reference methods, but these details are not part of the 510(k) summary's scope.
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