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510(k) Data Aggregation
(197 days)
I-STAT CREATINE KINASE MB (CK-MB)
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: 0.994
**Samples where [CK-MB]
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