(197 days)
"Triage Cardiac Panel"
There are no reference devices mentioned in the provided text.
No
The description focuses on the automated analytical steps and electrochemical detection method, with no mention of AI or ML.
No.
The device is an in vitro diagnostic test used to aid in the diagnosis of myocardial infarction, not to provide therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the i-STAT CK-MB test and i-STAT Cardiac Troponin I (cTnl) test are "in vitro diagnostic tests" and are used "as an aid in the diagnosis of myocardial infarction (MI)" and "as an aid in the diagnosis and treatment of patients with acute myocardial infarction."
No
The device description clearly details a physical test cartridge and an analyzer that performs automated analytical steps, including temperature control and fluid handling. This indicates a significant hardware component, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "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."
- "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."
This directly identifies the device as an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
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 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 of cardiac troponin I are used as an aid in the diagnosis and treatment of patients with acute myocardial infarction and as an aid in assessing their relative risk of mortality.
Product codes
MYT, MMI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-Clinical Performance:
- Studies established that the i-STAT CK-MB test is insensitive to hematocrit levels from 0 to 70 %PCV.
- The CK-MB assay is not significantly influenced by the presence of CK-BB at 100 ng/mL or CK-MM at 10,000 ng/mL.
- Studies established that the interference effects from common medications, particularly those commonly prescribed to patients with cardiovascular conditions, were similar to the effects for those drugs on CK-MB of the Triage Cardiac Panel.
- Studies established that the lower limit of detection (LLD) for the i-STAT method is a comparable 0.6 ng/mL versus 1.0 ng/mL for the CK-MB of the Triage Cardiac Panel.
- The imprecision of the i-STAT CK-MB test using plasma controls was established using inhouse and user studies. The Level 1 control %CV was 11.9% at 5.9 ng/mL, the Level 2 control %CV was 10.4% at 25.8 ng/mL and the Level 3 control %CV was 10.0% at 90.1 ng/mL.
Clinical Test Performance:
Study Type: Comparison study
Sample Size: 263 (all samples), 234 (samples where [CK-MB]
§ 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.
0
DEC 15 2005
K 051433
510(k) Summary
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1900 and CFR 807.92.
The assigned 510(k) number is:
Summary prepared on: Sep 10, 2005
Submitted by:
i-STAT Corporation 104 Windsor Center Drive E. Windsor, NJ 08520 FAX: 609-443-9310 Phone: 609-443-9300
Contact:
Mike Zelin Vice-President, R&D i-STAT Corporation 104 Windsor Center Drive East Windsor, NJ 08520 Fax: 609-443-9310 Phone: 609-443-9300
Establishment Registration Number: 2245578
ldentification of Device: .
Device Name: CK-MB Test Proprietary/Trade Name: i-STAT® CK-MB Test Common Name: CK-MB, Creatine Kinase MB Isoenzymes Device Classification: II Requlation Number: 21 CFR§ 862.1215 Panel: Biosensor, Immunoassay, Cpk Or Isoenzymes Product Code: MYT
Identification of the Predicate Device:
Device Name: CK-MB test, Triage Cardiac Panel for use on the Triage Meter.
Intended Use of the Device:
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.
Description of the Device:
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.
1
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.
Comparison to Technological Features of the Predicate Device:
The followig is a comparison of technological features of the i-STAT and Triage Cardiac Panel CK-MB methods:
| Characteristic | Triage CK-MB | i-STAT CK-MB |
|---|---|---|
| Assay methodology | Two-site ELISA | Two-site ELISA |
| Capture site | Heterogeneous | Heterogeneous |
| Capture antibodies | Monoclonal | Monoclonal |
| Enzyme label antibody | Polyclonal | Monoclonal |
| Enzyme label | Fluorescent dye | Alkaline phosphatase |
| Analysis sequence | Simultaneous capture/label | Simultaneous capture/label |
| Analysis time | 16 minutes | 5 minutes |
| Sample type | Whole blood or plasma | Whole blood or plasma |
| Enzyme detection | Fluorescent | Electrochemical |
Summary of Non-Clinical Performance in Support of Substantial Equivalence:
- Studies established that the i-STAT CK-MB test is insensitive to hematocrit levels from 0 to . 70 %PCV.
- . The CK-MB assay is not significantly influenced by the presence of CK-BB at 100 ng/mL or CK-MM at 10,000 ng/mL.
- Studies established that the interference effects from common medications, particularly those . commonly prescribed to patients with cardiovascular conditions, were similar to the effects for those drugs on CK-MB of the Triage Cardiac Panel.
- . Studies established that the lower limit of detection (LLD) for the i-STAT method is a comparable 0.6 ng/mL versus 1.0 ng/mL for the CK-MB of the Triage Cardiac Panel.
- . The imprecision of the i-STAT CK-MB test using plasma controls was established using inhouse and user studies. The Level 1 control %CV was 11.9% at 5.9 ng/mL, the Level 2 control %CV was 10.4% at 25.8 ng/mL and the Level 3 control %CV was 10.0% at 90.1 ng/mL. This includes within-lot, lot-to-lot, vial-to-vial, analyzer-to-analyzer and operator-tooperator components of the imprecision.
2
Summary of Clinical Test Performance is Support of Substantial Equivalence Claims: Studies conducted at 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. The methods were compared using Deming regression analysis. The results are summarized in the table below:
and the first the became of the comment of the status
் பட்டி மாவட்டத்தில் அமைந்து வருகிறது துடுப்பது திருவுகள் பல்கலை மாவட்டத்தில் ப
| | Definition | i-STAT whole blood
and plasma vs Abbott
AxSYM plasma | |
|-------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|---------------------------------------------|
| Statistic | | all
samples | samples
where [CK-
MB]