(90 days)
Dade Behring Stratus CS Cardiac Troponin I TestPak
Not Found
No
The summary describes a standard in vitro diagnostic test using electrochemical sensing and automated fluid handling. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
This device is an in vitro diagnostic test used to measure cardiac troponin I, aiding in diagnosis and risk stratification, but it does not directly treat or provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the i-STAT cTnl test is "an in vitro diagnostic test for the quantitative measurement of cardiac troponin I... used as an aid in the diagnosis and treatment of myocardial infarction."
No
The device is an in vitro diagnostic test that utilizes a physical cartridge and an analyzer (i-STAT 1 Analyzer) to perform the analysis of a blood sample. This involves hardware components and physical processes, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that 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."
- Sample Type: The device analyzes biological samples (whole blood or plasma) taken from the human body.
- Purpose: The test is used to provide information that aids in the diagnosis and treatment of a medical condition (myocardial infarction and acute coronary syndromes).
- Device Description: The description details how the device processes the sample and performs the analysis outside of the body.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MMI
Device Description
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.
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
trained health care professionals
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Performance in Support of Substantial Equivalence:
- Studies established that the i-STAT cTnl test is insensitive to hematocrit levels from 0 to 65 . %PCV.
- . Studies established that isoforms of cTnl were detected to similar extents by the i-STAT and Stratus CS methods. When free cTnl. IC complex, ITC complex, dephosphorated, and phosphorated isoforms were tested, the relative responses for the two methods ranged from 83% to 122%.
- . 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 the Stratus CS cardiac troponin I test.
- . Studies established that the lower limit of detection (LLD) for the i-STAT method is a comparable 0.02 ng/mL versus 0.03ng/mL for the Stratus CS method.
- . The imprecision of the i-STAT cTnl test using plasma controls was established using inhouse and user studies. The Level 1 Control %CV was 7.8% at 0.53 ng/mL. the Level 2 Control %CV was 8.5% at 2.17 ng/mL, and the Level 3 Control %CV was 7.6% at 31.82 ng/mL. This includes within-lot, lot-to-lot, vial-to-vial, analyzer-to-analyzer, and operator-tooperator components of the imprecision.
Summary of Clinical Test Performance in Support of Substantial Equivalence Claims:
Studies conducted at three external clinical sites compared the results of the i-STAT cTnl test to those of the Dade Behring Stratus CS STAT Fluorometric Analyzer using the Stratus CS Cardiac Troponin I TestPak for samples from patients who presented to the hospital with acute, severe, and prolonged chest pain. Heparinized whole blood and plasma samples were analyzed on the i-STAT System while plasma samples were analyzed on the Stratus CS. The methods were compared using Deming regression analysis.
Results for i-STAT whole blood vs. Stratus CS plasma:
- all samples: N=189, Mean=4.79, Range=0-46.27, Sxx=0.28, Syy=0.31, Slope=0.883, Intercept=0.029, Correlation=0.975, Sy.x=1.40
- samples where [cTnl]
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for i-STAT Corporation. The logo consists of the text "i-STAT" in a large, bold, sans-serif font. The "i" is lowercase, and there is a hyphen between the "i" and "STAT". Below the main text, in a smaller font, is the word "CORPORATION" in all caps. A thin line is present above the "i-STAT" text.
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: June 3, 2003
Submitted by:
i-STAT Corporation 104 Windsor Center Drive E. Windsor, NJ 08520 Phone: 609-443-9300 FAX: 609-443-9310
Contact:
Gregory W. Shipp, MD Vice-President, Medical Affairs i-STAT Corporation 104 Windsor Center Drive East Windsor, NJ 08520 Phone: 609-443-9300 Fax: 609-443-9310
Establishment Registration Number: 2245578
Identification of Device:
Device Name: Cardiac Troponin 1 (cTnl) Test Proprietary/Trade Name: i-STAT® cTnl Test Common Name: cardiac troponin I, cTnl Device Classification: II Regulation Number: CFR§ 862.1215 Panel: Immunoassay Method, Troponin Subunit Product Code: MMI
Identification of the Predicate Device:
Device Name: Dade Behring Stratus CS Cardiac Troponin I TestPak
Intended Use of the Device:
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.
Description of the Device:
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.
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 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.
Comparison to Technological Features of the Predicate Device:
The following is a comparison of technological features of the i-STAT and Stratus CS Cardiac Troponin I methods:
| Characteristic | Stratus CS | i-STAT System |
|---|---|---|
| Assay methodology | Two site ELISA | Two site ELISA |
| Capture site | Heterogeneous | Heterogeneous |
| Capture antibodies | Monoclonal | Monoclonal |
| Enzyme label antibody | Monoclonal | Polyclonal |
| Enzyme label | Alkaline phosphatase | Alkaline phosphatase |
| Analysis sequence | Sequential capture/label | Simultaneous capture/label |
| Analysis time | 14 minutes | 10 minutes |
| Sample type | 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 cTnl test is insensitive to hematocrit levels from 0 to 65 . %PCV.
- . Studies established that isoforms of cTnl were detected to similar extents by the i-STAT and Stratus CS methods. When free cTnl. IC complex, ITC complex, dephosphorated, and phosphorated isoforms were tested, the relative responses for the two methods ranged from 83% to 122%.
- . 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 the Stratus CS cardiac troponin I test.
- . Studies established that the lower limit of detection (LLD) for the i-STAT method is a comparable 0.02 ng/mL versus 0.03ng/mL for the Stratus CS method.
- . The imprecision of the i-STAT cTnl test using plasma controls was established using inhouse and user studies. The Level 1 Control %CV was 7.8% at 0.53 ng/mL. the Level 2 Control %CV was 8.5% at 2.17 ng/mL, and the Level 3 Control %CV was 7.6% at 31.82 ng/mL. This includes within-lot, lot-to-lot, vial-to-vial, analyzer-to-analyzer, and operator-tooperator components of the imprecision.
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Summary of Clinical Test Performance is Support of Substantial Equivalence Claims: Studies conducted at three external clinical sites compared the results of the i-STAT cTnl test to those of the Dade Behring Stratus CS STAT Fluorometric Analyzer using the Stratus CS Cardiac Troponin I TestPak for samples from patients who presented to the hospital with acute, severe, and prolonged chest pain. Heparinized whole blood and plasma samples were analyzed on the i-STAT System while plasma samples were analyzed on the Stratus CS. The methods were compared using Deming regression analysis. The results are summarized in the table below:
| | | i-STAT whole blood vs
Stratus CS plasma | | i-STAT plasma vs
i-STAT whole blood | |
|-------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|-------------------------------------------|----------------------------------------|-------------------------------------------|
| Statistic | Definition | all
samples | samples
where
[cTnl] Trade/Device Name: i-STAT® cTnI Test Regulation Number: 21 CFR § 862.1215 Regulation Name: Immunoassay Method, Troponin Subunit Regulatory Class: II Product Code: MMI Dated: June 3, 2003 Received: June 4, 2003
Dear Dr. Shipp:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for use 3
510(k) Number (if known): K03 1739
Device Name: i-STAT Cardiac Troponin I test
The i-STAT Cardiac Troponin I (cTnl) test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109)
Sean Cooper
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K031739
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prescription
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