(113 days)
Not Found
No
The device description details a standard immunoassay technology (LOCI™) for measuring cardiac troponin I. There is no mention of AI, ML, or any computational algorithms beyond basic signal processing for quantitative measurement. The performance studies focus on analytical and clinical performance metrics typical of an immunoassay, not on the performance of an AI/ML model.
No
The device is an in vitro diagnostic test used for the quantitative measurement of cardiac troponin I to aid in the diagnosis of acute myocardial infarction, not to treat a condition.
Yes
The intended use states that the device is an "in vitro diagnostic test for the quantitative measurement of cardiac troponin I in human serum" and that these measurements are "used to aid in the diagnosis of acute myocardial infarction (AMI) and in the risk stratification of patients with acute coronary syndromes."
No
The device description clearly outlines physical components including reagents (latex beads, antibodies), calibrators (frozen liquid product), and sample diluent (liquid product). It also describes a chemiluminescent immunoassay process involving chemical reactions and light measurement, which are hardware-dependent functions performed on the Dimension Vista™ System. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states that the CTNI method and CTNI CAL are "in vitro diagnostic tests" and "in vitro diagnostic products" respectively. Their intended use is for the quantitative measurement of cardiac troponin I in human serum to aid in the diagnosis of acute myocardial infarction (AMI) and risk stratification of patients with acute coronary syndromes. This clearly falls under the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of disease.
- Device Description: The description details a laboratory-based immunoassay method (LOCI™ technology) that analyzes a human sample (serum) to measure a specific analyte (cardiac troponin I). This is characteristic of an in vitro diagnostic test.
- Calibration and Diluent: The inclusion of a calibrator (CTNI CAL) and a sample diluent (CTNI SDIL) further supports its use as a diagnostic test performed in a laboratory setting.
- Performance Studies and Key Metrics: The document provides details on method comparison, reproducibility, analytical sensitivity, functional sensitivity, analytical specificity, interferences, and hook effect. These are all standard performance characteristics evaluated for in vitro diagnostic devices to demonstrate their accuracy and reliability.
- Predicate Device: The mention of a predicate device (Dade Behring Dimension® CTNI immunoassay and Calibrator) with K numbers (K010313/K010314) indicates that this device is being compared to a previously cleared IVD.
Based on the information provided, the device is clearly intended for and functions as an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Method:
The CTNI method is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in human serum on the Dimension Vista ™ System. Measurements of cardiac troponin I are used to aid in the diagnosis of acute myocardial infarction (AMI) and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
Calibrator:
The CTNI CAL is an in vitro diagnostic product for the calibration of cardiac Troponin-1 (CTNI) on the Dimension Vista™ system.
I)iluent:
For use on the Dimension Vista™ System to dilute samples with elevated CTNI results.
Product codes (comma separated list FDA assigned to the subject device)
MMI, JIT
Device Description
Method
The CTNI method is a one-step sandwich chemiluminescent immunoassay based on Luminescent Oxygen Channeling Immunoassay (LOCI™) technology. LOCI™ reagents include two latex bead reagents and a biotinylated anti-cardiac troponin I monoclonal antibody fragment. The first bead reagent (Sensibeads) is coated with streptavidin and contains photosensitive dye. The second bead reagent (Chemibeads) is coated with a second anti-cardiac troponin I monoclonal antibody and contains chemiluminescent dye. Sample is incubated with Chemibeads and biotinylated antibody to form a particle/cardiac troponin I/biotinylated antibody sandwich. Sensibeads then are added and bind to the biotin to form beadaggregated immunocomplexes. Illumination of the complex by light at 680 nm generates singlet oxygen from Sensibeads, which diffuses into the Chemibeads and triggers a chemiluminescent reaction. The resulting chemiluminescent signal is measured at 612 nm and is a direct function of the cardiac troponin I concentration in the sample.
Calibrator
The Dade Behring CTNI Calibrator is a three level frozen liquid product (levels A, B, C) containing human troponin complex in a human serum matrix with stabilizers and preservative. The kit contains 3 vials of each level (A= 2.0 mL, B= 1.0 mL, C= 1.5 mL).
Sample Diluent
The Dimension Vista™ CTNI SDIL Sample Diluent is a single level liquid product containing a human serum matrix with stabilizers and preservative. The kit contains 6 vials with 2.5 mL in each vial.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical Results
Method Comparison
A split sample method comparison demonstrated good agreement between the Dade Behring Dimension Vista™ CTNI method and the predicate Dade Behring Dimension® CTNI immunoassay with serum patient samples.
Slope: 1.015
Intercept (ng/mL): -0.003
Correlation Coefficient: 0.993
n: 197
The model equation for the linear least squares regression statistics is: [results for Dimension Vista™ CTNI] = slope x [comparative method results] + intercept. The range of CTNI values in the correlation study was: 0 to 35.72 ng/mL.
Reproducibility
Typical precision observed for the Dimension Vista™ CTNI method is summarized below:
Serum Pool, Level 1: Mean (ng/mL) 0.123, Repeatability SD (ng/mL) 0.005, Repeatability %CV 4.21, Within Lab SD (ng/mL) 0.007, Within Lab %CV 5.77
Serum Pool, Level 2: Mean (ng/mL) 0.55, Repeatability SD (ng/mL) 0.012, Repeatability %CV 2.28, Within Lab SD (ng/mL) 0.016, Within Lab %CV 2.93
Serum Pool, Level 3: Mean (ng/mL) 24.51, Repeatability SD (ng/mL) 1.012, Repeatability %CV 4.13, Within Lab SD (ng/mL) 1.167, Within Lab %CV 4.60
Serum Pool, Level 32: Mean (ng/mL) 31.41, Repeatability SD (ng/mL) 0.95, Repeatability %CV 3.0, Within Lab SD (ng/mL) 1.18, Within Lab %CV 3.76
The reproducibility testing was conducted in accordance with the CLSI/NCCLS Approved Guideline for User Evaluation of Precision Performance of Clinical Chemistry Devices EP5-A2. For each test level, a single test from two independent cups was analyzed twice per day. The within-run and total standard deviations were calculated by the analysis of variance method.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Method
Reportable Range: 0.015 to 40 ng/mL
Analytical Sensitivity: 0.015 ng/mL
Functional Sensitivity: 0.04 ng/mL
Analytical Specificity (Cross reactivity at 1000 ng/mL):
skeletal muscle troponin-I: 0.12 ng/mL
cardiac troponin -T: 0.06 ng/mL
cardiac troponin-C: 0 ng/mL
Interferences: No significant interference from: bilirubin, conjugated up to 40 mg/dL, bilirubin, unconjugated up to 40 mg/dL, hemoglobin up to 500 mg/dL and triglycerides up to 3000 mg/dL.
Hook Effect: No high dose effect up to 1000 ng/mL
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
APR 1 4 2006
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Submitter's Name: | George M. Plummer
Dade Behring Inc.
P.O. Box 6101
Newark, DE 19714-6101 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Date of Preparation: | December 20, 2005 |
| Name of Product(s): | Dimension Vista™ CTNI Flex® reagent cartridge
Dimension Vista™ CTNI Calibrator
Dimension Vista™ CTNI SDIL Sample Diluent |
| FDA Classification Name(s): | Immunoassay method, Troponin subunit (862.1215), secondary
calibrator (862.1150) both Class II |
| FDA Guidance Documents: | None applicable |
| Predicate Device(s): | Dade Behring CTNI immunoassay and Calibrator
(K010313/K010314) |
Device Description(s):
Method
The CTNI method is a one-step sandwich chemiluminescent immunoassay based on Luminescent Oxygen Channeling Immunoassay (LOCI™) technology. LOCI™ reagents include two latex bead reagents and a biotinylated anti-cardiac troponin I monoclonal antibody fragment. The first bead reagent (Sensibeads) is coated with streptavidin and contains photosensitive dye. The second bead reagent (Chemibeads) is coated with a second anti-cardiac troponin I monoclonal antibody and contains chemiluminescent dye. Sample is incubated with Chemibeads and biotinylated antibody to form a particle/cardiac troponin I/biotinylated antibody sandwich. Sensibeads then are added and bind to the biotin to form beadaggregated immunocomplexes. Illumination of the complex by light at 680 nm generates singlet oxygen from Sensibeads, which diffuses into the Chemibeads and triggers a chemiluminescent reaction. The resulting chemiluminescent signal is measured at 612 nm and is a direct function of the cardiac troponin I concentration in the sample.
Calibrator
The Dade Behring CTNI Calibrator is a three level frozen liquid product (levels A, B, C) containing human troponin complex in a human serum matrix with stabilizers and preservative. The kit contains 3 vials of each level (A= 2.0 mL, B= 1.0 mL, C= 1.5 mL).
Sample Diluent
The Dimension Vista™ CTNI SDIL Sample Diluent is a single level liquid product containing a human serum matrix with stabilizers and preservative. The kit contains 6 vials with 2.5 mL in each vial.
1
Intended Use:
Method
The CTNI method is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in human serum on the Dimension Vista™ System. Measurements of cardiac troponin I are used to aid in the diagnosis of acute myocardial infarction (AMI) and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
Calibrator:
The CTNI CAL is an in vitro diagnostic product for the calibration of cardiac Troponin-I (CTNI) on the Dimension Vista™ system.
Diluent:
For use on the Dimension Vista™ System to dilute samples with elevated CTNI results.
Substantial Equivalence
Method
A summary of the features of the Dade Behring Dimension Vista™ CTNI Flex® reagent cartridge and the predicate Dade Behring Dimension® CTNI reagent cartridge immunoassay (K010313/K010314) is provided in the following charts.
| Feature | Dimension® CTNI | Dimension Vista™ CTNI |
|---|---|---|
| Intended Use | For the in vitro quantitative | |
| determination of cardiac troponin | ||
| -I in human serum and | ||
| heparinized plasma as an aid in | ||
| the diagnosis of myocardial | ||
| infarction and in the risk | ||
| stratification of patients with | ||
| acute coronary syndromes with | ||
| respect to their relative risk of | ||
| mortality. | The CTNI method is an in vitro | |
| diagnostic test for the quantitative | ||
| measurement of cardiac troponin I in | ||
| human serum on the Dimension Vista™ | ||
| System. Measurements of cardiac | ||
| troponin I are used to aid in the | ||
| diagnosis of acute myocardial infarction | ||
| (AMI) and in the risk stratification of | ||
| patients with acute coronary syndromes | ||
| with respect to their relative risk of | ||
| mortality. | ||
| Assay Type | photometric immunoassay | chemiluminescent immunoassay |
| Reportable Range | 0.04 to 40 ng/mL | 0.015 to 40 ng/mL |
| Antibody | Dade Behring mouse monoclonal | Dade Behring mouse monoclonal |
| Analytical | ||
| Sensitivity | 0.04 ng/mL | 0.015 ng/mL |
Method:
2
| Functional
| Sensitivity | Not specified | 0.04 ng/mL |
|---|---|---|
| Analytical | ||
| Specificity | Cross reactivity at 1000 ng/mL | |
| with skeletal muscle troponin-I, | ||
| cardiac troponin -T and cardiac | ||
| troponin-C is 0.04 ng/mL, 0.34 | ||
| ng/mL and 0 ng/mL | ||
| respectively. | Cross reactivity at 1000 ng/mL with | |
| skeletal muscle troponin-I, cardiac | ||
| troponin -T and cardiac troponin-C is | ||
| 0.12 ng/mL, 0.06 ng/mL and 0 ng/mL | ||
| respectively. | ||
| Interferences | No significant interference from: | |
| bilirubin up to 20 mg/dL, | ||
| hemoglobin up to 1000 mg/dL | ||
| and triglycerides up to 3000 | ||
| mg/dL | No significant interference from: | |
| bilirubin, conjugated up to 40 mg/dL | ||
| bilirubin, unconjugated up to 40 mg/dL, | ||
| hemoglobin up to 500 mg/dL and | ||
| triglycerides up to 3000 mg/dL. | ||
| Hook Effect | No high dose effect up to 1800 | |
| ng/mL | No high dose effect up to 1000 ng/mL | |
| Calibration Interval | Calibration curve updated for | |
| each lot, using five levels and | ||
| every 60 days, thereafter with | ||
| the same reagent lot. | Calibration curve updated for each lot, | |
| using six levels every 30 days with the | ||
| same reagent lot. | ||
| Sample Volume | 50 uL | 20 uL |
Calibrator:
| Feature | Dimension® CTNI | Dimension Vista™ CTNI |
|---|---|---|
| Intended Use | CTNI method calibration | CTNI method calibration |
| Analyte | Human troponin complex | Human troponin complex |
| Matrix | Human serum | Human serum |
| Form | Liquid, frozen | Liquid, frozen |
| Volume | 10 vials, 2 at each level, 2 mL each | 6 vials, 2 at each level, Level A = 2.0 mL |
| Level B = 1.0 mL and Level C = 1.5 mL | ||
| Levels | 5 levels (0, 2, 10, 25, and 45 ng/mL) | 3 levels provided (0, 0.5 and 41 ng/mL); |
| three additional levels made on-board |
Method performance Summary:
Analytical Results
Method Comparison
A split sample method comparison demonstrated good agreement between the Dade Behring Dimension Vista™ CTNI method and the predicate Dade Behring Dimension® CTNI immunoassay with serum patient samples.
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| Comparative | Intercept | Correlation | ||
|---|---|---|---|---|
| Method | Slope | (ng/mL) | Coefficient | n |
| Dimension® CTNI | 1.015 | -0.003 | 0.993 | 197 |
The model equation for the linear least squares regression statistics is: [results for Dimension Vista™ CTNI] = slope x [comparative method results] + intercept. The range of CTNI values in the correlation study was: 0 to 35.72 ng/mL.
Reproducibility
Typical precision observed for the Dimension Vista™ CTNI method is summarized below:
| Repeatability | Within Lab | ||||
|---|---|---|---|---|---|
| Sample | Mean (ng/mL) | SD (ng/mL) | %CV | SD (ng/mL) | %CV |
| Serum | |||||
| Pool, | |||||
| Level 1 | 0.123 | 0.005 | 4.21 | 0.007 | 5.77 |
| Serum | |||||
| Pool, | |||||
| Level 2 | 0.55 | 0.012 | 2.28 | 0.016 | 2.93 |
| Serum | |||||
| Pool, | |||||
| Level 3 | 24.51 | 1.012 | 4.13 | 1.167 | 4.60 |
| Serum | |||||
| Pool, | |||||
| Level 32 | 31.41 | 0.95 | 3.0 | 1.18 | 3.76 |
The reproducibility testing was conducted in accordance with the CLSI/NCCLS Approved Guideline for User Evaluation of Precision Performance of Clinical Chemistry Devices EP5-A2. For each test level, a single test from two independent cups was analyzed twice per day. The within-run and total standard deviations were calculated by the analysis of variance method.
4
Calibrator
The Dimension Vista™ CTNI Calibrator is similar to other calibrator products associated with their assays, such as the Dimension® CTNI Calibrator.
Sample Diluent
The Dimension Vista™ CTNI SDIL Sample Diluent is similar to other diluent products associated with their assays.
Comments on Substantial Equivalence:
Both the Dimension Vista™ CTNI reagent cartridge and the Dimension® CTNI immunoassays are intended for the quantitative determination of troponin I. Comparative data for human serum samples demonstrate good analytical and clinical agreement between the methods.
Conclusion:
The Dade Behring Dimension Vista™ CTNI and the predicate Dade Behring Dimension® CTNI immunoassays (K010313/K010314) are substantially equivalent based on their intended use and performance characteristics as described above. The calibrator products are also equivalent in their design and intended use with their respective assay systems.
George M. Plummer Regulatory Affairs and Compliance Manager December 20, 2005
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with text around the perimeter. The text is small and difficult to read, but it appears to be the name of the department.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 1 4 2006
Mr. George M. Plummer Regulatory Affairs and Compliance Manager Dade Behring Inc. Glasgow Business Community Bldg. 500 Mail Box 514 PO Box 6101 Newark, DE 19714-6101
K053577 Re:
Trade/Device Name: Dimension Vista™ CTNI Flex® reagent cartridge Dimension Vista™ CTNI Calibrator Dimension Vista™ CTNI SDIL Sample Diluent Regulation Number: 21 CFR$862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: MMI and JIT Dated: February 24, 2006 Received: February 27, 2006
Dear Mr. Plummer:
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 adultcration.
If your device is classified (see above) into cither 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 (QS) regulation (21 CFR Part 820).
6
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.
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 (240) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Alberto Gatti
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
INDICATIONS FOR USE STATEMENT
510(k) Number (If Known):
Device(s) Name(s):
Dimension Vista™ CTNI Flex® reagent cartridge Dimension Vista™ CTNI Calibrator Dimension Vista™ CTNI SDIL Sample Diluent
Indications for Use:
Method:
The CTNI method is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in human serum on the Dimension Vista ™ System. Measurements of cardiac troponin I are used to aid in the diagnosis of acute myocardial infarction (AMI) and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
Calibrator:
The CTNI CAL is an in vitro diagnostic product for the calibration of cardiac Troponin-1 (CTNI) on the Dimension Vista™ system.
I)iluent:
For use on the Dimension Vista™ System to dilute samples with elevated CTNI results.
Prescription Use X (Part 21 CFR 801 Subpart D) and/or
Over-the-counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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