(90 days)
K0101313
Not Found
No
The description details a standard immunoassay technology (LOCI™) for measuring cardiac troponin I. There is no mention of AI, ML, or any computational algorithms beyond standard signal processing for quantitative measurement.
No.
The device is an in vitro diagnostic test used for measurement of cardiac troponin I to aid in the diagnosis of acute myocardial infarction and risk stratification, not for therapeutic intervention.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the CTNI method is an "in vitro diagnostic test" used "to aid in the diagnosis of acute myocardial infarction (AMI)".
No
The device description clearly outlines a physical immunoassay method involving reagents, beads, and a chemiluminescent reaction, indicating it is a hardware-based in vitro diagnostic test, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The CTNI method is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in human serum and plasma..."
This statement directly identifies the device as an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The CTNI method is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in human serum and plasma 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.
Product codes
MMI
Device Description
The CTNI method is a one-step sandwich chemiluminescent immunoassay based on LOCI™ technology. LOCI™ reagents include two synthetic 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 bead-aggregated 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.
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
Not Found
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)
Method Comparison: A split, serum patient sample method comparison demonstrated good agreement between the revised Dade Behring Dimension Vista™ CTNI method and the predicate Dade Behring Dimension® CTNI method. Sample Range (Dimension®): 0-35.34, Sample Range (Dimension Vista®): 0.13 - 38.85, n=91, Slope=0.99, Intercept=-0.10, Correlation Coefficient=0.993. The model equation for the linear least squares regression statistics is: [results for revised Dimension Vista™ CTNI] = slope x [comparative method results] + intercept.
Serum versus Plasma Results: Comparison of sixty-three matched serum and lithium heparin plasma samples were tested with the revised Dimension Vista™ CTNI method. Plasma Sample Range: 0.026-23.7, Serum Sample Range: 0.026-22.9, n=63, Slope=1.02, Intercept=0.031, Correlation Coefficient=0.999.
Lithium Heparin versus Sodium Heparin Results: Comparison of 50 matched lithium and sodium heparin plasma samples were tested with the revised Dimension Vista™ CTNI method. Li Heparin Sample Range: 0.09 - 39.85, Na Heparin Sample Range: 0.1 - 38.2, n=50, Slope=0.99, Intercept=-0.05, Correlation Coefficient=0.998.
Reproducibility: Typical precision observed for the Dimension Vista™ CTNI method is summarized below, conducted in accordance with the CLSI Approved Guideline for User Evaluation of Precision Performance of Clinical Chemistry Devices EPS-A2. For each test level, a single test from two independent cups was analyzed twice per day. The repeatability and within-lab standard deviations were calculated by the analysis of variance method.
Serum Pool 1: Mean (ng/mL) 0.073, Repeatability SD (ng/mL) 0.003, Repeatability %CV 3.8, Within Lab SD (ng/mL) 0.005, Within Lab %CV 7.36
Serum Pool 2: Mean (ng/mL) 0.43, Repeatability SD (ng/mL) 0.005, Repeatability %CV 1.25, Within Lab SD (ng/mL) 0.014, Within Lab %CV 3.18
Serum Pool 3: Mean (ng/mL) 22.5, Repeatability SD (ng/mL) 0.237, Repeatability %CV 1.05, Within Lab SD (ng/mL) 0.499, Within Lab %CV 2.22
Serum Pool 4: Mean (ng/mL) 30.55, Repeatability SD (ng/mL) 0.310, Repeatability %CV 1.0, Within Lab SD (ng/mL) 0.975, Within Lab %CV 3.76
Biorad Cardiac Quality Control, Level 2: Mean (ng/mL) 0.51, Repeatability SD (ng/mL) 0.009, Repeatability %CV 1.7, Within Lab SD (ng/mL) 0.005, Within Lab %CV 1.05
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Analytical Sensitivity: 0.015 ng/mL
Functional Sensitivity: 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 0.14 ng/mL, 0.05 ng/mL and 0 ng/mL respectively.
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.
K0101313
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
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 | MAR 1 9 200 |
|-----------------------------|----------------------------------------------------------------------------------|-------------|
| Date of Preparation: | December 18, 2006 | |
| Name of Product(s): | Dimension Vista™ CTNI Flex® reagent cartridge | |
| FDA Classification Name(s): | Immunoassay method, Troponin subunit (862.1215) | |
| FDA Guidance Documents: | None applicable | |
| Predicate Device(s): | Dade Behring Dimension® CTNI immunoassay (K0101313) | |
Device Description(s):
The CTNI method is a one-step sandwich chemiluminescent immunoassay based on LOCI™ technology. LOCI™ reagents include two synthetic 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 bead-aggregated 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.
Intended Use:
The CTNI method is an in vitro diagnostic test for the quantitative measurement of cardiac troponin 1 in human serum and plasma 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.
Substantial Equivalence
A summary of the performance attributes of the Dade Behring Dimension Vista™ CTNI Flex® reagent cartridge and the predicate Dade Behring Dimension® CTNI reagent cartridge immunoassay (K0101313) is provided in the following chart.
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| Feature | Dimension® CTNI | Revised 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. | For the in vitro quantitative | |
| determination of cardiac troponin -I in | ||
| human serum and heparinized plasma | ||
| as an aid in the diagnosis of myocardia | ||
| infarction and in the risk stratification | ||
| of patients with acute coronary | ||
| syndromes with respect to their relativ | ||
| 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 |
| 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 | ||
| 0.14 ng/mL, 0.05 ng/mL and 0 ng/mL | ||
| respectively. | ||
| 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 µL | 20 µL |
and the comments of the comments of
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Method performance Summary:
Analytical Results
Method Comparison
A split, serum patient sample method comparison demonstrated good agreement between the revised Dade Behring Dimension Vista™ CTNI method and the predicate Dade Behring Dimension® CTNI method.
| Dimension®
Sample
Range | Dimension
Vista® Sample
Range | n | Slope | Intercept | Correlation
Coefficient |
|-------------------------------|-------------------------------------|----|-------|-----------|----------------------------|
| 0-35.34 | 0.13 - 38.85 | 91 | 0.99 | -0.10 | 0.993 |
The model equation for the linear least squares regression statistics is: [results for revised Dimension Vista™ CTNI] = slope x [comparative method results] + intercept.
Serum versus Plasma Results
Comparison of sixty-three matched serum and lithium heparin plasma samples were tested with the revised Dimension Vista™ CTNI method. The following table summarizes the linear least squares regression from the study.
| Plasma Sample
Range | Serum Sample
Range | n | Slope | Intercept | Correlation
Coefficient |
|------------------------|-----------------------|----|-------|-----------|----------------------------|
| 0.026-23.7 | 0.026-22.9 | 63 | 1.02 | 0.031 | 0.999 |
Lithium Heparin versus Sodium Heparin Results
Comparison of 50 matched lithium and sodium heparin plasma samples were tested with the revised Dimension Vista™ CTNI method. The following table summarizes the linear least squares regression results from the study.
| Li Heparin
Sample Range | Na Heparin
Sample Range | n | Slope | Intercept | Correlation
Coefficient |
|----------------------------|----------------------------|----|-------|-----------|----------------------------|
| 0.09 - 39.85 | 0.1 - 38.2 | 50 | 0.99 | -0.05 | 0.998 |
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Reproducibilitv
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 1 | 0.073 | 0.003 | 3.8 | 0.005 | 7.36 |
| Serum Pool 2 | 0.43 | 0.005 | 1.25 | 0.014 | 3.18 |
| Serum Pool 3 | 22.5 | 0.237 | 1.05 | 0.499 | 2.22 |
| Serum Pool 4 | 30.55 | 0.310 | 1.0 | 0.975 | 3.76 |
| Biorad Cardiac | |||||
| Quality Control, | |||||
| Level 2 | 0.51 | 0.009 | 1.7 | 0.005 | 1.05 |
The reproducibility testing was conducted in accordance with the CLSI Approved Guideline for User Evaluation of Precision Performance of Clinical Chemistry Devices EPS-A2. For each test level, a single test from two independent cups was analyzed twice per day. The repeatability and within-lab standard deviations were calculated by the analysis of variance method.
Comments on Substantial Equivalence:
Both the predicate Dimension® CTNI reagent cartridge and the revised Dimension Vista™ CTNI immunoassays are intended for the quantitative determination of troponin I. Comparative data for human serum and heparinized plasma samples demonstrate good analytical agreement between the methods.
Conclusion:
The Dade Behring revised Dimension Vista™ CTNI and the predicate Dade Behring Dimension® CTNI immunoassays (K0101313) are substantially equivalent based on their intended use and performance characteristics as described above.
George M. Plummer Regulatory Affairs and Compliance Manager December 18, 2006
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle faces right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dade Behring, Inc. c/o George M. Plummer Bldg. 500 Mail Box 514 P.O. Box 6101 Newark, DE 19714-6101
MAR 1 9 2007
Re: K063756
Trade/Device Name: Dimension VISTA™ CTNI Flex® reagent cartridge Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system. Regulatory Class: Class II Product Code: MMI Dated: December 18, 2006 Received: December 19, 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 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 (QS) regulation (21 CFR Part 820).
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Page 2 -
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) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Jean M. Cooper, M.S., D.V.M.
Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (If Known):
X063756
Device(s) Name(s):
Dimension Vista™ CTNI Flex® reagent cartridge
Indications for Use:
The CTNI method is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in human serum and plasma 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.
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)
Carol Benson
ision Sign-Off
ffice of In Vitro Diagnostic Device valuation and Safety