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.

The CTNI CAL is an in vitro diagnostic product for the calibration of cardiac Troponin-1 (CTNI) on the Dimension Vista™ system.

For use on the Dimension Vista™ System to dilute samples with elevated CTNI results.

Device Description

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.

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).

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.

AI/ML Overview

This document describes the safety and effectiveness of the Dimension Vista™ CTNI Flex® reagent cartridge, Dimension Vista™ CTNI Calibrator, and Dimension Vista™ CTNI SDIL Sample Diluent. The device is intended for the quantitative measurement of cardiac troponin I in human serum to aid in the diagnosis of acute myocardial infarction (AMI) and in the risk stratification of patients with acute coronary syndromes.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance is primarily demonstrated through a comparison to a predicate device (Dade Behring Dimension® CTNI). The acceptance criteria are implicitly established by showing "good agreement" and "substantially equivalent" performance to the predicate device in various analytical aspects.

Acceptance Criteria (Implicit - based on predicate device performance)	Reported Device Performance (Dimension Vista™ CTNI)
Intended Use	Quantitative measurement of cardiac Troponin I in human serum; aid in diagnosis of AMI and risk stratification of acute coronary syndromes.
Assay Type	Chemiluminescent immunoassay
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/mLCardiac troponin -T: 0.06 ng/mLCardiac troponin-C: 0 ng/mL
Interferences (No significant interference from)	Bilirubin, conjugated up to 40 mg/dLBilirubin, unconjugated up to 40 mg/dLHemoglobin up to 500 mg/dLTriglycerides up to 3000 mg/dL
Hook Effect	No high dose effect up to 1000 ng/mL
Calibration Interval	Calibration curve updated for each lot, using six levels every 30 days with the same reagent lot.
Sample Volume	20 uL
Method Comparison (Correlation with predicate device)	Slope: 1.015Intercept: -0.003 ng/mLCorrelation Coefficient: 0.993
Reproducibility (%CV)	Repeatability (Within-run):Level 1 (0.123 ng/mL): 4.21%Level 2 (0.55 ng/mL): 2.28%Level 3 (24.51 ng/mL): 4.13%Level 4 (31.41 ng/mL): 3.0%
	Within Lab (Total CV):Level 1 (0.123 ng/mL): 5.77%Level 2 (0.55 ng/mL): 2.93%Level 3 (24.51 ng/mL): 4.60%Level 4 (31.41 ng/mL): 3.76%

2. Sample Size Used for the Test Set and Data Provenance

Method Comparison Test Set:
- Sample Size: 197 serum patient samples.
- Data Provenance: Not explicitly stated, but implied to be human serum patient samples collected for method comparison, likely retrospective, given the use of linear least squares regression analysis on a range of values. The country of origin is not specified.
Reproducibility Test Set:
- Sample Size: Not explicitly stated as individual patient samples. "Serum Pool" at different levels were used. For each test level, a single test from two independent cups was analyzed twice per day. The guideline CLSI/NCCLS EP5-A2 typically involves multiple runs over several days/weeks.
- Data Provenance: Not specified. Likely laboratory-prepared serum pools.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This device is an in vitro diagnostic test for quantitative measurement and its performance is assessed against a predicate device and analytical targets, not by expert consensus on diagnoses for individual cases.

4. Adjudication Method for the Test Set

Not applicable. The test set involved quantitative measurements and comparison to a predicate device, not qualitative assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an in vitro diagnostic assay, not an imaging device or AI-assisted diagnostic tool that would involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the studies described (Method Comparison, Reproducibility) represent the standalone performance of the Dimension Vista™ CTNI method. The device provides a quantitative measurement of cardiac troponin I, and its performance is evaluated based on its accuracy, precision, and agreement with a predicate device, without direct human intervention in the measurement process itself beyond standard laboratory procedures.

7. The Type of Ground Truth Used

Method Comparison: The "ground truth" for the method comparison study was established by the predicate device (Dade Behring Dimension® CTNI immunoassay). The goal was to demonstrate agreement with an already legally marketed and accepted device.
Reproducibility: The "ground truth" was the expected concentration of cardiac troponin I in the serum pools, against which the device's precision (repeatability and within-lab variability) was assessed. These known concentrations would have been established through a reference method or careful preparation.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set in the conventional sense. This is an immunoassay, and its development involves reagent optimization and calibration procedures rather than algorithm training.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set in the context of an immunoassay. The development of such a device involves:

Reagent development and optimization: This involves titrations, interference studies, and ensuring proper antibody binding.
Calibration: This involves using known standards (calibrators) to establish a standard curve from which unknown sample concentrations are calculated. The calibrators contain a human troponin complex in a human serum matrix with stabilizers and preservatives, with defined concentrations.

Summary

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K053577

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. PlummerDade Behring Inc.P.O. Box 6101Newark, DE 19714-6101
Date of Preparation:	December 20, 2005
Name of Product(s):	Dimension Vista™ CTNI Flex® reagent cartridgeDimension Vista™ CTNI CalibratorDimension Vista™ CTNI SDIL Sample Diluent
FDA Classification Name(s):	Immunoassay method, Troponin subunit (862.1215), secondarycalibrator (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

Calibrator

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.

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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 quantitativedetermination of cardiac troponin-I in human serum andheparinized plasma as an aid inthe diagnosis of myocardialinfarction and in the riskstratification of patients withacute coronary syndromes withrespect to their relative risk ofmortality.	The CTNI method is an in vitrodiagnostic test for the quantitativemeasurement of cardiac troponin I inhuman serum on the Dimension Vista™System. Measurements of cardiactroponin I are used to aid in thediagnosis of acute myocardial infarction(AMI) and in the risk stratification ofpatients with acute coronary syndromeswith respect to their relative risk ofmortality.
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
AnalyticalSensitivity	0.04 ng/mL	0.015 ng/mL

Method:

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FunctionalSensitivity	Not specified	0.04 ng/mL
AnalyticalSpecificity	Cross reactivity at 1000 ng/mLwith skeletal muscle troponin-I,cardiac troponin -T and cardiactroponin-C is 0.04 ng/mL, 0.34ng/mL and 0 ng/mLrespectively.	Cross reactivity at 1000 ng/mL withskeletal muscle troponin-I, cardiactroponin -T and cardiac troponin-C is0.12 ng/mL, 0.06 ng/mL and 0 ng/mLrespectively.
Interferences	No significant interference from:bilirubin up to 20 mg/dL,hemoglobin up to 1000 mg/dLand triglycerides up to 3000mg/dL	No significant interference from:bilirubin, conjugated up to 40 mg/dLbilirubin, unconjugated up to 40 mg/dL,hemoglobin up to 500 mg/dL andtriglycerides up to 3000 mg/dL.
Hook Effect	No high dose effect up to 1800ng/mL	No high dose effect up to 1000 ng/mL
Calibration Interval	Calibration curve updated foreach lot, using five levels andevery 60 days, thereafter withthe same reagent lot.	Calibration curve updated for each lot,using six levels every 30 days with thesame 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 mLLevel 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
SerumPool,Level 1	0.123	0.005	4.21	0.007	5.77
SerumPool,Level 2	0.55	0.012	2.28	0.016	2.93
SerumPool,Level 3	24.51	1.012	4.13	1.167	4.60
SerumPool,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.

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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

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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).

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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

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INDICATIONS FOR USE STATEMENT

510(k) Number (If Known):

K053577

Device(s) Name(s):

Dimension Vista™ CTNI Flex® reagent cartridge Dimension Vista™ CTNI Calibrator Dimension Vista™ CTNI SDIL Sample Diluent

Indications for Use:

Method:

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)

GAC

Jivision Sign-Off

Office\of In Vitro Diagnostic Device Evaluation and Sare

Regulation Number and Section

§ 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.