DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE

K063756 · Dade Behring, Inc. · MMI · Mar 19, 2007 · Clinical Chemistry

Device Facts

• Record ID: K063756
• Device Name: DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE
• Applicant: Dade Behring, Inc.
• Product Code: MMI · Clinical Chemistry
• Decision Date: Mar 19, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended 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.

Device Story

The Dimension Vista™ CTNI Flex® reagent cartridge is an in vitro diagnostic assay for measuring cardiac troponin I in human serum and plasma. It utilizes LOCI™ (Luminescent Oxygen Channeling Immunoassay) technology, a one-step sandwich chemiluminescent immunoassay. The system uses two synthetic bead reagents: Sensibeads (streptavidin-coated with photosensitive dye) and Chemibeads (coated with anti-cardiac troponin I monoclonal antibody and chemiluminescent dye). Upon incubation with the sample and biotinylated antibody, bead-aggregated immunocomplexes form. Illumination at 680 nm triggers singlet oxygen release from Sensibeads, which diffuses to Chemibeads to initiate a chemiluminescent reaction measured at 612 nm. The signal intensity is directly proportional to the cardiac troponin I concentration. The device is intended for use on the Dimension Vista® System in clinical laboratory settings. Healthcare providers use the quantitative results to assist in diagnosing AMI and assessing mortality risk in patients with acute coronary syndromes, facilitating timely clinical intervention.

Clinical Evidence

Bench testing only. Method comparison study (n=91) between Dimension Vista™ and predicate showed slope 0.99, intercept -0.10, correlation coefficient 0.993. Serum vs. plasma comparison (n=63) showed slope 1.02, intercept 0.031, r=0.999. Lithium vs. sodium heparin plasma comparison (n=50) showed slope 0.99, intercept -0.05, r=0.998. Reproducibility testing followed CLSI EPS-A2 guidelines; reported CVs ranged from 1.0% to 7.36% across various concentration levels.

Technological Characteristics

Chemiluminescent immunoassay using LOCI™ technology. Reagents: streptavidin-coated Sensibeads (photosensitive dye) and anti-cardiac troponin I monoclonal antibody-coated Chemibeads (chemiluminescent dye). Energy source: 680 nm illumination; signal detection at 612 nm. Sample volume: 20 µL. Calibration: six levels every 30 days. System: Dimension Vista®.

Indications for Use

Indicated for quantitative measurement of cardiac troponin I in human serum and plasma to aid in diagnosis of acute myocardial infarction (AMI) and risk stratification of patients with acute coronary syndromes regarding mortality risk.

Regulatory Classification

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.

Predicate Devices

• Dade Behring Dimension® CTNI immunoassay (K0101313)

Submission Summary (Full Text)

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K063756

# 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<br>Dade Behring Inc.<br>P.O. Box 6101<br>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 <i>in vitro</i> quantitative<br>determination of cardiac<br>troponin -I in human serum and<br>heparinized plasma as an aid in<br>the diagnosis of myocardial<br>infarction and in the risk<br>stratification of patients with<br>acute coronary syndromes with<br>respect to their relative risk of<br>mortality. | For the <i>in vitro</i> quantitative<br>determination of cardiac troponin -I in<br>human serum and heparinized plasma<br>as an aid in the diagnosis of myocardia<br>infarction and in the risk stratification<br>of patients with acute coronary<br>syndromes with respect to their relativ<br>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<br>monoclonal | Dade Behring mouse monoclonal |
| Analytical Sensitivity | 0.04 ng/mL | 0.015 ng/mL |
| Functional<br>Sensitivity | Not specified | 0.04 ng/mL |
| Analytical Specificity | Cross reactivity at 1000 ng/mL<br>with skeletal muscle troponin-I,<br>cardiac troponin -T and cardiac<br>troponin-C is 0.04 ng/mL, 0.34<br>ng/mL and 0 ng/mL<br>respectively. | Cross reactivity at 1000 ng/mL with<br>skeletal muscle troponin-I, cardiac<br>troponin --T and cardiac troponin-C is<br>0.14 ng/mL, 0.05 ng/mL and 0 ng/mL<br>respectively. |
| Hook Effect | No high dose effect<br>up to 1800 ng/mL | No high dose effect up to 1000 ng/mL |
| Calibration Interval | Calibration curve updated for<br>each lot, using five levels and<br>every 60 days, thereafter with<br>the same reagent lot. | Calibration curve updated for each lot,<br>using six levels every 30 days with the<br>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®<br>Sample<br>Range | Dimension<br>Vista® Sample<br>Range | n | Slope | Intercept | Correlation<br>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<br>Range | Serum Sample<br>Range | n | Slope | Intercept | Correlation<br>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<br>Sample Range | Na Heparin<br>Sample Range | n | Slope | Intercept | Correlation<br>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<br>Quality Control,<br>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 [phone]. 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 [phone] or [phone] 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

K063756