DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692

K081643 · Siemens Healthcare Diagnostics · MMI · Jul 3, 2008 · Clinical Chemistry

Device Facts

• Record ID: K081643
• Device Name: DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692
• Applicant: Siemens Healthcare Diagnostics
• Product Code: MMI · Clinical Chemistry
• Decision Date: Jul 3, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

The TNI method is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in human serum and plasma on the Dimension® EXL™ integrated chemistry system with LOCI® module. Measurements of cardiac troponin I are used as an 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 Sample Diluent is an in vitro diagnostic product for manual dilution of samples with elevated cardiac troponin I results processed on the Dimension Vista® and Dimension® EXL TM integrated chemistry system with LOCI® module.

Device Story

Dimension® TNI Flex® reagent cartridge is an in vitro diagnostic immunoassay for cardiac troponin I (cTnI) measurement on the Dimension® EXL™ system. Uses LOCI® (Luminescent Oxygen Channeling Immunoassay) technology; sandwich chemiluminescent immunoassay. Input: human serum or plasma sample. Process: sample incubated with biotinylated anti-cTnI monoclonal antibody and Chemibeads (coated with second anti-cTnI antibody, containing chemiluminescent dye); Sensibeads (coated with streptavidin, containing photosensitizer dye) added to form bead-pair immunocomplexes. Illumination at 680 nm generates singlet oxygen from Sensibeads; diffuses to Chemibeads to trigger chemiluminescence. Output: signal measured at 612 nm, proportional to cTnI concentration. Used in clinical laboratory settings by trained personnel. Results aid clinicians in AMI diagnosis and patient risk stratification. CTNI Sample Diluent provided for manual dilution of samples with elevated cTnI levels.

Clinical Evidence

Bench testing only. Precision and method comparison studies performed against automated laboratory analyzer to validate performance characteristics of the reconfigured 8-well reagent cartridge.

Technological Characteristics

In vitro diagnostic reagent cartridge; 8-well configuration; immunoassay-based quantification; designed for use on Dimension EXL with LM system; design controls per 21 CFR 820.30.

Indications for Use

Indicated for use as an in vitro diagnostic reagent for the quantitative determination of Cardiac Troponin I (cTnI) in human serum and plasma on the Dimension Vista system.

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

• Dimension Vista® CTNI Flex® reagent cartridge (K063756)
• Dimension Vista® CTNI Sample Diluent (K053577)

Submission Summary (Full Text)

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### 510(k) Summary of Safety and Effectiveness Dimension® TNI Flex® reagent cartridge and CTNI Sample Diluent

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

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| The assigned 510(k) number is: | K081643 | |
|--------------------------------|---------|--|
|--------------------------------|---------|--|

#### 1. Submitter's Contact Information and Date of Preparation

| Submitter's Contact Information: | Mrs. Yuk-Ting Lewis<br>Siemens Healthcare Diagnostics Inc.<br>P.O. Box 6101<br>Newark, DE 19714<br>Tel: [phone] |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Date of Preparation: | June 3, 2008 |

#### Proprictary Device Name / FDA Classification Name 2.

| Dimension® TNI Flex® reagent cartridge | Immunoassay Method, Troponin submit<br>(21 CFR 862.1215) |
|----------------------------------------|----------------------------------------------------------|
| CTNI Sample Diluent | No FDA classification |

#### 3. Identification of the Predicate Device

Dimension Vista® CTNI Flex® reagent cartridge, K063756 Dimension Vista® CTNI Sample Difuent, K053577

#### 4. Device Description

The Dimension® TNI Flex® reagent cartridge is an in vitro diagnostic device that consists of prepackaged reagents in a plastic eight-well cartridge for use on the Dimension® EXL™ with LM system.

The TNI method is a homogeneous, sandwich chemiluminescent immunoassay based on LOCI® technology. The 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 photosensitizer 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 bead-cardiac troponin I-biotinylated antibody sandwiches.

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Sensibeads are addcd and bind to the biotin to form bead-pair immunocomplexes. Illumination of the complex at 680 nm generates singlet oxygen from Scnsibeads which diffuses into the Chemibeads, triggering a chemiluminescent reaction. The resulting signal is measured at 612 nm and is a direct function of the cardiac troponin I concentration in the sample.

The CTNI Sample Diluent is a liquid, human serum based product with prescrvatives.

#### 5. Device Intended Use

The TNI method is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in human serum and plasma on the Dimension® EXL™ integrated chemistry system with LOCI® module. Measurements of cardiac troponin I are used as an 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 Sample Diluent is an in vitro diagnostic product for manual dilution of samples with elevated cardiac troponin I results processed on the Dimension Vista® and Dimension® EXL TM integrated chemistry system with LOCI® module.

#### Summary of the devices technological characteristics 6.

The Dimension® TNI Flex® reagent cartridge has the same technological characteristics as the predicate device. A comparison of features is provided.

| Feature | Predicate Device:<br>Dimension Vista® CTNI Flex®<br>reagent cartridge | New Device:<br>Dimension® TNI Flex® reagent<br>cartridge |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Intended Use | Both devices are for in vitro diagnostic use for the quantitative measurement<br>of cardiac troponin I in human serum and plasma. | |
| Sample Type | Acceptable sample types are human serum and plasma. | |
| Assay Range | The Dimension Vista® CTNI<br>method has an assay range of<br>0.015-40 ng/mL. | The Dimension® TNI method has an<br>assay range of 0.017-40 ng/mL. |
| Technology | Both devices use LOCI® technology. | |
| Sample Size | Both devices use a sample volume of 20 µL. | |
| Reagents and<br>antibody | Both devices use the same liquid reagents and antibody. | |
| Diluent | Both devices use the CTNI Sample Diluent to manually dilute high samples. | |
| Instrument | The Dimension Vista® CTNI<br>Flex® is run on the Dimension<br>Vista® analyzer. | The Dimension® TNI Flex® is run<br>on the Dimension® EXLTM system<br>with the LOCI module. |

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#### 7. Method Comparison to the predicate

A split sample method comparison study was conducted on the Dimension® TNI Flex® vs. the Dimension® Vista CTNI Flex® reagent cartridge using two hundred-and-twenty nine (229) serum and plasma samples. The data was analyzed using least squares linear regression. The resulting regression statistics are shown below.

| Slope | 1.0325 |
|-------|---------------|
| y-int | -0.0284 ng/mL |
| r | 0.998 |
| n | 229 |

#### 8. Conclusion

・

Based on a review of the devices technological features and the method comparison study, the Dimension® TNI Flex® reagent cartridge is substantially equivalent to the legally marketed device, the Dimension Vista® CTNI Flex® reagent cartridge.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black. The overall design is simple and recognizable.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Siemens Healthcare Diagnostics, Inc. c/o Yuk-Ting Lewis RA & Compliance Manager P.O. Box 6101, M/S 514 Newark, DE 19714

JUL - 3 2008

Re: k081643 Trade/Device Name: Dimension® TNI Flex® reagent cartridge CTNI 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 Dated: June 11, 2008 Received: June 12, 2008

Dear Ms. Lewis:

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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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 yours,

Jean M. Cooper, M.S., D.V.M.

Yéan 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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# Indication for Use

510(k) Number (if known): K081643

Dimension® TNI Flex® reagent cartridge Device Name: CTNI Sample Diluent

Indications For Use:

### Method

The TNI method is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in human serum and plasma on the Dimension® EXL™ integrated chemistry system with LOCI® module. Measurements of cardiac troponin I are used as an 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.

### Diluent

The CTNI Sample Diluent is an in vitro diagnostic product for manual dilution of samples with elevated cardiac troponin I results processed on the Dimension Vista® and Dimension® EXL™ integrated chemistry system with LOCI® module.

Prescription Use X (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use _ (21 CFR Part 801 Subpart C)

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Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Carol C. Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K081643