DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360

K083579 · Siemens Healthcare Diagnostics · JIX · Feb 20, 2009 · Clinical Chemistry

Device Facts

• Record ID: K083579
• Device Name: DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360
• Applicant: Siemens Healthcare Diagnostics
• Product Code: JIX · Clinical Chemistry
• Decision Date: Feb 20, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The ENZ 6 CAL is an in vitro diagnostic product for the calibration of the Creatine Kinase (CKI) and Creatine Kinase MB (MBI) methods on the Dimension Vista® System. For prescription use. For use with the Siemens Dimension Vista® System

Device Story

The Dimension Vista® Enzyme 6 Calibrator is a liquid, multi-analyte, human serum albumin-based product containing human-source creatine kinase and porcine-source creatine kinase MB. It is used in clinical laboratory settings to calibrate CKI and MBI methods on the Dimension Vista® System. The calibrator kit consists of three vials of Calibrator A; purified water or reagent-grade water is used as Calibrator Level 1. By establishing a known reference point for the assay, the calibrator enables the system to accurately quantify analyte concentrations in patient samples, supporting clinical decision-making regarding cardiac or muscle-related conditions.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including manufacturing process validation, value assignment, and stability testing.

Technological Characteristics

Liquid, multi-analyte calibrator; human serum albumin matrix; contains human-derived CKMM and porcine-derived CKMB. Traceable to IFCC reference methods/materials. Storage: -20°C shelf life; 2-8°C after opening. Designed for use with Siemens Dimension Vista® System.

Indications for Use

Indicated for the calibration of Creatine Kinase (CKI) and Creatine Kinase MB (MBI) methods on the Dimension Vista® System for clinical laboratory use.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Dimension® CKI/MBI Calibrator (k081731)

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness for the Dimension Vista® System Enzyme 6 Calibrator (KC360)

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.

| A. 510(k) Number: | K083579 |
|-------------------|---------|
|-------------------|---------|

B. Date of Preparation: November 24, 2008

# C. Proprietary and Established Names:

Enzyme 6 Calibrator

#### D. Applicant:

Siemens Healthcare Diagnostics Inc., P.O. Box 6101, Newark, DE 19714-6101 Victor M. Carrio, Senior Manager, Regulatory Affairs Office: [phone] Fax: [phone]

#### E. Requiatory Information:

Regulation section: 21 CFR § 862.1150 Calibrator Classification: Class II Product Code: JIX, Calibrator, Multi-Analyte Mixture Panel: Clinical Chemistry

#### F. Predicate Devices: '

Dimension® CKI/MBI Calibrator (K081731)

#### G. Device Description:

The Dimension Vista® System Enzyme 6 Calibrator (Enz 6 CAL) is a liquid, multianalyte, human serum albumin based product containing creatine kinase MM (human source) and creatine kinase MB (porcine source). The kit consists of three vials of Calibrator A, 2.0 ml per vial. Level 1 calibrator for Enz 6 CAL is not included. Purified Water Diluent or reagent grade water is required for use as Calibrator Level 1. Description of the manufacturing, value assignment and stability testing process are provided in this submission report.

#### H. Intended Use:

The ENZ 6 CAL is an in vitro diagnostic product for the calibration of the Creatine Kinase (CKI) and Creatine Kinase MB (MBI) methods on the Dimension VIsta® System.

#### I. Substantial Equivalence Information:

The Dimension Vista® Enzyme 6 Calibrator (KC360) was compared to the Dimension® CKI/MBI Calibrator (K081731). A comparison of the important similarities and differences between the device and the predicate is provided in the following table:

| Feature | Dimension Vista® Enzyme 6<br>Calibrator | Dimension® CKI/MBI<br>Calibrator (K081731) |
|--------------|-------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Intended Use | The ENZ 6 CAL is an in vitro<br>diagnostic product for the<br>calibration of the Creatine | The CKI/MBI CAL is an in vitro<br>diagnostic product for the<br>calibration of the Creatine |

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| | Kinase (CKI) and Creatine<br>Kinase MB (MBI) methods on<br>the Dimension Vista® System. | Kinase (CKI) and Creatine<br>Kinase MB (MBI) methods on<br>the Dimension® clinical<br>chemistry system. |
|---------|-----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Analyte | Creatine kinase (human<br>source) and creatine kinase-MB<br>(porcine source) | Creatine kinase (human<br>source) and creatine kinase-MB<br>(porcine source) |
| Matrix | Human serum albumin | Human serum albumin |
| Form | Liquid | Liquid |
| Levels | CKI — Two levels<br>MBI — Two levels | CKI - Three levels<br>MBI - Five levels |

## J. Conclusion:

.

.

:

.

。

The Dimension Vista® Enzyme 6 Calibrator (KC360) is substantially equivalent to the Dimension® CKI/MBI Calibrator (K081731). Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance.

,

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird-like figure.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Siemens Healthcare Diagnostics Inc. c/o Mr. Victor M. Carrio Senior Manager Regulatory Affairs P.O. Box 6101 Newark, DE 19714-6101

FEB 2 0 2009

## Re: k083579

Trade/Device Name: Dimension Vista® Enzyme 6 Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator, Multi-Analyte Regulatory Class: Class II Product Code: JIX Dated: December 3, 2008 Received: December 4, 2008

Dear Mr. Carrio:

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 of the contra ಿ ಮಾರ್ ರೇಸ್ ನಿರ್ವಹಿಸಿ ಪ್ರಮುಖ http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Corg C. He

Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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# Indication for Use

K083579 510(k) Number (if known):

Device Name:

Dimension Vista® Enzyme 6 Calibrator

Indication For Use:

The ENZ 6 CAL is an in vitro diagnostic product for the calibration of the Creatine Kinase (CKI) and Creatine Kinase MB (MBI) methods on the Dimension Mista® System.

Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or

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

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concerrence of CDRH) Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) 1

Violet May

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

510(k) K083579