DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE

K083465 · Siemens Healthcare Diagnostics · CGS · Feb 27, 2009 · Clinical Chemistry

Device Facts

• Record ID: K083465
• Device Name: DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE
• Applicant: Siemens Healthcare Diagnostics
• Product Code: CGS · Clinical Chemistry
• Decision Date: Feb 27, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

The CKI method is an in vitro diagnostic test for the quantitative measurement of creatine kinase in human serum and plasma on the Dimension Vista® chemistry system. 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. The creatine kinase MB (MBI) method is an in vitro diagnostic test for the quantitative measurement of creatine kinase MB isoenzyme activity in human serum and plasma on the Dimension Vista® clinical chemistry system. 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.

Device Story

Reagent cartridges for Dimension Vista clinical chemistry system; perform in vitro quantitative measurement of CK and CK-MB activity in human serum/plasma. CKI method: coupled enzyme reaction; CK catalyzes transphosphorylation of creatine phosphate to ADP, producing ATP; hexokinase uses ATP to phosphorylate glucose; G-6-PDH oxidizes resulting glucose-6-phosphate with simultaneous reduction of NADP to NADPH. MBI method: antibody inhibits CK-M subunit; CK-B activity measured via similar coupled enzyme reaction. Rate of NADPH formation measured bichromatically at 340 and 540 nm; proportional to CK/CK-B activity. Used in clinical laboratory settings by trained personnel. Output provides quantitative enzyme activity levels to clinicians for diagnosis and management of myocardial infarction and muscular dystrophies.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control procedures (21 CFR 820.30) to confirm that modifications to reagent volume and instrument platform did not impact device performance.

Technological Characteristics

Reagent test cartridge; modified for Dimension Vista instrument platform. Fundamental scientific technology identical to predicate. Design controls applied per 21 CFR 820.30.

Indications for Use

Indicated for quantitative measurement of creatine kinase (CK) and creatine kinase MB (CK-MB) isoenzyme activity in human serum and plasma to aid in the diagnosis and treatment of myocardial infarction and muscle diseases, including progressive Duchenne-type muscular dystrophy.

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® (CKI) Flex® Reagent Cartridge (DF38) (K081731)
• Dimension® (MBI) Flex® Reagent Cartridge (DF32) (K081731)

Submission Summary (Full Text)

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510(k) Summary of Safety and Effectiveness for the Dimension Vista® Creatine Kinase Flex® Reagent Cartridge (K2038) Dimension Vista® Creatine Kinase MB Flex® Reagent Cartridge (K2032)

1083463

FEB & 7 2009

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: K083465

B. Date of Preparation: November 18, 2008

C. Proprietary and Established Names:

Dimension Vista® Creatine Kinase (CKI) Flex® Reagent Cartridge (K2038) Dimension Vista® Creatine Kinase MB (MBI) Flex® Reagent Cartridge (K2032)

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]

F. Regulatory Information:

Dimension Vista® Creatine Kinase (CKI) Flex® Reagent Cartridge (K2038)

1. Regulation section: 21 CFR § 862.1215 - Creatine phosphokinase/creatine kinase or isoenzymes test system

2. Classification: Class II

3. Product Code: CGS. Nad reduction/nadh oxidation, cpk or isoenzymes

4. Panel: Clinical Chemistrv

Dimension Vista® Creatine Kinase MB (MBI) Flex® Reagent Cartridge (K2032)

1. Regulation section: 21 CFR § 862.1215 - Creatine phosphokinase/creatine kinase or isoenzymes test system

2. Classification: Class II

3. Product Code: JHS, Differential rate kinetic method, cpk or isoenzymes

4. Panel: Clinical Chemistry

F. Predicate Devices:

Dimension® (CKI) Flex® Reagent Cartridge (DF38) - K081731 Dimension® (MBI) Flex® Reagent Cartridge (DF32) - K081731

G. Device Description:

#### Dimension Vista® (CKI) Flex® Reagent Cartridge (K2038)

In a coupled enzyme reaction, the creatine kinase in patient samples catalyzes the transphosphorylation of phosphate from creatine phosphate to adenosine-diphosphate

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(ADP) producing adenosine-triphosphate (ATP). Hexokinase (HK) phosphorylates glucose from the ATP to phosphorylate glucose. The resulting glucose-6-phosphate is oxidized by glucose-6-phosphate dehydrogenase (G-6-PDH) with the simultaneous reduction of nicotinamide adenine dinucleotide phosphate (NADP). The rate of formation of NADPH is directly proportional to the CK activity in the sample and is measured bichromatically at 340 and 540 nm.

#### Dimension Vista® (MBI) Flex® Reagent Cartridge (K2032)

The activity of the CK-MM isoenzyme is inhibited by an antibody specific for the CK-M subunit. The activity of the B subunit of creatine kinase MB isoenzyme is not inhibited, and it is on this basis that CK-MB can be measured.

In an enzyme coupled reaction, creatine kinase in patient samples catalyzes the transphosphorylation of creatine phosphate to adenosine-diphosphate (ADP), producing adenosine-triphosphate (ATP). Hexokinase (HK) uses the ATP to phosphorylate glucose. The resulting glucose-6-phosphate is oxidized by glucose-6-phosphate dehydrogenase (G-6-PDH) with the simultaneous reduction of nicotinamide adenine dinucleotide phosphate (NADP) to NADPH.

The rate of formation of NADPH is measured bichromatically at 340, 540 nm and is directly proportional to CK-B activity in the sample

H. Intended Use:

Dimension Vista® (CKI) Flex® Reagent Cartridge (K2038)

The CKI method is an in vitro diagnostic test for the quantitative measurement of creatine kinase in human serum and plasma on the Dimension® clinical chemistry system. 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.

Dimension® (MBI) Flex® Reagent Cartridge (K2032)

The creatine kinase MB (MBI) method is an in vitro diagnostic test for the quantitative measurement of creatine kinase MB isoenzyme activity in human serum and plasma on the Dimension® clinical chemistry system. 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.

I. Substantial Equivalence Information:

The Dimension Vista® (CKI) Flex® Reagent Cartridge (K2038) and (MBI) Flex® Reagent Cartridge (K2032) were compared to the Dimension® predicate devices CKI (DF38) and MBI (DF32) previously cleared under K081731. A comparison of the important similarities and differences between the devices and the predicates is provided in the following tables:

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| Feature | Dimension Vista® (CKI) Flex®<br>Reagent Cartridge (K2038) | Dimension® (CKI) Flex® Reagent<br>Cartridge (DF38) K081731 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The CKI method is an in vitro<br>diagnostic test for the quantitative<br>measurement of creatine kinase in<br>human serum and plasma on the<br>Dimension Vista® Clinical Chemistry<br>System. | The CKI method is an in vitro<br>diagnostic test for the quantitative<br>measurement of creatine kinase in<br>human serum and plasma on the<br>Dimension® Clinical Chemistry System. |
| Device<br>Technology(detection) | Bichromatic rate | Bichromatic rate |
| Measuring Range | 7 - 1000 U/L | 7 - 1000 U/L |
| Limit of Detection | 7 U/L | 7 U/L |
| Feature | Dimension Vista® (MBI) Flex®<br>Reagent Cartridge (K2032) | Dimension® (MBI) Flex® Reagent<br>Cartridge (DF32) K081731 |
| Intended Use | The creatine kinase MB (MBI)<br>method is an in vitro diagnostic test<br>for the quantitative measurement of<br>creatine kinase MB isoenzyme<br>activity in human serum and plasma<br>on the Dimension Vista® clinical<br>chemistry system. | The creatine kinase MB (MBI) method<br>is an in vitro diagnostic test for the<br>quantitative measurement of creatine<br>kinase MB isoenzyme activity in human<br>serum and plasma on the Dimension®<br>clinical chemistry system. |
| Device Technology<br>(detection) | Bichromatic rate | Bichromatic rate |
| Measuring Range | 3 - 125 U/L | 3 - 125 U/L |
| Analytical Sensitivity | 3 U/L | 3 U/L |

## J. Conclusion:

The Dimension Vista® CKI (K2038) and MBI (K2032) Flex® Reagent Cartridges are substantially equivalent to the Dimension® CKI (DF38) and MBI (DF32) Flex® Reagent Cartridges previously cleared under K081731. Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an eagle-like emblem with three stylized wing segments. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

#### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Siemens Healthcare Diagnostics Inc. c/o Mr. Victor M. Carrio Senior Manager, RA P.O. Box 6101, Mail Box 514 Newark, DE 19714-6101

FEB 2 7 2009

Re: k083465

> Trade/Device Name: Dimension Vista® (CKI) Flex® Reagent Cartridge Dimension Vista® (MBI) 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: CGS, JHS Dated: January 27, 2009 Received: January 28, 2009

#### 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 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

510(k) Number (if known): K083465

Device Name:

Dimension Vista® (MBI) Flex® Reagent Cartridge

Indication For Use:

The creatine kinase MB (MBI) method is an in vitro diagnostic test for the quantitative measurement of creatine kinase MB isoenzyme activity in human serum and plasma on the Dimension Vista® clinical chemistry system. 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.

Dimension Vista® (CKI) Flex® Reagent Cartridge

Indication For Use:

The CKI method is an in vitro diagnostic test for the quantitative measurement of creatine kinase in human serum and plasma on the Dimension Vista® chemistry system. 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.

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)

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

Rute chula

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

510(k) k083465