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.

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.

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 (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.

AI/ML Overview

This document describes the 510(k) summary for the Dimension Vista® Creatine Kinase Flex® and Creatine Kinase MB Flex® Reagent Cartridges (K2038 and K2032, respectively).

Here's an analysis of the provided text to extract the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document establishes substantial equivalence by comparing the performance characteristics of the new Dimension Vista® cartridges with their predicate devices, Dimension® CKI (DF38) and MBI (DF32) Flex® Reagent Cartridges (K081731). The acceptance criteria are implicitly defined by the performance of the predicate device, and the new devices are deemed to "demonstrate substantial equivalent performance."

Feature	Acceptance Criteria (Predicate Device Performance)	Reported Device Performance (Dimension Vista®)
CKI Reagent (K2038)
Intended Use	Quantitative measurement of creatine kinase in human serum and plasma on the Dimension® Clinical Chemistry System.	Quantitative measurement of creatine kinase in human serum and plasma on the Dimension Vista® Clinical Chemistry System.
Device 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
MBI Reagent (K2032)
Intended Use	Quantitative measurement of creatine kinase MB isoenzyme activity in human serum and plasma on the Dimension® clinical chemistry system.	Quantitative measurement of creatine kinase MB isoenzyme activity in human serum and plasma on the Dimension Vista® clinical chemistry system.
Device Technology (detection)	Bichromatic rate	Bichromatic rate
Measuring Range	3 - 125 U/L	3 - 125 U/L
Analytical Sensitivity	3 U/L	3 U/L

2. Sample size used for the test set and the data provenance:

The document states, "Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance." However, it does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin of the data, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. For in vitro diagnostic tests like these, "ground truth" is typically established by reference methods or validated laboratory results, not by human expert interpretation of images or other subjective data.

4. Adjudication method for the test set:

This information is not applicable as the "test set" in this context refers to clinical samples analyzed by the device, not data requiring expert 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:

This is not applicable as the device is a reagent cartridge for an in vitro diagnostic assay, not an AI-powered diagnostic imaging tool that would involve human readers.

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

The device is inherently a "standalone" system in the sense that it performs the measurement algorithmically without a human actively interpreting its real-time output for a diagnostic decision in the same way an AI for image analysis would. The device generates quantitative results, which are then used by clinicians for diagnosis and treatment. Therefore, the performance presented is standalone performance of the reagent cartridges on the Dimension Vista® system.

7. The type of ground truth used:

The "ground truth" for evaluating these reagent cartridges would typically be established by:

Reference methods: Highly accurate and precise laboratory methods for measuring Creatine Kinase (CK) and Creatine Kinase MB (CK-MB).
Validated laboratory results: Measurements obtained using existing, cleared devices that are considered reliable standards.

The document implicitly refers to this by stating "comparative testing" with the predicate devices, meaning the predicate device results served as the reference for determining substantial equivalence.

8. The sample size for the training set:

This information is not provided in the document. For in vitro diagnostic reagents, there isn't a "training set" in the machine learning sense. The "development" or "optimization" phase would involve testing various formulations and conditions, but this is not typically referred to as a "training set" with explicit sample sizes in the regulatory submission summary for such devices.

9. How the ground truth for the training set was established:

This information is not provided and is generally not applicable in the context of traditional in vitro diagnostic reagent development in the same way it would be for an AI algorithm. The "ground truth" would be established by the rigorous chemical and enzymatic principles underlying the assay and validated against known standards and reference materials during the development and manufacturing process.

Summary

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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: (302) 631-0376 Fax: (302) 631-6299

F. Regulatory Information:

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

Regulation section: 21 CFR § 862.1215 - Creatine phosphokinase/creatine kinase or isoenzymes test system
Classification: Class II
Product Code: CGS. Nad reduction/nadh oxidation, cpk or isoenzymes
Panel: Clinical Chemistrv

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

Regulation section: 21 CFR § 862.1215 - Creatine phosphokinase/creatine kinase or isoenzymes test system
Classification: Class II
Product Code: JHS, Differential rate kinetic method, cpk or isoenzymes
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®Reagent Cartridge (K2038)	Dimension® (CKI) Flex® ReagentCartridge (DF38) K081731
Intended Use	The CKI method is an in vitrodiagnostic test for the quantitativemeasurement of creatine kinase inhuman serum and plasma on theDimension Vista® Clinical ChemistrySystem.	The CKI method is an in vitrodiagnostic test for the quantitativemeasurement of creatine kinase inhuman serum and plasma on theDimension® Clinical Chemistry System.
DeviceTechnology(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®Reagent Cartridge (K2032)	Dimension® (MBI) Flex® ReagentCartridge (DF32) K081731
Intended Use	The creatine kinase MB (MBI)method is an in vitro diagnostic testfor the quantitative measurement ofcreatine kinase MB isoenzymeactivity in human serum and plasmaon the Dimension Vista® clinicalchemistry system.	The creatine kinase MB (MBI) methodis an in vitro diagnostic test for thequantitative measurement of creatinekinase MB isoenzyme activity in humanserum and plasma on the Dimension®clinical chemistry system.
Device Technology(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 (301) 594-3084. 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/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:

Dimension Vista® (CKI) Flex® Reagent Cartridge

Indication For Use:

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)

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

510(k) K083465

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.