The Creatine Kinase assay is used for the quantitation of creatine kinase in human serum or plasma on the AEROSET™ instrument. Measurement of creatine kinase is used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Device Description

Creatine Kinase is an in vitro diagnostic assay for the quantitative determination of creatine kinase in human serum or plasma. The Creatine Kinase assay is a clinical chemistry assay in which the creatine kinase present in the sample catalyzes the transfer of a high energy phosphate group from creatine phosphate to ADP. The ATP produced in this reaction is subsequently used to phosphorylate glucose to produce glucose-6-phosphate (G-6-P) in the presence of hexokinase. G-6-P is then oxidized by glucose-6-phosphate dehydrogenase (G-6-PDH) with the concomitant reduction of NADP to NADPH. The rate of formation of NADPH is monitored at 340 nm and is proportional to the activity of creatine kinase in the sample.

AI/ML Overview

Here's an analysis of the provided information regarding the Creatine Kinase assay, focusing on its acceptance criteria and the study that proves it meets those criteria:

Acceptance Criteria and Device Performance for Creatine Kinase Assay

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Metric	Acceptance Criteria (Implicit)	Reported Device Performance
Method Comparison (vs. Predicate)	Correlation Coefficient	High correlation (e.g., >0.95)	0.999
	Slope	Close to 1 (e.g., 0.95 - 1.05)	0.988
	Y-intercept	Close to 0	-0.829 U/L
Precision	Total %CV (Level 1)	Low (e.g., <5%)	3.5%
	Total %CV (Level 2)	Low (e.g., <5%)	4.6%
Linearity	Upper Limit	Within clinically relevant range	Up to 7,150 U/L
Sensitivity	Limit of Quantitation	Low enough for clinical utility	4.7 U/L

Note: The acceptance criteria are implicitly derived from the statement "These data demonstrate that the performance of the Creatine Kinase assay is substantially equivalent to the performance of the Boehringer Mannheim CK/NAC assay on the Hitachi 717 Analyzer." The specific numerical thresholds are inferred based on common industry standards for demonstrating substantial equivalence for in vitro diagnostic assays.

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the method comparison or precision studies. It mentions "two levels of control material" for precision.

The data provenance is not specified regarding the country of origin. The studies were retrospective, as they were conducted to demonstrate equivalence to an existing, legally marketed device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Experts

This information is not applicable (N/A). This device is an in vitro diagnostic assay directly measuring an analyte (creatine kinase) in biological samples. The "ground truth" for method comparison and performance evaluation in this context is the results obtained from the predicate device (Boehringer Mannheim CK/NAC assay on the Hitachi 717 Analyzer) and traceable reference materials or control samples. Human expert interpretation of images or clinical cases is not involved in establishing the ground truth for this type of device.

4. Adjudication Method for the Test Set

This information is not applicable (N/A). Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation (e.g., radiology reads) to resolve discrepancies. For this quantitative assay, the comparison is directly against the predicate device's results and specified ranges for linearity and sensitivity, not against human judgment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for devices that involve human interpretation or decision-making aided by AI. The Creatine Kinase assay is a quantitative in vitro diagnostic device, not an AI-assisted diagnostic tool for human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the performance described is a standalone performance. The Creatine Kinase assay itself, an in vitro diagnostic chemical reaction, operates independently to produce a quantitative result. There is no "human-in-the-loop" performance in the sense of a human interpreting the device's output and making a diagnosis where the device is an "aid." The device directly provides the quantitative measurement of Creatine Kinase.

7. The Type of Ground Truth Used

The ground truth used for this study includes:

Predicate Device Results: The Boehringer Mannheim CK/NAC assay on the Hitachi 717 Analyzer served as the reference standard for the method comparison study. The output of this predicate device was considered the "ground truth" for comparison.
Control Material/Reference Standards: For precision, linearity, and sensitivity studies, the ground truth would be established through commercially available control materials with known Creatine Kinase concentrations or through precisely prepared reference standards.

8. The Sample Size for the Training Set

This information is not applicable (N/A). The Creatine Kinase assay is a chemical assay, not a machine learning or AI-based algorithm that requires a "training set" in the conventional sense. The "development" of such an assay involves chemical optimization and validation, not statistical training on a dataset.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable (N/A), as there is no "training set" for this type of device.

Summary

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510(k) Summary

Submitter's Name/Address

Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038 Contact Person Linda Morris Senior Regulatory Specialist MS 1-8 Regulatory Affairs (972) 518-6711 Fax (972) 753-3367

Date of Preparation of this Summary:	September 1, 1998
Device Trade or Proprietary Name:	CK
Device Common/Usual Name or Classification Name:	Creatine Kinase
Classification Number/Class:	Class II

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.

The assigned 510(k) number is:

Test Description:

Creatine Kinase 510(k) September 1, 1998 CK_5_V1.lwp

Section II Page 1

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Substantial Equivalence:

The Creatine Kinase assay is substantially equivalent to the following device: Boehringer Mannheim® CK/NAC assay (K782156) on the Hitachi® 717 Analyzer. Both assays vield similar Performance Characteristics.

Similarities:

. Both assays are in vitro clinical chemistry methods.
Both assays can be used for the quantitative determination of creatine kinase. .
. Both assays yield similar clinical results.

Differences:

. There is a difference between the assay range.

Intended Use:

The Creatine Kinase assay is used for the quantitation of creatine kinase in human serum or plasma on the AEROSET™ instrument.

Performance Characteristics:

Comparative performance studies were conducted using the AEROSET™ System. The Creatine Kinase assay method comparison vielded acceptable correlation with the Boehringer Mannheim CK/NAC assay on the Hitachi 717 Analyzer. The correlation coefficient = 0.999, slope = 0.988, and Y -intercept = - 0.829 U/L. Precision studies were conducted using the Creatine Kinase assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 101 is 3.5% and Level 2/Panel 102 is 4.6%. The Creatine Kinase assay is linear up to 7,150 U/L. The limit of quantitation (sensitivity) for the Creatine Kinase assay is 4.7 U/L. These data demonstrate that the performance of the Creatine Kinase assay is substantially equivalent to the performance of the Boehringer Mannheim CK/NAC assay on the Hitachi 717 Analyzer.

Creatine Kinase 510(k) September 1, 1998 CK_S_VI lwp

Section II Page 2

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Conclusion:

The Creatine Kinase assay is substantially equivalent to the Boehringer Mannheim CK/NAC assay on the Hitachi 717 Analyzer as demonstrated by results obtained in the studies.

Creatine Kinase 510(k) September 1, 1998
CK_5_VI.Iwp

Section II
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Public Health Service

FEB 1 6 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Linda Morris Senior Requlatory Specialist Abbott Laboratories 1920 Hurd Drive 75038 Irving, Texas

Re : K983070 Trade Name: Creatine Kinase Requlatory Class: II Product Code: 75 CGS December 28, 1998 Dated: December 29, 1998 Received:

Dear Ms. Morris:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You mav. 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 aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Creatine Kinase Device Name:

Indications For Use:

Veronica Dahluia for Jair Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K983070/51

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Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use_ Prescription Use / OR (Per 21 CFR 801.109)

(Optional Format 1-2-96)

Creatine Kinase 510(k) September 1, 1998 CK_5_VI.lwp

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.