The Creatine Kinase assay is used for the quantitation of creatine kinase in human 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.

Device Description

Creatine Kinase (CK) is an in vitro diagnostic assay for the quantitative determination of creatine kinase activity in human serum. The Creatine Kinase assay is a clinical chemistry assay in which creatine kinase 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 NAD to NADH. The rate of formation of NADH is monitored at 340 nm and is proportional to the activity of CK in the sample. This reagent also contains AMP and di-(adenosine-5')-pentaphoshate to prevent interference from adenylate kinase.

AI/ML Overview

The Abbott Laboratories Creatine Kinase assay is an in vitro diagnostic device for the quantitative determination of creatine kinase activity in human serum. This 510(k) summary (K981218) submitted in 1998 demonstrates its substantial equivalence to the Roche Cobas Mira Plus Automated Chemistry System CK NAC assay.

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Characteristic	Acceptance Criteria (Implied by Predicate)	Reported Device Performance
Correlation Coefficient (with predicate)	High correlation (e.g., >0.95)	0.9972
Slope (vs. predicate)	Near 1.0 (indicating proportional agreement)	1.007
Y-intercept (vs. predicate)	Near 0.0 (indicating minimal constant bias)	-8.757 U/L
Total %CV (Precision - Level 1)	Low variability	2.6%
Total %CV (Precision - Level 2)	Low variability	2.3%
Linearity/Assay Range	Comparable to predicate	Up to 2,100 U/L
Limit of Quantitation (Sensitivity)	Comparable to predicate	12 U/L

Note: The acceptance criteria are "implied by the predicate" as explicit thresholds are not provided in the summary. Substantial equivalence is claimed based on the similarity of performance characteristics to the already marketed predicate device.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the specific sample size used for the comparative performance studies or precision studies. It simply mentions that "comparative performance studies were conducted" and "precision studies were conducted." The data provenance (country of origin, retrospective or prospective) is also not specified, which is common for older 510(k) submissions focusing on in vitro diagnostics. However, given it's a clinical chemistry assay, the samples would likely be human serum.

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

Not applicable. For in vitro diagnostic assays like this, "ground truth" for the test set is established by comparative measurements against a well-established and legally marketed predicate device (the Roche Cobas Mira Plus Automated Chemistry System CK NAC assay) using clinical samples. It does not involve human expert adjudication in the same way an imaging or diagnostic AI device would. The performance of the predicate device serves as the reference standard.

4. Adjudication Method for the Test Set:

Not applicable. As described above, the ground truth is established by the predicate device's measurements, not human 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:

Not applicable. This is an in vitro diagnostic assay and does not involve human readers interpreting results in a way that would necessitate an MRMC study or an assessment of AI assistance for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, the studies describe the standalone performance of the Creatine Kinase assay. The stated performance characteristics (correlation, precision, linearity, sensitivity) are inherent to the device itself when processing samples.

7. The Type of Ground Truth Used:

The ground truth for evaluating the Creatine Kinase assay's performance was the measurements obtained from the legally marketed predicate device, the Roche Cobas Mira Plus Automated Chemistry System CK NAC assay. This is a common approach for demonstrating substantial equivalence for in vitro diagnostics, where a new device's accuracy and reliability are compared to an already accepted method.

8. The Sample Size for the Training Set:

Not applicable. This device is a traditional in vitro diagnostic assay, not an AI/ML-based device that requires a training set in the conventional sense. The "training" for such devices involves reagent formulation, instrument calibration, and optimization based on chemical principles and standard analytical practices, typically using reference materials and established methods rather than large datasets of clinical "training" data.

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

Not applicable, as there is no training set in the context of AI/ML. The "ground truth" for developing and calibrating such a device would be based on:

Known concentrations/activities: Using certified reference materials or highly characterized samples with known CK activity.
Reference methods: Comparing results to established, gold-standard laboratory methods (though the predicate device is used for substantial equivalence, not necessarily the primary "ground truth" for initial development).
Analytical specifications: Ensuring the chemical reactions and detection mechanisms perform according to established scientific principles and expected analytical performance ranges.

Summary

{0}------------------------------------------------

KG81218

MAY 1 1998 510(k) Summary

Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038

Contact Person Mark Littlefield Section Manager MS 1-8 Regulatory Affairs (972) 518-7861 Fax (972) 753-3367

Date of Preparation of this Summary:	April 02, 1998
Device Trade or Proprietary Name:	CK
Device Common/Usual Name or Classification Name:	Creatine Kinase
Classification Number/Class:	75CGS/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) April 2, 1998 CkfE2.lwp

Section II Page 1

Image /page/0/Picture/11 description: The image shows a sequence of numbers. The sequence is composed of zeros and ones. Specifically, the sequence is "0000011".

{1}------------------------------------------------

Substantial Equivalence:

The Creatine Kinase assay is substantially equivalent to the Roche® Cobas Mira® Plus Automated Chemistry System CK NAC assay (K834502).

Both assays yield similar Performance Characteristics.

Similarities:

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

Differences:

There is a minor difference between the assay range. .

Intended Use:

The Creatine Kinase assay is used for the quantitation of creatine kinase in human serum.

Performance Characteristics:

Comparative performance studies were conducted using the ALCYON™ Analyzer. The Creatine Kinase assay method comparison yielded acceptable correlation with the Roche Cobas Mira Plus Automated Chemistry System CK NAC assay. The correlation coefficient = 0.9972. slope = 1.007, and Y-intercept = - 8.757 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 111 is 2.6% and 2.3% for Level 2/ Panel 112. The Creatine Kinase assay is linear up to 2,100 U/L. The limit of quantitation (sensitivity) for the Creatine Kinase assay is 12 U/L. These data demonstrate that the performance of the Creatine Kinase assay is substantially equivalent to the performance of the Roche Cobas Mira Plus Automated Chemistry System CK NAC assay.

Creatine Kinase 510(k) April 2, 1998 CkfE2.lwp

Section II Page 2

Image /page/1/Picture/15 description: The image shows the number 0000012. The number is written in a bold, sans-serif font. The numbers are all the same size and are evenly spaced. The number is black and the background is white.

{2}------------------------------------------------

Conclusion:

The Creatine Kinase assay is substantially equivalent to the Roche Cobas Mira Plus Automated Chemistry System CK NAC assay as demonstrated by results obtained in the studies.

Creatine Kinase 510(k) April 2, 1998
CkfE2.lwp

Section II Page 3

Image /page/2/Picture/4 description: The image shows a sequence of numbers, specifically "0000013". The number is written in a bold, sans-serif font. The numbers are all the same size and are evenly spaced.

{3}------------------------------------------------

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

1 1998 MAY

Mark Littlefield . Section Manager, Regulatory Affairs Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038

K981218 Re: Creatine Kinase Regulatory Class: II ପ୍ରତିଶତ Product Code: Dated: April 2, 1998 Received: April 3, 1998

Dear Mr. Littlefield:

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 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 may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੈ 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 regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. 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 regulations.

{4}------------------------------------------------

Page 2

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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Litman

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

{5}------------------------------------------------

K991218 510(k) Number (if known): __

Creatine Kinase Device Name:

Indications For Use:

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number.
KC984218

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

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)

00000000

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.