CREATINE KINASE (CK)

• K Number: K972155
• Device Name: CREATINE KINASE (CK)
• Manufacturer: STANBIO LABORATORY
• Date Cleared: 1997-07-17 ( 42 days)
• Product Code: CGS
• Regulation Number: 862.1215
• Type: Traditional
• Panel: Clinical Chemistry
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Stanbio Laboratory's Creatine Kinase (CK) Liqui-UV 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 serum. Serum creatine kinase (CK) levels have proven valuable in the assessment of cardiac and skeletal muscle diseases, including myocardial infarction and muscular dystrophy.

Device Description

The device test kit is comprised of two reagents, CK Buffer (R1) and CK Enzyme (R2). A working reagent is prepared by combining five parts CK Buffer (R1) to one part CK Enzyme (R2).

AI/ML Overview

Here's an analysis of the provided text regarding the Creatine Kinase (CK) Liqui-UV device, focusing on acceptance criteria and supporting studies:

This document is a 510(k) summary for a clinical laboratory device, specifically an in-vitro diagnostic (IVD) test kit. The information provided is primarily for demonstrating substantial equivalence to a predicate device rather than a comprehensive performance study for a novel medical AI device. Therefore, many of the requested categories (e.g., number of experts for ground truth, adjudication methods, MRMC studies, training set details) are not applicable or not provided in the context of an IVD submission of this nature.

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Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implied/Stated)	Reported Device Performance
Method Comparison (Substantial Equivalence)	Correlation coefficient indicating strong agreement with predicate device. Linear regression showing proportional bias and intercept close to zero.	Correlation Coefficient: 0.999 (with Boehringer Mannheim CK/NAC) Regression Equation: y = 1.027x - 0.65
Precision	Acceptable variability/reproducibility of results.	"Results of these tests were found to be acceptable." (No specific metrics provided in the summary)
Linearity	Acceptable performance across a range of analyte concentrations.	"Results of these tests were found to be acceptable." (No specific metrics provided in the summary)
Sensitivity	Ability to detect low levels of the analyte.	"Results of these tests were found to be acceptable." (No specific metrics provided in the summary)
Stability	Acceptable performance over time under specified conditions.	"Results of these tests were found to be acceptable." (No specific metrics provided in the summary)
Interference	Acceptable performance in the presence of common interfering substances.	"Results of these tests were found to be acceptable." (No specific metrics provided in the summary)

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Study Details

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

   • The document does not specify the sample size used for the method comparison or other performance studies.
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, for IVD studies of this type, it's typically a controlled laboratory study using patient samples or spiked samples. It's prospective in the sense that the study was conducted specifically for this submission.

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

   • Not applicable in the context of this IVD device. The "ground truth" for method comparison is the measurement obtained from the predicate device (Boehringer Mannheim CK/NAC). The performance of the predicate device itself would have been established through its own validation studies. This isn't an image-based AI device requiring expert adjudication.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. There's no expert adjudication process described for establishing ground truth for an IVD test's quantitative results.

4. 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 test kit that directly measures a biochemical marker, not an AI-assisted diagnostic imaging or interpretation tool that involves human "readers."

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

   • This device is a "standalone" laboratory test in the sense that its performance is evaluated independent of a human's interpretive input beyond running the assay and reading the result. Its assessment is purely on its analytical performance (accuracy, precision, etc.) in a laboratory setting. There is no "algorithm" in the AI sense for this type of chemical assay.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for demonstrating substantial equivalence and analytical performance is the results obtained from the legally marketed predicate device (Boehringer Mannheim CK/NAC) for method comparison. For other studies like linearity and precision, the "ground truth" is typically established by reference materials, known analyte concentrations, or statistical measures against repeated measurements.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that requires a training set.

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

   • Not applicable. As above, there is no training set for this type of IVD device.

Summary

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K972155

JUL 17 1997

510(k) SUMMARY

Submitter's Name Kirk Johnson Stanbio Laboratory, Inc. 2930 East Houston Street San Antonio, TX 78202

Tel. [phone] Fax [phone]

Prepared By Kirk Johnson May 30, 1997

Product Name Trade name: Creatine Kinase (CK) Liqui-UV® Common name: Creatine Kinase (CK) Classification name: N-Acetyl-L-Cysteine, Creatine Kinase Class II, 75JFX

Substantial Equivalence of Device This test is substantially equivalent to : Product Name: CK/NAC Manufacturer Boehringer Mannheim

Description of Device

The device test kit is comprised of two reagents, CK Buffer (R1) and CK Enzyme (R2). A working reagent is prepared by combining five parts CK Buffer (R1) to one part CK Enzyme (R2).

Intended Use of Device The device is used for the kinetic quantitative determination of Creatine Kinase (CK) in serum.

Comparison of Devices

Both Creatine Kinase (CK) methods measure kinetically the rate of NADPH formation at a rate proportional to the CK activity.

Performance Data

Substantial equivalency was demonstrated by method comparison. Correlation was performed between the two test kits with a correlation coefficient of 0.999 and a regression equation of y = 1.027x - 0.65.

In addition, precision, linearity, sensitivity, stability and interference studies were performed on Stanbio Laboratory, Inc., version of Creatine Kinase (CK) Liqui-UV®. Catalog # 2910. Results of these tests were found to be acceptable.

LABORATORY, INC

http://www.stanbio.com

$\frac{CH}{II}$

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 1 7 1997

Kirk Johnson FDA Correspondent Stanbio Laboratory, Inc. 2930 E. Houston Street San Antonio, Texas 78202

Re: K972155 Creatine Kinase (CK) Liqui-UV® Requlatory Class: II Product Code: CGS Dated: May 30, 1997 Received: June 5, 1997

Dear Mr. Johnson:

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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 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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Paqe 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 [phone].

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] 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

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510(k) Number (if known):_K972155

Device Name: Creatine Kinase (CK) Liqui-UV

Indications For Use:

Stanbio Laboratory's Creatine Kinase (CK) Liqui-UV 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 serum. Serum creatine kinase (CK) levels have proven valuable in the assessment of cardiac and skeletal muscle diseases, including myocardial infarction and muscular dystrophy.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use V (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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.