IMMULITE® Turbo CK-MB is a two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) antigen in serum or heparinized plasma. It is intended strictly for in vitro use as an aid in patient management and the assessment of prognosis of myocardial infarction.

Device Description

IMMULITE® Turbo CK-MB is a clinical device for use with the IMMULITE® Automated Immunoassay Analyzer.

AI/ML Overview

The provided text is a 510(k) summary for the IMMULITE® Turbo CK-MB device. It details the device's intended use and the regulatory process, but it does not contain specific information about detailed acceptance criteria or a dedicated study proving the device meets those criteria, as one would expect for an AI/ML medical device submission.

This document is from 1999 and pertains to an immunoassay for measuring CK-MB, which is a laboratory diagnostic. At that time, the regulatory requirements and types of studies for such devices were different from those for AI/ML-based diagnostic devices. The summary focuses on establishing "substantial equivalence" to a predicate device, which is a common pathway for traditional IVDs.

Therefore, many of the requested details, particularly those related to a "device" in the context of AI/ML performance, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, and standalone performance for AI, are not applicable or available in this document.

However, I can extract the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state acceptance criteria in the format of a typical AI/ML study (e.g., minimum sensitivity, specificity, or AUC). Instead, for an immunoassay, the "performance" is demonstrated through its ability to accurately measure CK-MB antigen, and the overall conclusion is that the data presented allowed the FDA to grant "substantial equivalence." This implies that the performance was deemed acceptable in comparison to a predicate device, likely based on analytical performance data (precision, accuracy, linearity, etc.) which is not detailed in this summary document but would have been part of the full 510(k) submission.

Therefore, a table cannot be constructed with explicit acceptance criteria and corresponding reported performance metrics in the AI/ML sense. The conclusion of the document is: "The data presented in this summary of safety and effectiveness is the data that the Food and Drug Administration used in granting DPC substantial equivalence for IMMULITE® Turbo CK-MB." This serves as the overarching "reported device performance" against the implicit "acceptance criteria" for substantial equivalence.

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

Sample size for test set: Not explicitly stated in this 510(k) summary. The summary refers to "data presented," but does not break down the clinical study or test set sizes.
Data provenance: Not explicitly stated. For an IVD from this era, it would likely involve clinical samples collected from a relevant patient population, but the country of origin or whether it was retrospective/prospective is not mentioned in this summary.

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

This concept of "experts establishing ground truth" is not directly applicable to a quantitative immunoassay like IMMULITE® Turbo CK-MB in the same way it applies to diagnostic imaging or AI interpretation. The "ground truth" for an immunoassay is typically the actual concentration of the analyte (CK-MB) in the sample, determined by a reference method or validated analytical techniques (which would be used for method comparison studies).
No information about experts establishing ground truth is provided.

4. Adjudication method for the test set:

Not applicable as there is no "adjudication" in the context of expert review for this type of quantitative immunoassay.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a standalone laboratory immunoassay analyzer, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data with and without AI assistance.

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

Yes, in concept. The IMMULITE® Turbo CK-MB is a standalone analytical device (an automated immunoassay analyzer) that measures CK-MB levels. Its "performance" is its ability to accurately and precisely quantify CK-MB antigen in serum or plasma, independent of human interpretation beyond pipetting and result reporting. This summary, however, does not detail the analytical performance study results (e.g., precision, accuracy, linearity studies) that would demonstrate this standalone performance.

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

The "ground truth" for a quantitative immunoassay like this would be the true concentration of the analyte (CK-MB) in the patient samples. This is typically established using a highly accurate and precise reference method or a thoroughly validated comparative method.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a "training set" in the computational sense. The device is a reagent system and an automated analyzer. Its development involves chemical and biological optimization, calibration, and analytical validation rather than machine learning training.

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

Not applicable. See point 8.

Summary

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JUN 9 1999

K991797

510(k) Summary Safety and Effectiveness

This summary of safety and effectiveness information has been prepared in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.

Name:	Diagnostic Products Corporation
Address:	5700 West 96th StreetLos Angeles, California 90045-5597
Telephone Number:	(310) 645-8200
Facsimile Number:	(310) 645-9999
Contact Person:	Edward M. Levine, Ph.D.Director of Clinical Affairs
Date of Preparation:	May 25, 1999
Device Name:Trade:	IMMULITE® Turbo CK-MB
Catalog Number:	LSKCP1 (100 tests), LSKCP5 (500 tests)
Common:	Reagent system for the determination of creatine kinaseisoenzyme MB (CK-MB) in serum or heparinized plasma.
Classification:	Class II device, 75-JHX (21 CFR 862.1215)
Manufacturer:	Diagnostic Products Corporation5700 West 96th StreetLos Angeles, California 90045-5597
Sole U.S. Importer:	Diagnostic Products Corporation5700 West 96th StreetLos Angeles, California 90045-5597
Establishment RegistrationNumber	DPC's Registration Number is 2017183
Description of Device:	IMMULITE® Turbo CK-MB is a clinical device for usewith the IMMULITE® Automated Immunoassay Analyzer.

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K991797

Intended Use of the Device:

Conclusion:

The data presented in this summary of safety and effectiveness is the data that the Food and Drug Administration used in granting DPC substantial equivalence for IMMULITE® Turbo CK-MB.

Edward L. Schein

Edward M. Levine, Ph.D. Director of Clinical Affairs

1/25/55
Date

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized birds in flight. The birds are arranged in a row, with the first bird being the largest and the third bird being the smallest.

9 1999 JUN

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Edward M. Levine, Ph.D. Director of Clinical Affairs Diagnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045-5597

Re: K991797 Trade Name: Immulite Turbo CK-MB Regulatory Class: II Product Code: JHX Dated: May 25, 1999 Received: May 26, 1999

Dear Dr. Levine:

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 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. 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 OS 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 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.

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

Sincerely yours,

Steven Putman

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): Device Name: IMMULITE® Turbo CK-MB

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-

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.