The IMMULITE Turbo CK-MB is for in vitro diagnostic use with the IMMULITE Analyzer – for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in serum or heparinized plasma, as an aid in patient management and the assessment of prognosis of myocardial infarction.

Device Description

IMMULITE Turbo CK-MB is a solid-phase, two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the IMMULITE® Turbo CK-MB device, based on the provided text:

Based on the provided document, the device is the IMMULITE® Turbo CK-MB, a diagnostic assay for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in serum or heparinized plasma, intended as an aid in patient management and the assessment of prognosis of myocardial infarction.

Unfortunately, the provided 510(k) summary does not contain explicit acceptance criteria or details of a specific study proving the device meets those criteria. The document focuses on establishing substantial equivalence to a predicate device and describing the technology. It mentions "data presented in this summary of safety and effectiveness is the data that the Food and Drug Administration used in granting DPC substantial equivalence," but it does not present that data.

Therefore, many of the requested details cannot be extracted from this document alone.

Here's what can be inferred or directly stated from the provided text:

A table of acceptance criteria and the reported device performance

This information is not provided in the document. The document primarily describes the device, its intended use, and its technology, and then states that it has been found substantially equivalent to a predicate device (IMMULITE CK-MB, K004002). Typically, detailed performance data, including acceptance criteria, would be in a separate, more comprehensive study report or a different section of the 510(k) submission.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document.
Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.
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 an in vitro diagnostic (IVD) assay, not an imaging device typically involving human "readers" in the context of MRMC studies as understood for AI-powered image analysis. Therefore, an MRMC study as described (human readers improving with AI assistance) is not applicable to this type of device and is not mentioned or implied.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is an in vitro diagnostic (IVD) assay, which by its nature is a standalone test performed by an automated analyzer. The "algorithm only" concept applies as the device's performance is determined by the chemical reaction and light output measurement, not by human interpretation or intervention in the direct result calculation. The document describes the technical process of the assay, stating: "The bound complex - and thus also the photon output, as measured by the luminometer - is proportional to the concentration of CK-MB in the sample." This indicates a standalone, automated measurement.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For an IVD assay measuring CK-MB, the "ground truth" would typically be established by comparison to a recognized gold standard method for CK-MB quantification (e.g., a reference method, another validated commercial assay, or clinical correlation with myocardial infarction diagnosis based on clinical signs, symptoms, ECG changes, and other biomarker levels). However, the specific type of ground truth used for performance evaluation is not explicitly stated in this summary.
The sample size for the training set

This information is not provided in the document as it focuses on clinical validation, not machine learning model training.
How the ground truth for the training set was established

This information is not provided in the document, as it focuses on clinical validation, not machine learning model training.

Summary of what is known from the document regarding a "study":

The document states: "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 implies that a study or set of studies was conducted and reviewed by the FDA, but the details of those studies (sample sizes, methodologies, specific performance metrics, and acceptance criteria) are not included in this 510(k) summary. The summary is intended to provide an overview and demonstrate substantial equivalence, not to detail the full scientific evidence.

Summary

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JUL 2 2 2002

510(k) Summary of 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:Facsimile Number:	(310) 645-8200(310) 645-9999
Contact Person:	Edward M. Levine, Ph.D.Director, Clinical Affairs
Date of Preparation:	June 28, 2002
Device Name:Trade:	IMMULITE® Turbo CK-MB
Catalog Number:	LSKCP1 (100 tests), LSKCP5 (500 tests)
CFR:	A creatine phosphokinase/creatine kinase or isoenzymestest system is a device intended to measure the activity ofthe enzyme creatine phosphokinase or its isoenzymes (agroup of enzymes with similar biological activity) inplasma and serum. Measurements of creatinephosphokinase and its isoenzymes are used in the diagnosisand treatment of myocardial infarction and muscle diseasessuch as progressive, Duchenne-type muscular dystrophy.
Common:	Reagent system for the determination of creatine kinaseisoenzyme MB (CK-MB) in serum or heparinized plasma.
Classification:	Class II device, JHX (21CFR 862.1215)
Panel:	Clinical Chemistry
CLIA ComplexityCategory:	We believe the category to be moderate, based on previousclassification of analogous tests.
Manufacturer:	Diagnostic Products Corporation5700 West 96th StreetLos Angeles, California 90045-5597
Establishment RegistrationNumber:	DPC's Registration Number is 2017183

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Substantially Equivalent Predicate Device:

IMMULITE CK-MB (K004002)

Description of Device:

IMMULITE Turbo CK-MB is a solid-phase, two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer.

Intended Use of the Device:

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

Technology:

IMMULITE Turbo CK-MB is a solid-phase, two-site chemiluminescent immunometric assay. based on ligand-labeled monoclonal antibody and separation by anti-ligand-coated solid phase.

The patient sample, a ligand-labeled anti-CK-MB monoclonal antibody and an alkaline phosphatase-labeled anti-CK-BB monoclonal antibody are simultaneously introduced into the Test Unit containing immobilized anti-ligand, and incubated for approximately 6 minutes at 37°C with intermittent agitation. During this time, CK-MB in the sample forms an antibody sandwich complex which. in turn, binds to anti-ligand on the solid phase. Unbound conjugate is removed by a centrifugal wash; substrate is then added and the Test Unit is incubated for a further 10 minutes.

The chemiluminescent substrate, a phosphate ester of adamantyl dioxetane, undergoes bydrolysis in the presence of alkaline phosphatase to yield an unstable intermediate. The continuous production of this intermediate results in the sustained emission of light, thus improving precision by providing a window for multiple readings. The bound complex - and thus also the photon output, as measured by the luminometer - is proportional to the concentration of CK-MB in the sample.

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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three overlapping profiles, resembling an abstract bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the figure.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 2 2 2002

Edward M. Levine, Ph.D. Director of Clinical Affairs Diagnostic Products Corporation 5700 West 96ht Street Los Angeles, CA 90045

Re: K022118

Trade/Device Name: IMMULITE® Turbo CK-MB Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: JHX Dated: June 28, 2002 Received: July 1, 2002

Dear Dr. Levine:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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,

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): KO22-118 IMMULITE® Turbo CK-MB Device Name:

Indications For Use: The IMMULITE Turbo CK-MB is for in vitro diagnostic use with the IMMULITE Analyzer – for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in serum or heparinized plasma, as an aid in patient management and the assessment of prognosis of myocardial infarction.

(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)

Over-The-Counter Use

(Optional Format 1-2-96)

Congen
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K022118

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.