(89 days)
VITROS® Troponin I ES Reagent Pack:
For in vitro diagnostic use only.
For the quantitative measurement of cardiac Troponin I (cTnI) in human serum and plasma (heparin and EDTA) using the VITROS Immunodiagnostic System, to aid in the assessment of myocardial damage and risk stratification.
Cardiac Troponin I measurement aids in the diagnosis of acute myocardial infarction and in the risk stratification of patients with non-ST-segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction (MI) or increased probability of ischemic events requiring urgent revascularization procedures.
VITROS® Troponin I ES Calibrators:
For in vitro diagnostic use only.
For use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of cardiac Troponin I (cTnI) in human serum and plasma (heparin and EDTA).
VITROS® Troponin I ES Range Verifiers:
For in vitro diagnostic use only.
For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the quantitative measurement of cardiac Troponin I (cTnI).
- The VITROS Immunodiagnostic Products range of immunoassav products: VITROS Immunodiagnostic Products Troponin I ES Reagent Pack, the VITROS Immunodiagnostic Products Troponin I ES Calibrators and the VITROS Immunodiagnostic Products Troponin I ES Range Verifiers, (which are combined by the VITROS Immunodiagnostic System to perform the VITROS Troponin I ES assay), and VITROS Immunodiagnostic Products High Sample Diluent B.
- The VITROS Immunodiagnostic System: Instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919).
- Common reagents used by the VITROS System in each assay: The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).
Note: High Sample Diluent B was cleared as part of the VITROS Immunodiagnostic Products Total ß-hCG Reagent Pack and VITROS Immunodiagnostic Products Total ß-hCG Calibrators 510(k) premarket notification (K970894).
The VITROS Immunodiagnostic System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.
This 510(k) summary describes the VITROS® Immunodiagnostic Products Troponin I ES Reagent Pack, Calibrators, and Range Verifiers, designed for the quantitative measurement of cardiac Troponin I (cTnI). The submission aims to demonstrate substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the new device are implied by a comparison to a predicate device (BECKMAN Access® AccuTnI Troponin I assay) and various clinical and analytical standards. The document primarily focuses on establishing "substantial equivalence" rather than specific numerical acceptance criteria for each performance characteristic. However, the listed "Differences" section in Table 1 can be interpreted as the reported device performance compared to specific characteristics of the predicate.
| Characteristic | Acceptance Criteria (Implied by Predicate/Standards) | Reported Device Performance (VITROS Troponin I ES) |
|---|---|---|
| Intended Use | Similar to predicate | For quantitative measurement of cTnI in human serum and plasma (heparin and EDTA) to aid in assessment of myocardial damage and risk stratification. Aids in diagnosis of acute MI and risk stratification of non-ST-segment elevation acute coronary syndromes. |
| Basic Principle | Chemiluminescence Immunoassay | Solid phase immunoassay (Note: Predicate is 2-site immunoenzymatic, both are chemiluminescence) |
| Tracer | Enzyme labeled | Enzyme labeled |
| Instrumentation | Automated Immunoassay System | Automated Immunoassay System |
| Antibody | Mouse monoclonal | Mouse monoclonal |
| Sample Type | Serum and plasma (heparin and EDTA) | Serum and plasma (heparin and EDTA) |
| Organizations Used/Referenced | NACB, ESC/ACC/AHA, WHO | NACB, ESC/ACC/AHA, WHO |
| Lower Limit of Detection | Generally acceptable sensitivity | 0.012 ng/mL (Note: Predicate "Not applicable" for this specific metric) |
| Sample Volume | Not explicitly defined as acceptance criteria for new device, but a comparative point of difference. | 80 µL |
| Measuring Range | Broad enough for clinical utility | 0.012-80.0 ng/mL |
| Analytical Sensitivity | Comparable to predicate | <0.009 ng/mL (Predicate: 0.01 ng/mL) |
| Hook Effect | None within clinical range | None up to 14,000 ng/mL (Predicate: None up to 1,920 ng/mL) |
| Expected Values: 99th percentile URL | Clinically appropriate (e.g., comparable to predicate) | 0.034 ng/mL (Predicate: 0.04 ng/mL) |
| AMI Cut off | Clinically appropriate sensitivity and specificity | 0.120 ng/mL (95% sens., 93% spec.) (Predicate: 0.50 ng/mL (96% sens., 94% spec.)) |
| 10% CV | Clinically acceptable precision | 0.034 ng/mL (Predicate: 0.06 ng/mL) |
| Spec. & Sens over time (0 to 24 hrs.) | Clinically acceptable performance over time | Sens. Range 69-90%, Spec. Range 94-96% (Predicate: Sens. Range 46-91%, Spec. Range 96-88%) |
| CLSI Standards Used/Referenced | Adherence to relevant standards | C24, EP5, EP6, EP7, EP9, EP17, C28, GP10, H3, H4, M29 (Predicate: EP6-P, EP5-A, EP7-P) |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary provides limited detail on the specific study design and sample sizes for performance evaluation. It lists several CLSI (Clinical and Laboratory Standards Institute) standards used or referenced (e.g., C24, EP5, EP6, EP7, EP9, EP17, C28, GP10, H3, H4, M29). These standards typically outline methods for determining analytical validity, including precision, accuracy, linearity, and sensitivity/specificity. However, the document does not explicitly state the sample sizes used for various test sets, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the 510(k) summary. Given that this is an in-vitro diagnostic device for measuring a biomarker, the "ground truth" would typically be established based on accepted clinical definitions of myocardial infarction and acute coronary syndromes, potentially involving cardiologist diagnoses, clinical outcomes, and the results from a predicate device or a reference method. The document does not mention the involvement of experts for ground truth establishment for the test set.
4. Adjudication Method for the Test Set
The 510(k) summary does not provide any information regarding an adjudication method for the test set. For an immunoassay, the "ground truth" is typically the measured concentration of the analyte, verified against established clinical cut-offs or comparative methods.
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
This section is not applicable as the device described is an in-vitro diagnostic immunoassay for quantitative measurement of Troponin I, not an AI-powered image analysis or diagnostic support tool for human readers. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is an in-vitro diagnostic assay for measuring a biomarker. The device itself (the immunoassay system) operates in a standalone manner to generate quantitative results. The performance metrics presented (analytical sensitivity, measuring range, hook effect, 99th percentile URL, AMI cut-off sensitivity/specificity, 10% CV) are inherent to the algorithm and chemical reactions of the assay and represent its standalone performance. The human "in-the-loop" aspect would be a clinician interpreting the numerical result in the context of a patient's overall clinical presentation.
7. The Type of Ground Truth Used
The ground truth for this device is based on several elements:
- Expert Consensus/Clinical Criteria: The "Indications for Use" explicitly state the device aids in the diagnosis of acute myocardial infarction and risk stratification based on established clinical understanding of cardiac Troponin I. The reference to organizations like NACB, ESC/ACC/AHA, and WHO further supports this.
- Comparison to Predicate Device: Substantial equivalence is established through direct comparison to the BECKMAN Access® AccuTnI Troponin I assay, implying that the predicate's established performance serves as a benchmark for the new device's ground truth and clinical utility.
- Analytical Performance Metrics: The analytical performance data (e.g., analytical sensitivity, measuring range, precision/CV, hook effect) are assessed against established laboratory and clinical standards (like CLSI guidelines), which serve as the "ground truth" for the device's technical specifications.
- AMI Cut-off/Sensitivity/Specificity: The reported AMI cut-off with associated sensitivity and specificity indicates that clinical diagnoses of AMI (presumably established through independent clinical criteria, though not detailed here) were used as a "ground truth" to determine the diagnostic performance of the assay.
8. The Sample Size for the Training Set
The 510(k) summary does not provide information about a specific "training set" size. For an immunoassay, the development process involves extensive analytical testing and optimization (which could be considered analogous to "training" in a broader sense), but these details are not typically disclosed as specific sample sizes for a 'training set' in the context of machine learning. The focus here is on the analytical and clinical validation studies demonstrating performance.
9. How the Ground Truth for the Training Set Was Established
As no specific "training set" is identified in the context of an AI/machine learning model, the establishment of ground truth for a training set is not applicable in the documented submission. The "ground truth" for the development and validation of the assay involves the iterative process of developing reagents and calibrators, testing their analytical performance against known standards and established clinical samples, and comparing results to predicate devices, adhering to industry guidelines (e.g., CLSI).
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510(k) Summary
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.
Ko 62838 The assigned 510(k) number is
Submitter Name, Address, Contact 1.
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 (585) 453-3730
Contact Person: Charlotte Baker
Preparation Date 2.
Date 510(k) prepared: September 20, 2006
3. Device Name
Trade or Proprietary Names: VITROS® Immunodiagnostic Products Troponin I ES Reagent Pack VITROS® Immunodiagnostic Products Troponin I ES Calibrators VITROS® Immunodiagnostic Products Troponin I ES Range Verifiers
Common Name: Troponin I assay and controls
Classification Names: Immunoassay Method, Troponin Subunit, (862.1215), Class II
Calibrator, multi-analyte mixture, (862.1150), Class II
Quality control material, (assayed and unassayed), (862.1660), Class I
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Predicate Device 4.
The VITROS® Immunodiagnostic Products Troponin I ES Reagent Pack and Calibrators (the VITROS Troponin I ES assay) are substantially equivalent to the BECKMAN Access® AccuTnI Troponin I assay (K974075).
The VITROS® Immunodiagnostic Products Troponin I ES Range Verifiers are substantially equivalent to the VITROS Troponin I Range Verifiers (K992349).
ક. Device Description
-
- The VITROS Immunodiagnostic Products range of immunoassav products: VITROS Immunodiagnostic Products Troponin I ES Reagent Pack, the VITROS Immunodiagnostic Products Troponin I ES Calibrators and the VITROS Immunodiagnostic Products Troponin I ES Range Verifiers, (which are combined by the VITROS Immunodiagnostic System to perform the VITROS Troponin I ES assay), and VITROS Immunodiagnostic Products High Sample Diluent B.
-
- The VITROS Immunodiagnostic System: Instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919).
-
- Common reagents used by the VITROS System in each assay: The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).
Note: High Sample Diluent B was cleared as part of the VITROS Immunodiagnostic Products Total ß-hCG Reagent Pack and VITROS Immunodiagnostic Products Total ß-hCG Calibrators 510(k) premarket notification (K970894).
The VITROS Immunodiagnostic System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.
Ortho-Clinical Diagnostics, Inc.
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Device Intended Use 6.
VITROS Troponin I ES Reagent Pack:
For in vitro diagnostic use only.
For the quantitative measurement of cardiac Troponin I (cTnI) in human serum and plasma (heparin and EDTA) using the VITROS Immunodiagnostic System, to aid in the assessment of myocardial damage and risk stratification.
Cardiac Troponin I measurement aids in the diagnosis of acute myocardial infarction and in the risk stratification of patients with non-ST-segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction (MI) or increased probability of ischemic events requiring urgent revascularization procedures.
VITROS Troponin I ES Calibrators:
For in vitro diagnostic use only.
For use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of cardiac Troponin I (cTnI) in human serum and plasma (heparin and EDTA).
VITROS Troponin I ES Range Verifiers:
For in vitro diagnostic use only.
For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the quantitative measurement of cardiac Troponin I (cTnI).
7. Comparison to Predicate Device
The VITROS® Immunodiagnostic Products Troponin I ES Reagent Pack and Calibrators are substantially equivalent to the BECKMAN Access® AccuTnI Troponin I Reagent Pack and Calibrators (K974075).
The VITROS® Immunodiagnostic Products Troponin I ES Range Verifiers are substantially equivalent to the VITROS Troponin I Range Verifiers (K992349).
Table 1 (page 4) presents the similarities and differences of both assays.
Table 2 (page 5) presents the similarities and differences of both calibrators
Table 3 (page 5) presents the similarities and differences of both range verifiers.
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| Similarities | ||
|---|---|---|
| DeviceCharacteristic | New Device-VITROS® Troponin I ESassay | Predicate Device-BECKMAN Access®AccuTnI Troponin I assay |
| Intended Use | For the in vitro quantitative measurement ofcardiac Troponin I (cTnI) in human serumand plasma (heparin and EDTA) using theVITROS Immunodiagnostic System, to aid inthe assessment of myocardial damage andrisk stratification. | For the in vitro quantitative determinationof cardiac troponin I (cTnI) levels inhuman serum and plasma using theAccess Immunoassay Systems to aid inthe diagnosis and treatment ofmyocardial infarction and cardiac muscledamage. |
| Cardiac Troponin I measurement aids in thediagnosis of acute myocardial infarction andin the risk stratification of patients with non-ST-segment elevation acute coronarysyndromes with respect to relative risk ofmortality, myocardial infarction (MI) orincreased probability of ischemic eventsrequiring urgent revascularization procedures. | Cardiac troponin I determination aids inthe risk stratification of patients withunstable angina or non-ST segmentelevation acute coronary syndromes withrespect to relative risk of mortality,myocardial infarction, or increasedprobability of ischemic events requiringurgent revascularization procedures. | |
| Basic Principal | Chemiluminescence Immunoassay | Chemiluminescence Immunoassay |
| Tracer | Enzyme labeled | Enzyme labeled |
| Instrumentation | Automated Immunoassay System | Automated Immunoassay System |
| Antibody | Mouse monoclonal | Mouse monoclonal |
| Sample type | Serum and plasma (heparin and EDTA) | Serum and plasma (EDTA and heparin) |
| Organizationsused/referenced | NACB, ESC/ACC/AHA, WHO | NACB, ESC/ACC/AHA, WHO |
| Lower Limit ofDetection | 0.012ng/mL | Not applicable |
| Differences | ||
| Basic principle | Solid phase immunoassay | 2-site immunoenzymatic assay |
| Sample volume | 80µL | 40µL |
| Measuring range | 0.012-80.0 ng/mL | 0.01-100 ng/mL |
| Analytical Sensitivity | <0.009 ng/mL | 0.01 ng/mL |
| Hook Effect | None up to 14,000 ng/mL | None up to 1,920 ng/mL |
| Expected Values: 99thpercentile URL | 0.034 ng/mL | 0.04 ng/mL |
| AMI Cut off | 0.120 ng/mL (95% sens., 93% spec.) | 0.50 ng/mL (96% sens., 94% spec.) |
| 10% CV | 0.034 ng/mL | 0.06 ng/mL |
| Spec.& Sens over time(0 to 24 hrs.) | Sens. Range 69-90%Spec. Range 94-96% | Sens. Range 46-91%Spec. Range 96-88% |
| CLSI Standards Used orReferenced | C24, EP5, EP6, EP7, EP9, EP17, C28,GP10, H3, H4, M29 | EP6-P, EP5-A, EP7-P |
Comparison of the VITROS and BECKMAN Troponin I assays Table 1
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Table 2 Comparison of the VITROS and BECKMAN Troponin I Calibrators
| Similarities | ||
|---|---|---|
| DeviceCharacteristic | New Device-VITROS® Troponin IES Calibrators | Predicate Device-BECKMAN Access®AccuTnI Troponin I Calibrators |
| Intended Use | For use in the calibration of theVITROS Immunodiagnostic System forthe quantitative measurement of cardiacTroponin I (cTnI) in human serum andplasma (heparin and EDTA). | Intended to calibrate the Access AccuTnI assayfor the quantitative determination of cardiactroponin I (cTnI) levels in human serum andplasma using the Access Immunoassay Systemsto aid in the diagnosis and treatment ofmyocardial infarction and cardiac muscledamage. |
| CalibratorFormat | Liquid | Liquid |
| Differences | ||
| CalibratorLevels | 3 | 6 |
| Table 3 Comparison of the VITROS Troponin I Range Verifiers | |||
|---|---|---|---|
| Similarities | |||
|---|---|---|---|
| DeviceCharacteristic | New Device-VITROS® Troponin I ESRange Verifiers | Predicate Device-VITROS® Troponin IRange Verifiers | |
| Intended Use | For in vitro us in verifying the calibrationrange of the VITROS ImmunodiagnosticSystem when used for the measurement ofcardiac Troponin I (cTnI). | For in vitro us in verifying the calibrationrange of the VITROS ImmunodiagnosticSystem when used for the measurement ofcardiac Troponin I (cTnI). | |
| Matrix of RangeVerifiers | Human serum based matrix withantimicrobial agent | Human serum based matrix with bovineproteins and antimicrobial agent | |
| Differences | |||
| Range VerifierLevels | Low and High (0 & 80 ng/mL) | Low and High (0 & 95 ng/mL) | |
| Format | Liquid | Freeze-dried |
8. Conclusions
The data presented provide a reasonable assurance that the VITROS Immunodiagnostic Products Troponin I ES Reagent Pack, Calibrators and Range Verifiers are safe and effective for the stated intended uses and are substantially equivalent to the predicate devices.
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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem of an eagle with outstretched wings, stylized with three thick, curved lines representing the wings and body.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Charlotte Baker Regulatory Affairs Specialist Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Dr. Rochester, NY 14626-5101
DEC 1 9 2006
Re: K062838
Trade/Device Name: VITROS Immunodiagnostic Products Troponin I ES Reagent Pack VITROS Immunodiagnostic Products Troponin I ES Calibrator VITROS Immunodiagnostic Products Troponin I ES Range Verifier
Regulation Number: 21 CFR§ 862.1215
21 CFR§ 862.1150 21 CFR8 862.1660
Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: MMI, JIT, JJX Dated: September 21, 2006 Received: September 26, 2006
Dear Ms. Baker:
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. Iisting 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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours.
Alberto Gutierrez
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Statement of Intended Use
| 510(k) Number (if known): | < 0 6 2838 | ||
|---|---|---|---|
| Device Names: | VITROS® Immunodiagnostic Products Troponin I ES Reagent PackVITROS® Immunodiagnostic Products Troponin I ES CalibratorsVITROS® Immunodiagnostic Products Troponin I ES Range Verifiers | ||
| Indications for Use: | VITROS® Troponin I ES Reagent Pack:For in vitro diagnostic use only.For the quantitative measurement of cardiac Troponin I (cTnI) in humanserum and plasma (heparin and EDTA) using the VITROS ImmunodiagnosticSystem, to aid in the assessment of myocardial damage and risk stratification. | ||
| Cardiac Troponin I measurement aids in the diagnosis of acute myocardialinfarction and in the risk stratification of patients with non-ST-segmentelevation acute coronary syndromes with respect to relative risk of mortality,myocardial infarction (MI) or increased probability of ischemic eventsrequiring urgent revascularization procedures. | |||
| VITROS® Troponin I ES Calibrators:For in vitro diagnostic use only.For use in the calibration of the VITROS Immunodiagnostic System for thequantitative measurement of cardiac Troponin I (cTnI) in human serum andplasma (heparin and EDTA). | |||
| VITROS® Troponin I ES Range Verifiers:For in vitro diagnostic use only.For in vitro use in verifying the calibration range of the VITROSImmunodiagnostic System when used for the quantitative measurement ofcardiac Troponin I (cTnI). | |||
| 1Prescription Use(Part 21 CFR 801 Subpart D) | Over-The-Counter UseAND/OR(21 CFR 801 Subpart C) | ||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OFNEEDED) | |||
| Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OMD) | |||
| ign- |
Ortho-Clinical Diagnostics, Inc.
Office of In Vitro Diagnostic Device
Evaluation and Safety
September 20 , 2006
§ 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.