(22 days)
The IMMULITE 2500 CK-MB is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction.
The IMMULITE 2500 Myoglobin is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of myoglobin in serum and heparinized plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).
The IMMULITE 2500 STAT Troponin I is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).
IMMULITE 2500 CK-MB is a solid-phase, two-site IMMULITE chemiluminescent enzyme immunoassay for use with the IMMULITE 2500 Automated Analyzer.
IMMULITE 2500 Myoglobin is a solid-phase, two-site chemiluminescent enzyme immunoassay for use with the IMMULITE 2500 Automated Analyzer.
IMMULITE 2500 STAT Troponin I is a solid-phase, two-site chemiluminescent enzyme immunoassay for use with the IMMULITE 2500 Automated Analyzer.
Please note that the provided text describes an in vitro diagnostic (IVD) device, which measures biomarkers in patient samples. Such devices are evaluated based on analytical performance criteria (e.g., accuracy, precision, linearity, limits of detection) rather than clinical performance criteria like those for AI/ML-driven diagnostic aids. Therefore, many of the requested fields (multi-reader multi-case studies, expert adjudication, ground truth definition for training sets, effect size of human readers improving with AI) are not applicable to this type of device and will be marked as "N/A".
Here's an analysis of the provided text based on your request:
Device Name: IMMULITE® 2500 CK-MB, IMMULITE® 2500 Myoglobin, IMMULITE® 2500 STAT Troponin I
Device Type: In vitro diagnostic (IVD) chemiluminescent enzyme immunoassays for the quantitative measurement of cardiac biomarkers.
Intended Use:
- IMMULITE 2500 CK-MB: Quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction.
- IMMULITE 2500 Myoglobin: Quantitative measurement of myoglobin in serum and heparinized plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).
- IMMULITE 2500 STAT Troponin I: Quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).
1. Table of Acceptance Criteria and the Reported Device Performance
The provided 510(k) summary documents typically focus on demonstrating substantial equivalence to a predicate device based on similar intended use and technological characteristics, and often summarize the analytical performance data without listing specific pre-defined acceptance criteria values alongside achieved performance. The document states that "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." This implies that the presented data met the FDA's requirements for substantial equivalence, which would include acceptable analytical performance.
However, specific quantitative acceptance criteria (e.g., "bias must be less than X%", "CV must be less than Y%") are not explicitly stated in this summary document. The document refers to the data being sufficient for FDA clearance rather than providing a detailed breakdown of acceptance criteria and performance against those criteria.
Note: For IVD devices, acceptance criteria typically include parameters like:
- Precision/Reproducibility: Within-run, between-run, total precision (e.g., %CV at various concentrations).
- Accuracy/Method Comparison: Correlation and agreement with a reference method or predicate device (e.g., Deming regression analysis, absolute bias).
- Linearity/Analytical Measurement Range: The range over which results are proportional to the analyte concentration.
- Limit of Detection (LoD) / Limit of Quantitation (LoQ): The lowest concentration that can be reliably detected/quantified.
- Interferences: Effects of common interfering substances (hemolysis, lipemia, icterus, etc.).
- Specificity: Cross-reactivity with structurally similar compounds.
- Stability: Reagent and calibration stability.
Since these specific quantitative criteria and results are not detailed in the provided text, a comprehensive table cannot be generated. The document only confirms that "The data presented [...] is the data that the Food and Drug Administration used in granting DPC substantial equivalence."
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes used for the analytical performance studies (test sets) or the provenance (country of origin, retrospective/prospective nature) of the samples. For IVD devices, samples are typically patient samples (serum, plasma) collected under defined protocols to assess analytical performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. For IVD assays measuring biomarkers, "ground truth" is typically established by reference methods, comparison to predicate devices, or clinical diagnosis. The analytical performance studies do not involve experts establishing a "ground truth" in the way a radiological image interpretation study would.
4. Adjudication method for the test set
N/A. Adjudication methods (like 2+1 or 3+1) are common in image interpretation studies or clinical trials where expert consensus is needed to define a ground truth from subjective assessments. This is not applicable to quantitative biomarker measurements in IVD devices.
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
N/A. This is an IVD device measuring biomarkers, not an AI-driven image analysis tool or decision support system that would involve human "readers" or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in a sense, the device operates in a standalone manner as an automated immunoassay system. The analytical performance studies evaluate the device's ability to accurately and precisely measure the target biomarkers in biological samples without direct human-in-the-loop interpretational performance being part of the primary evaluation. The "performance" here refers to the analytical performance of the assay itself.
7. The type of ground truth used
For these IVD products, the "ground truth" for evaluating analytical performance is typically:
- Reference methods: Highly accurate and precise laboratory methods.
- Predicate device comparison: Measurement of the same samples on a legally marketed, substantially equivalent predicate device.
- Assigned values: For quality control materials or calibrators, values might be assigned through rigorous consensus or characterization methods.
- Clinical diagnosis: While not directly establishing "ground truth" for the biomarker level itself, samples may be derived from patients with confirmed clinical diagnoses (e.g., AMI positive, non-AMI negative) to assess clinical performance characteristics (e.g., diagnostic sensitivity and specificity), though this specific detail is not provided in the summary.
The document implicitly suggests that the ground truth was established through comparison with the predicate devices (IMMULITE/IMMULITE 1000 Turbo CK-MB, IMMULITE/IMMULITE 1000 Turbo Myoglobin, IMMULITE/IMMULITE 1000 Turbo Troponin I), common practice for demonstrating substantial equivalence.
8. The sample size for the training set
N/A. This is an immunoassay kit, not an AI/ML device that requires a training set in the computational sense. The "training" of such a system involves the development and optimization of the chemical reagents and assay protocols.
9. How the ground truth for the training set was established
N/A. As above, the concept of a "training set" and establishing ground truth for it is not applicable to a traditional immunoassay. Assay development involves optimizing reagents and parameters to achieve desired analytical performance characteristics.
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JAN 2 1 2004
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:Address: | Diagnostic Products Corporation5700 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: | December 24, 2003 |
| Device Name:Trade: | IMMULITE® 2500 CK-MB |
| Catalog Number: | L5KCP2 (200 tests), L5KCP6 (600 tests) |
| CFR: | A creatine phosphokinase/creatine kinase or isoenzymes testsystem is a device intended to measure the activity of the enzymecreatine phosphokinase or its isoenzymes (a group of enzymeswith similar biological activity) in plasma and serum.Measurements of creatine phosphokinase and its isoenzymes areused in the diagnosis and treatment of myocardial infarction andmuscle diseases such as progressive, Duchenne-type musculardystrophy. |
| 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/IMMULITE 1000 Turbo CK-MB (K022118)
Description of Device:
2500 CK-MB is a solid-phase, two-site IMMULITE chemiluminescent enzyme immunoassay for use with the IMMULITE 2500 Automated Analyzer.
Intended Use of the Device:
IMMULITE 2500 CK-MB is a solid-phase, two-site chemiluminescent enzyme immunoassay for use with the IMMULITE 2500 Automated Analyzer and is intended strictly for in vitro diagnostic use for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction.
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 2500 CK-MB.
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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: | December 24, 2003 |
| Device Name:Trade: | IMMULITE® 2500 Myoglobin |
| Catalog Number: | L5KMY2 (200 tests), L5KMY6 (600 tests) |
| CFR: | A myoglobin immunological test system is a device that consistsof the reagents used to measure by immunochemical techniquesthe myoglobin (an oxygen storage protein found in muscle) inserum and other body fluids. Measurement of myoglobin aids inthe rapid diagnosis of heart or renal disease. |
| Common: | Reagent system for the determination of myoglobin in serum andplasma. |
| Classification: | Class II device, DDR (21CFR 866.5680) |
| 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 |
| SubstantiallyEquivalent |
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IMMULITE/IMMULITE 1000 Turbo Myoglobin (K991796) Predicate Device: IMMULITE 2500 Myoglobin is a solid-phase, two-site Description of Device: chemiluminescent enzyme immunoassay for use with the IMMULITE 2500 Automated Analyzer.
Intended Use of the Device:
IMMULITE 2500 Myoglobin is a solid-phase, two-site chemiluminescent enzyme immunoassay for use with the IMMULITE 2500 Automated Analyzer and is intended strictly for in vitro diagnostic use for the quantitative measurement of myoglobin in serum and heparinized plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).
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 2500 Myoglobin.
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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: | (310) 645-8200 |
| Facsimile Number: | (310) 645-9999 |
| Contact Person: | Edward M. Levine, Ph.D.Director, Clinical Affairs |
| Date of Preparation: | December 24, 2003 |
| Device Name:Trade: | IMMULITE® 2500 STAT Troponin I |
| Catalog Number: | L5KSTI2 (200 tests), L5KSTI6 (600 tests) |
| CFR: | Device intended to measure the activity of the enzyme creatinekinase isoenzymes (a group of enzymes with similar biologicalactivity) in plasma and serum. Measurements of creatinephosphokinase isoenzymes are used in the diagnosis andtreatment of myocardial infarction and muscle diseases such asprogressive, Duchenne-type muscular dystrophy. |
| Common: | Reagent system for the determination of troponin I in serum andplasma. |
| Classification: | Class II device, MMI (21CFR 866.1215) |
| 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 |
| Substantially |
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Equivalent Predicate Device:
IMMULITE/IMMULITE 1000 Turbo Troponin I (K991795)
Description of Device:
IMMULITE 2500 STAT Troponin I is a solid-phase, two-site chemiluminescent enzyme immunoassay for use with the IMMULITE 2500 Automated Analyzer.
Intended Use of the Device:
IMMULITE 2500 STAT Troponin I is a solid-phase, two-site chemiluminescent enzyme immunoassay for use with the IMMULITE 2500 Automated Analyzer and is intended strictly for in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).
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 2500 STAT Troponin I.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping wavy lines.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 2 1 2004
Edward M. Levine, Ph.D. Director of Clinical Affairs Diagnostic Products Corporation 5700 West 96th Street Los Angeles, CA 90045-5597
Re: K034055 Trade/Device Name: Immulite® 2500 CK-MB Immulite® 2500 Myoglobin Immulite® 2500 STAT Troponin I Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: JHX; MMI; DDR Dated: December 24, 2003 Received: December 30, 2003
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 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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper, MS, DVM.
Jean M. Cooper, MS, D.V.M. 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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Ko34055
510(k) Number (if known): . . . . IMMULITE® 2500 CK-MB Device Name: IMMULITE® 2500 Myoglobin IMMULITE® 2500 STAT Troponin I
Indications For Use:
The IMMULITE 2500 CK-MB is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction.
The IMMULITE 2500 Myoglobin is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of myoglobin in serum and heparinized plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).
The IMMULITE 2500 STAT Troponin I is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carol C. Benembi Jean Cooper, DVM
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Prescription Use
(Per 21 CFR 801.109)510(k) K034655 Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.