(14 days)
The Bayer Liquid Cardiac Markers 1, 2, 3 are assayed control materials for in vitro diagnostic use to monitor the precision and accuracy of immunochemical mass measurement test procedures for the ADVIA Centaur® andACS:180® Systems.
The Bayer Liquid Cardiac Markers 1, 2, 3 are three separate levels of quality control material prepared from human serum with recombinant human CK-MB, human proteins, Digitoxin, Myoglobin, Troponin-I and Homocysteine.
This document is a 510(k) summary for the Bayer Liquid Cardiac Markers 1, 2, 3, which are quality control materials. The purpose of this submission is to demonstrate substantial equivalence to a predicate device, not to present a study proving the device meets specific performance criteria in terms of diagnostic accuracy or impact on human health.
Therefore, much of the requested information regarding acceptance criteria, study design, expert involvement, and comparative effectiveness is not applicable to this type of submission for a quality control material.
Here's an breakdown of the relevant available information and why other sections are not applicable:
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A table of acceptance criteria and the reported device performance
- Not applicable in the context of this 510(k) summary. This document does not detail specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy) for a diagnostic device. It is for a quality control material, whose "performance" is based on its ability to monitor the precision and accuracy of other immunochemical mass measurement test procedures. While the device itself would likely have internal specifications for its constituents and stability, these are not typically presented as "acceptance criteria" in a 510(k) summary for a control material. The submission states the device's "performance" is identical in intended use and fundamental scientific technology to the predicate device.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable in the context of this 510(k) summary. This document does not describe a clinical study with a test set of patient samples. The "test" for a quality control material focuses on its manufacturing specifications, stability, and its ability to produce expected results on the targeted diagnostic systems.
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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)
- Not applicable in the context of this 510(k) summary. There is no "ground truth" to establish in the sense of patient diagnosis for a quality control material.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable in the context of this 510(k) summary. No patient-based test set requiring adjudication is described.
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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 in the context of this 510(k) summary. This is not an AI/CAD device, nor is it a diagnostic device that requires human interpretation. It is a quality control material.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the context of this 510(k) summary. This is not an algorithm-based device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the context of this 510(k) summary. There is no "ground truth" relating to patient diagnosis for a quality control material. The "ground truth" for a control material would be its known assayed values and its ability to consistently fall within specified ranges.
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The sample size for the training set
- Not applicable in the context of this 510(k) summary. This is not a machine learning or AI device that requires a training set.
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How the ground truth for the training set was established
- Not applicable in the context of this 510(k) summary. This is not a machine learning or AI device.
Information relevant to the submission as a quality control material:
- Device Name: Bayer Liquid Cardiac Markers 1, 2, 3
- Intended Use: Assayed control materials for in vitro diagnostic use to monitor the precision and accuracy of immunochemical mass measurement test procedures for the ADVIA Centaur® and ACS:180® Systems.
- Predicate Device: Liquid Cardiac Markers 1,2,3 (Premarket Notification Number: K960246)
- Key Statement for Equivalence: "The Bayer Liquid Cardiac Markers 1, 2, and 3 are identical in intended use and fundamental scientific technology as the previously cleared Liquid Cardiac Markers 1,2, 3. The only difference in these controls is the addition of one new analyte, Homocysteine."
Conclusion:
This 510(k) submission for the Bayer Liquid Cardiac Markers 1, 2, 3 focuses on demonstrating substantial equivalence to a previously cleared quality control material. It does not present a clinical study with acceptance criteria related to diagnostic performance, patient outcomes, or human reader effectiveness. The "study" referenced implicitly is the demonstration that the new device (with the addition of Homocysteine) maintains the same fundamental scientific technology and intended use as the predicate device. The performance of the device is assessed through the lens of its suitability as a control material, not as a diagnostic tool itself.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.