(32 days)
Dade TRU-Liquid Cardiac Control is intended for use as an assayed quality control material in clinical laboratory quality assurance quarrer control accession the control of accuracy and precision of a laboratory's cardiac market procedures, specifically Troponin I, CK-MB, and Myoglobin.
Liquid Tri-Level Cardiac Control
The provided text is a 510(k) summary for a medical device called "Dade® TRU-Liquid™ Cardiac Control." This document focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than detailing a study that proves the device meets specific acceptance criteria in the way a clinical performance study would for a diagnostic or therapeutic device.
Therefore, many of the requested categories (acceptance criteria table, sample sizes, ground truth establishment, expert qualifications, MRMC study, standalone performance) are not applicable or detailed in this type of regulatory submission for a quality control material.
However, I can extract the relevant information that is present:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not explicitly provided in the format of a table with specific acceptance criteria (e.g., precision limits, accuracy targets) and corresponding reported performance for the TRU-Liquid Cardiac Control itself. The document's primary focus is on demonstrating substantial equivalence to a predicate device (Liquichek Cardiac Markers Control). This implies that the performance of the new device is expected to be comparable to this legally marketed predicate.
The document states: "The proposed Dade® TRU-Liquid™ Cardiac Control is substantially equivalent in terms of intended use and safety and effectiveness to the Liquichek Cardiac Markers Control manufactured by Bio-Rad Laboratories, previously cleared under Document Control No., K961828."
This "substantial equivalence" is the overarching acceptance criterion, evaluated by comparing the new device's characteristics and intended use to those of the predicate. The performance data that supports this would typically be found in the full 510(k) submission, not necessarily in this summary document.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. This document does not describe a clinical performance study with a test set of patient samples. The "test" for this device likely involved laboratory characterization and comparison to the predicate, but specific sample sizes for such internal testing are not provided in this summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This is a quality control material, not a diagnostic device requiring expert interpretation of patient data to establish ground truth.
4. Adjudication Method for the Test Set:
Not applicable for the same reason as above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. An MRMC study is relevant for devices involving human interpretation of clinical data (e.g., imaging devices). This is a quality control material.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a quality control material, not an algorithm or an automated system.
7. The Type of Ground Truth Used:
Not applicable in the sense of patient outcomes, pathology, or expert consensus on clinical findings. For a quality control material, the "truth" is typically established through precise analytical methods and characterization of the material itself (e.g., target analyte concentrations determined by reference methods). The document implies that the "truth" for demonstrating equivalence relies on comparing the new device's characteristics to those of the predicate device.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable.
Summary of available information:
- Device Type: Quality Control Material (Liquid Tri-Level Cardiac Control) for Troponin I, CK-MB, and Myoglobin.
- Regulatory Basis: Substantial equivalence to a legally marketed predicate device (Liquichek Cardiac Markers Control, K961828).
- Intended Use: Assayed quality control material in clinical laboratory quality assurance for accuracy and precision of cardiac marker procedures.
- Study described: No specific clinical or performance study with defined acceptance criteria and performance results is detailed within this summary. The entire 510(k) process is based on demonstrating the device's equivalence to a predicate, which implies that appropriate testing was performed to support this claim, but the details are not in this public summary.
§ 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.