(17 days)
Dade TRU-Liquid Cardiac Control is intended for use as an assayed quality control material in clinical laboratory quality assurance programs and to assist in the control of accuracy and precision of a laboratory's cardiac marker procedures.
Dade® TRU-Liquid™ Cardiac Control Levels 1,2 and 3. Liquid Tri-Level Cardiac Control. Quality Control Material (Assayed and Unassayed).
This document is a 510(k) summary for a medical device called "Dade® TRU-Liquid™ Cardiac Control." It is a quality control material intended for use in clinical laboratory quality assurance programs to assess the accuracy and precision of cardiac marker procedures. The document states that the device is "substantially equivalent" to a previously cleared predicate device, the "Liquichek Cardiac Markers Control" manufactured by Bio-Rad Laboratories (K961828).
Based on the provided text, the following information can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state specific quantitative acceptance criteria (e.g., specific ranges for accuracy, precision, or recovery) or provide detailed performance data for the Dade® TRU-Liquid™ Cardiac Control device.
Instead, the core of the submission is a demonstration of substantial equivalence to a predicate device. This means the device is considered acceptable if it performs comparably to the predicate device for its intended use. The document affirms this substantial equivalence, but it does not present the direct experimental results that led to that conclusion for the new device.
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance (Inferred from Substantial Equivalence) |
|---|---|
| Performance comparable to the predicate device (Liquichek Cardiac Markers Control, K961828) for controlling accuracy and precision of cardiac marker procedures. | Declared "substantially equivalent" in terms of intended use, safety, and effectiveness to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided text.
- Data Provenance: Not specified in the provided text. The document refers to the predicate device (K961828) which would have had its own testing, but details on the testing of the Dade® TRU-Liquid™ Cardiac Control itself are absent from this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable and not provided. The device is a quality control material, not a diagnostic device requiring expert interpretation of results to establish ground truth. Its "truth" is based on the known concentrations of analytes within the control material, which are then used to assess other diagnostic assays.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods are typically used for diagnostic devices where human interpretation or consensus is required for complex cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This type of study is relevant for diagnostic devices that involve human readers interpreting medical images or data. The Dade® TRU-Liquid™ Cardiac Control is a quality control material for laboratory instruments/assays.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study (in the context of AI algorithms) was not done. This device is not an AI algorithm. Its performance is evaluated through its stability, homogeneity, and accuracy of assayed values when used to calibrate or check other diagnostic assays.
7. The Type of Ground Truth Used
For a quality control material like this, the "ground truth" would be the assigned or assayed values (known concentrations) of the cardiac markers within the control material itself. These values are typically established through rigorous analytical methods, often by the manufacturer using reference methods or certified reference materials. The purpose of the control is then to ensure that clinical laboratory instruments/assays accurately measure these known concentrations.
8. The Sample Size for the Training Set
This information is not applicable and not provided. A "training set" refers to data used to train machine learning models. This device is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided, as there is no training set for this type of device.
§ 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.