(28 days)
Liquichek Specialty Immunoassay Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures listed in the package insert.
Liquichek Specialty Immunoassay Control is prepared from human serum with added constituents of human and animal origin, chemicals, stabilizers, and preservatives. This provided in liquid form.
Here's an analysis of the provided text regarding the Liquichek Specialty Immunoassay Control, extracting the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
For this device, "acceptance criteria" and "reported device performance" are primarily related to its stability as a quality control material. The document doesn't present a traditional "performance" in terms of diagnostic accuracy (like sensitivity/specificity) but rather the duration for which it can reliably perform its intended function of monitoring precision.
| Acceptance Criteria/Performance Aspect | Reported Device Performance |
|---|---|
| Open Vial Stability (2-8°C) | 30 days |
| Exception for Anti-Tg and Anti-TPO | 21 days |
| Shelf Life Stability (-20 to -70°C) | 2 Years |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify a sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It simply states that "Stability studies have been performed..." and "All supporting data is retained on file at Bio-Rad Laboratories."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. For a quality control material, "ground truth" would typically refer to the accurately assigned values for each analyte within the control material. This is usually established through highly accurate reference methods or certified reference materials, not necessarily by a panel of human experts in the diagnostic sense.
4. Adjudication Method for the Test Set
This information is not provided in the document. As this is a quality control material and not a diagnostic device with subjective interpretations, traditional adjudication methods are not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, and the AI's impact on their performance is being evaluated. This document describes a quality control material, not a diagnostic device intended for human interpretation.
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 an "algorithm" or "AI" was not performed. This device is a biochemical control material, not an AI software or algorithm. Its performance is related to its chemical stability and its ability to maintain known analyte concentrations over time.
7. The Type of Ground Truth Used
The "ground truth" for a quality control material like this would be the assigned target values and acceptable ranges for each analyte within the control. These values are typically established through rigorous analytical testing using reference methods and/or certified reference materials during the manufacturing process. The document does not explicitly state the methodology for establishing these initial values, but it's inherent to the nature of a quality control product.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. This device is a physical biochemical product, not an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore not provided. As explained above, 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.