(8 days)
An assayed quality control serum to monitor the precision of laboratory testing procedures for analytes listed in the package insert.
Liquichek™ Immunology Control is prepared from human serum with added serum proteins, constituents of animal origin, preservatives and stabilizers. The control is provided in liquid form for convenience.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stability Claims) | Reported Device Performance |
|---|---|
| Open Vial Stability: All analytes stable for 30 days when stored tightly capped at 2 to 8°C. | Once the product is thawed and opened, all analytes will be stable for 30 days when stored tightly capped at 2 to 8°C. |
| Open Vial Exception: Rheumatoid Factor stable for 21 days when stored tightly capped at 2 to 8°C. | Rheumatoid Factor will be stable for 21 days when stored tightly capped at 2 to 8°C. |
| Closed Vial Stability: All analytes stable for 90 days once thawed and stored unopened at 2 to 8°C. | Once thawed and stored unopened at 2 to 8°C, all analytes will be stable for 90 days. |
| Shelf Life: Two years when stored at -10 to -20 °C. | Two years when stored at -10 to -20 °C. (Stated as a claim, with ongoing real-time studies.) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the stability studies (test set). It mentions "Stability studies have been performed," but does not provide details on the number of batches, vials, or measurements taken. The data provenance is also not specified. It is likely that the testing was conducted at Bio-Rad Laboratories (the submitter and manufacturer) in Irvine, California. The studies are described as "real-time studies will be ongoing to support the shelf life," suggesting a prospective nature for the shelf-life portion, while the open and closed vial stability studies likely involved specific testing periods to establish those claims.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this device and study type. The "ground truth" for a quality control material like Liquichek™ Immunology Control is its stability over time under specified conditions, determined by analytical testing methods to measure analyte concentrations. It does not involve expert interpretation or clinical diagnosis.
4. Adjudication Method for the Test Set
This information is not applicable to this device and study type. Clinical adjudication methods (like 2+1, 3+1) are used for studies involving subjective interpretations (e.g., medical imaging), which is not the case for a quality control material demonstrating analytical stability.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is designed to assess the impact of a device (often AI-based) on human reader performance in diagnostic tasks, which is not relevant for an immunology quality control product. The purpose of this submission is to demonstrate the stability and substantial equivalence of the quality control material itself.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done, as this product is not an algorithm or AI-driven diagnostic device. The performance refers to the stability of the control material's analytes.
7. The Type of Ground Truth Used
The "ground truth" for the stability studies is established through analytical testing methods to quantify the concentration of each analyte in the control material over time under various storage conditions. The acceptable range for these concentrations (what constitutes "stable") would be defined internally by Bio-Rad Laboratories based on established analytical performance specifications. It is a measurement-based ground truth, not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
This information is not applicable. This device is an immunology control product, not an algorithm that requires a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no "training set" for this 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.