(27 days)
The Randox Microalbumin Liquid Controls are designed for use as assayed quality control materials for the quantitative determination of albumin in human urine. This in vitro diagnostic device is intended for prescription use only and can only be used by professionals.
Randox Microalbumin Controls are manufactured at two levels, Level 1 and Level 2. They are single analyte controls made with human serum. The analyte concentrations in each control have been reviewed by a panel of experts to ensure that the concentrations are clinically relevant for use in routine hospital laboratories.
Acceptance Criteria and Device Performance Study for Randox Microalbumin Control Level 1 and Level 2 (Liquid)
1. Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Level 1 (MA041) | ||
| Target Value | 30 mg/L | 30 mg/L (based on average of various analyzers) |
| Manufacturing Range | 20 - 40 mg/L | 20 - 40 mg/L |
| %CV | ≤ 5 | Not explicitly stated, but implies ≤ 5 as passing |
| % Recovery Error | ≤ 5 | Not explicitly stated, but implies ≤ 5 as passing |
| Level 2 (MA042) | ||
| Target Value | 150 mg/L | 150 mg/L (based on average of various analyzers) |
| Manufacturing Range | 130 – 170 mg/L | 130 – 170 mg/L |
| %CV | ≤ 5 | Not explicitly stated, but implies ≤ 5 as passing |
| % Recovery Error | ≤ 5 | Not explicitly stated, but implies ≤ 5 as passing |
Note: The reported device performance for %CV and % Recovery Error is inferred from the statement "The CV% and % recovery error result should fall within the range shown below," indicating that the study results met these criteria. Specific numerical values for the reported performance were not provided in the document beyond meeting the acceptable range.
2. Sample Size and Data Provenance for Test Set
- Sample Size: 10 replicates were run for each control level (Level 1 and Level 2) on each of the following analyzers: Hitachi 717, Cobas Mira, RX Daytona, and Dimension.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It implies prospective testing conducted by Randox Laboratories.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
The document states: "The analyte concentrations in each control have been reviewed by a panel of experts to ensure that the concentrations are clinically relevant for use in routine hospital laboratories."
- Number of Experts: A "panel of experts" (specific number not given).
- Qualifications of Experts: Not explicitly stated, but their role suggests expertise in clinical chemistry, laboratory medicine, or related fields relevant to albumin measurement in urine and quality control.
4. Adjudication Method for Test Set
The adjudication method is not explicitly stated. The "Target Value" for each control level was assigned based on "the average of all the results from the various analysers," and a range of +/- 20% was then applied to this average to define the "Acceptable Manufacturing Range." This suggests a statistical averaging approach rather than a specific expert adjudication method like 2+1 or 3+1 for individual results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a quality control material, not an AI-powered diagnostic device, so a study comparing human readers with and without AI assistance is not applicable.
6. Standalone Performance Study
Yes, a standalone study was performed. The "Summary of Value Assignment" describes the testing of the control material on various analyzers (Hitachi 717, Cobas Mira, RX Daytona, and Dimension) to determine a target value and confirm the acceptable manufacturing range, %CV, and % Recovery Error. This represents the performance of the control material itself, without human interpretation as part of the primary outcome.
7. Type of Ground Truth Used (Test Set)
The ground truth used for the test set (value assignment) appears to be derived from the average of quantitative measurements obtained from multiple established laboratory analyzers. This effectively serves as a consensus-based quantitative ground truth established through instrument performance on the control samples. Additionally, a "panel of experts" reviewed the assigned concentrations for clinical relevance.
8. Sample Size for Training Set
The document does not describe a distinct training set in the context of an algorithm or AI model development. This device is a chemical control material, not an AI diagnostic algorithm. Therefore, "training set" as understood in AI/ML is not applicable here. The "value assignment" phase is more akin to a calibration or characterization study.
9. How Ground Truth for Training Set Was Established
As noted above, there is no distinct "training set" in the context of AI. For the value assignment (which can be considered analogous to establishing the 'correct' values for the control material), the ground truth was established by:
- Running 10 replicates of the control material on four different widely-used laboratory analyzers (Hitachi 717, Cobas Mira, RX Daytona, and Dimension).
- Calculating the average of all results from these various analyzers to assign the "Target Value."
- Reviewing these concentrations by a "panel of experts" to ensure clinical relevance.
§ 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.