(184 days)
The Audit™ MicroCV™ Free T4 / Free T3 Linearity Set consists of five levels of human and bovine albumin based matrix. Each level contains the following analytes: Free T4 and Free T3. The five levels demonstrate a linear relationship to each other for their respective analytes, reagents, and instruments.
This product may also be used as a quality control material for these analytes. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The product is intended for use with quantitative assays on automatic analyzers. The Audit™ Free T4 / Free T3 Linearity Set is "For In Vitro Diagnostic Use Only".
The Audit™ MicroCV™ Free T4 / Free T3 Linearity Set is a 5 level quality control solution set containing Free T4 / Free T3 analytes as the messurand. It is used to confirm the proper calibration, linear operating range, and reportable range of Free T4 / Free T3 analytes. Level A is near the lower limit level and Level E has concentrations near the upper limit of instruments. Levels B - D are related by linear dilution of Level A and Level E.
The provided text describes the Audit™ MicroCV™ Free T4 / Free T3 Linearity Set, a quality control solution set. The primary study presented focuses on the stability of this device, rather than a clinical performance study involving human readers or comparative effectiveness for diagnostic tasks.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Open Vial Stability | 5 days when stored tightly capped at 2-8°C. |
| Shelf Life | 24 months at 2 - 8°C. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated for the stability studies. The product has 5 levels (A-E), each containing Free T4 and Free T3 analytes, but the number of aliquots or replicates tested is not provided.
- Data Provenance: The studies were performed at Aalto Scientific, Ltd. The text does not specify the country of origin of the data beyond this. The studies are described as "Real time studies are ongoing to support the shelf life," implying they are prospective for shelf-life, and likely involve experimental data generated in a lab setting rather than retrospective patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This question is not applicable to this submission. The device is a linearity set for calibration verification and quality control, not a diagnostic device that requires expert interpretation of results to establish ground truth for a test set. The 'ground truth' for this device would be the expected concentrations and their linear relationship, established through analytical methods.
4. Adjudication Method for the Test Set
- This question is not applicable. There's no mention of an adjudication process, as the device doesn't involve subjective interpretations that would require expert consensus.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data, and an AI's assistance is being evaluated. The Audit™ MicroCV™ Free T4 / Free T3 Linearity Set is an in vitro diagnostic quality control material, not a diagnostic imaging or data interpretation system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable in the context of an algorithm or AI. The "device" here is a physical reagent set. The performance is assessed by its chemical and physical stability, which are intrinsic properties of the material and do not involve an algorithm.
7. The Type of Ground Truth Used
- The ground truth for the stability studies would be analytical measurements of the Free T4 and Free T3 analyte concentrations over time and under specified storage conditions. The stability is determined by comparing these measured values against pre-defined acceptance limits for changes in concentration, or maintenance of linearity, which indicates the product's integrity. The text states, "It is used to confirm the proper calibration, linear operating range, and reportable range of Free T4 / Free T3 analytes." This implies the "ground truth" is adherence to these established analytical parameters.
8. The Sample Size for the Training Set
- This concept is not applicable. The device is a linearity set for quality control, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- This concept is not applicable, as there is no training set for an AI/ML algorithm.
§ 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.