(216 days)
The Audit™ MicroCV™ hs-CRP Linearity Set is assayed quality control material consisting of five levels human based serum. Each level contains High Sensitivity C-Reactive Protein (hs -CRP) analyte. The five levels demonstrate a linear relationship to each other for High Sensitivity C-Reactive Protein (hs -CRP) analyte. It is intended to simulate human patient serum samples for purpose of monitoring and detecting systematic analytical deviations of laboratory testing procedures for High Sensitivity C-Reactive Protein (hs -CRP). This product may be used as quality control material for High Sensitivity C-Reactive Protein (hs -CRP) analyte. 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 the indicated analyzer provided in the labeling. The Audit™ MicroCVTM hs-CRP Linearity Set is "For In Vitro Diagnostic Use Only".
The Audit™ MicroCVTM hs-CRP Linearity Set is a human based, liquid, five level set of QC material, with each level containing one analyte: High Sensitivity C-Reactive Protein (hs -CRP). It is used to confirm the proper calibration, linear operating range, and reportable range of hs-CRP. Level A has concentration near the lower limit level and Level E has concentrations near the upper limit level of instruments. Levels B – D are related by linear dilution of Level A and Level E.
The provided document does not contain explicit acceptance criteria and a study to prove the device meets these criteria in the typical format of a medical device performance study (e.g., accuracy, sensitivity, specificity). Instead, the document describes a quality control material and its stability.
Here's an analysis based on the information provided, framed to address your questions where possible, and highlighting what is not present:
Device: Audit™ MicroCV™ hs-CRP Linearity Set
Intended Use (from the document):
"The Audit™ MicroCV™ hs-CRP Linearity Set is assayed quality control material consisting of five levels human based serum. Each level contains High Sensitivity C-Reactive Protein (hs -CRP) analyte. The five levels demonstrate a linear relationship to each other for High Sensitivity C-Reactive Protein (hs -CRP) analyte. It is intended to simulate human patient serum samples for purpose of monitoring and detecting systematic analytical deviations of laboratory testing procedures for High Sensitivity C-Reactive Protein (hs -CRP). This product may be used as quality control material for High Sensitivity C-Reactive Protein (hs -CRP) analyte. 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 the indicated analyzer provided in the labeling. The Audit™ MicroCV™ hs-CRP Linearity Set is 'For In Vitro Diagnostic Use Only'."
1. Table of Acceptance Criteria and Reported Device Performance
For quality control materials like this, "acceptance criteria" usually relate to their stability (shelf life, open vial stability) and their ability to demonstrate a linear relationship. The document outlines these stability claims as performance.
| Characteristics | Acceptance Criteria (Implied / Claimed) | Reported Device Performance |
|---|---|---|
| Open Vial Stability | Expected to be stable for a specified duration when stored as instructed. | 10 days when stored tightly capped at 2-8°C. |
| Shelf Life | Expected to be stable for a specified duration when stored as instructed. | Two years at 2-8°C. |
| Linearity | The five levels are expected to demonstrate a linear relationship to each other for hs-CRP analyte, as they are related by linear dilution. | "The five levels demonstrate a linear relationship to each other for hs-CRP analyte." (This is stated in the intended use, implying they meet this design goal.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "sample size" in terms of how many units of the linearity set were tested for stability or linearity demonstration. It refers to "five level set of QC material" and "five levels human based serum" which implies testing was performed on these five levels per set. The number of individual sets or batches tested is not stated.
- Data Provenance: Not explicitly stated, but the studies were "performed to determine the shelf life" and all supporting data "is retained on file at Aalto Scientific, Ltd." This suggests internal, retrospective testing conducted by the manufacturer (Aalto Scientific, Ltd., Carlsbad, CA). There is no mention of country of origin for the data or whether it was prospective/retrospective beyond the general phrasing for stability studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable to this type of device. The "Audit™ MicroCV™ hs-CRP Linearity Set" is a quality control material, not a diagnostic device that produces results requiring interpretation by experts against a ground truth. Its "ground truth" (or established values for each level) would be determined by precise analytical methods and certified reference materials, not expert consensus. The linearity is a characteristic of the set itself.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods (like 2+1, 3+1) are used in studies where human readers interpret diagnostic results (e.g., medical images) and their interpretations need to be reconciled to establish a consensus ground truth. This is not relevant for a quality control linearity set.
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 used to compare the diagnostic performance of different methods or human readers, often involving AI assistance, when interpreting patient cases. The device described here is a quality control material, not a diagnostic tool requiring such a study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical quality control material used with analytical instruments, not an algorithm. Therefore, "standalone performance" in the context of an algorithm is irrelevant.
7. The Type of Ground Truth Used
For stability studies, the "ground truth" would be the initial, accurately measured concentration of hs-CRP in each level of the material. Subsequent measurements over time are compared to these initial values to determine if the material remains within acceptable analytical variation. For linearity, the "ground truth" is that the levels B, C, D are derived by linear dilution of levels A and E, so the expectation is a proportional relationship in measured values.
The document implicitly refers to:
- Analytically determined values: The hs-CRP concentrations are established through quantitative assays.
- Designed characteristics: The linear relationship between levels A-E is a design feature ("Levels B – D are related by linear dilution of Level A and Level E").
There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this product.
8. The Sample Size for the Training Set
This is not applicable. The device is a quality control material, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
This is not applicable, as there is no training set for this product.
§ 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.