(286 days)
The Audit™ MicroCVTM Homocysteine Linearity Set is assayed quality control material consisting of five levels human based serum. Each level contains Homocysteine analyte. The five levels demonstrate a linear relationship to each other for Homocysteine analyte. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification and verification of reportable range for Homocysteine. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling. The Audit™ MicroCVTM Homocysteine Linearity Set should not be used for calibration or standardization of the Homocysteine assay. The Audit™ MicroCV™ Homocysteine Linearity Set is "For In Vitro Diagnostic Use Only".
The Audit™ MicroCV™ Homocysteine Linearity Set is a human based, liquid, five level set of QC material, with each level containing one analyte: Homocysteine. It is used to confirm the proper calibration, linear operating range, and reportable range of Homocysteine. 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 describes a 510(k) premarket notification for the "Audit™ MicroCV™ Homocysteine Linearity Set." This device is a quality control material intended to verify linearity, calibration, and reportable range for Homocysteine assays. The primary focus of the document is to demonstrate substantial equivalence to predicate devices, rather than an extensive study proving the device meets specific acceptance criteria through a clinical trial.
Therefore, many of the requested elements (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of submission for a quality control material.
However, the document does provide information related to the device's performance through stability studies, which are crucial for a quality control product.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
For the Audit™ MicroCV™ Homocysteine Linearity Set, the key performance aspects are stability. The acceptance criteria for stability would be that the Homocysteine analyte remains stable within specified storage conditions for defined periods. The reported performance suggests these criteria were met.
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Stability (Open Vial) | Homocysteine stable for a specified duration when stored at 2-8°C, capped. | 10 days when stored tightly capped at 2 - 8° C. |
| Stability (Shelf Life) | Homocysteine stable for a specified duration when stored unopened at 2-8°C. | Two years, when stored unopened at 2 - 8° C. (Real-time studies ongoing) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not directly applicable in the context of a 510(k) for a QC material. The "test set" here refers to samples used in stability studies. The document states "All supporting data is retained on file at Aalto Scientific, Ltd.," but does not specify the number of individual vials or batches tested for stability.
- Data Provenance: The studies were performed by Aalto Scientific, Ltd. The document does not specify the country of origin of the data beyond the company's location (Carlsbad, CA). The studies are inherent to the product development and are effectively prospective with respect to determining product stability claims, although the testing itself retrospectively assesses manufactured lots.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable. For a quality control material, the "ground truth" for linearity and analyte concentration is established by the manufacturer through their validated assay methods and manufacturing processes, not by external experts reviewing test results.
4. Adjudication method for the test set
- Not applicable as there is no independent ground truth review or adjudication process described for the performance of a QC material. Performance is assessed against internal specifications and validated analytical methods.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is an in vitro diagnostic quality control material, not an AI-powered diagnostic tool requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a reagent for laboratory testing, not an algorithm.
7. The type of ground truth used
- For the Audit™ MicroCV™ Homocysteine Linearity Set, the "ground truth" (or reference values) for Homocysteine concentrations in the linearity levels are established by the manufacturer's validated analytical methods and manufacturing control processes. The claim of linearity is derived from the controlled dilution of known concentrations.
8. The sample size for the training set
- Not applicable. There is no machine learning model or "training set" in the context of this traditional IVD quality control device.
9. How the ground truth for the training set was established
- Not applicable for the same reason as point 8.
Summary of the Study Proving Acceptance Criteria:
The document briefly mentions "Stability studies have been performed to determine the open vial stability and shelf life for the Audit™ MicroCV™ Homocysteine Linearity Set." These studies, which are not detailed in this summary, would involve:
- Methodology: Testing multiple batches of the product under specified storage conditions (e.g., 2-8°C, tightly capped for open vial; 2-8°C unopened for shelf life). Samples would be analyzed for Homocysteine concentration at defined time points using a validated analytical method (e.g., an enzymatic assay or HPLC, typically the method the QC material is intended for).
- Acceptance Criteria for Stability Studies: The Homocysteine concentration measured at various time points within the specified storage conditions must remain within predefined acceptable limits (e.g., ±X% of the initial concentration or within a certain confidence interval) to support the claims of 10-day open vial stability and 2-year shelf life.
- Data: The document states, "All supporting data is retained on file at Aalto Scientific, Ltd." This indicates that comprehensive results from these stability studies exist, showing that the product met these internal acceptance criteria for stability.
- Ongoing Studies: The note "Real time studies are ongoing to support the shelf life of this product" indicates a standard regulatory practice where accelerated stability data might initially support a shelf life claim, but real-time studies continuously confirm it over the product's full intended shelf life.
In conclusion, the performance of this device, a quality control material, is primarily demonstrated through rigorous internal stability studies, not through external clinical trials or expert-adjudicated test sets as would be the case for a diagnostic device that interprets patient data. The summary provided here focuses on the outcome of these studies (the stated stability claims) rather than the detailed experimental design.
§ 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.