(259 days)
The Audit™ MicroCV™ Protein Linearity is assayed quality control material consisting of five levels protein (human) based serum. Each level contains Alpha-1-Antitrypsin, Complement C3, Complement C4, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M and Transferrin analytes. The five levels demonstrate a linear relationship to each other for Alpha-1-Antitrypsin, Complement C3, Complement C4, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M, and Transferrin analytes. It is intended to simulate human patient serum samples and to detect systematic analytical deviations of laboratory testing procedures for Alpha-1-Antitrypsin, Complement C3, Complement C4, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M, and Transferrin. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling. The Audit MicroCV Protein Linearity Set is "For In Vitro Diagnostic Use Only."
The Audit™ MicroCVTM Protein Linearity Set is a human based, five level set of QC material, with each level containing seven analytes: Aipha-1-Antitrypsin, Complement C3, Complement C4, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M, and Transferrin. It is used to confirm the proper calibration, linear operating range, and reportable range of the analytes listed. 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 a 510(k) premarket notification for a medical device called the Audit™ MicroCV™ Protein Linearity Set. The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance data in the format requested.
Here's an attempt to extract and infer the information based on the provided text, while acknowledging that many fields cannot be fully populated as they are not explicitly stated in the 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state numerical acceptance criteria for a study comparing the device's performance against a standard or ground truth. Instead, it asserts "substantial equivalence" to a predicate device based on similar intended use and technical characteristics, and verifies stability claims.
| Acceptance Criteria (Inferred from intended use and stability claims) | Reported Device Performance (Summary) |
|---|---|
| Intended Use: Device demonstrates linear relationship for specified analytes and detects systematic analytical deviations. | The device consists of five levels that demonstrate a linear relationship for Alpha-1-Antitrypsin, Complement C3, Complement C4, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M, and Transferrin analytes. It is intended to simulate human patient serum samples and to detect systematic analytical deviations. |
| Open Vial Stability: All analytes stable for 1 day when stored tightly capped at 2 - 8° C. | Stability studies performed to determine open vial stability. "All supporting data is retained on file." Claims: 1 day stability at 2 - 8° C. |
| Shelf Life: One year when stored unopened at 2 - 8° C. | Stability studies performed to determine shelf life. "All supporting data is retained on file." Claims: 1 year shelf life at 2 - 8° C. "Real time studies are ongoing to support the shelf life." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of a clinical or performance study where individual samples were analyzed and results compared to a ground truth. The performance data primarily refers to stability studies.
- Sample Size for Test Set: Not specified. The linearity set itself contains "five levels" of QC material.
- Data Provenance: Not explicitly stated, but the stability studies were "performed" by Aalto Scientific, Ltd. The base material is "human based serum." The document does not indicate country of origin for any data or if it was retrospective or prospective beyond the mention of "real time studies are ongoing" for shelf life.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Falls under the same category as point 2. There is no mention of experts establishing ground truth for a test set in the context of this 510(k) submission. The device itself serves as a quality control material to verify instrument linearity.
- Number of Experts: Not applicable/not specified.
- Qualifications of Experts: Not applicable/not specified.
4. Adjudication Method for the Test Set
Not applicable, as a test set and associated adjudication method are not described in this submission.
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 a linearity set (quality control material) for in vitro diagnostic assays, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a quality control material, not an algorithm.
7. The Type of Ground Truth Used
For a linearity set, the "ground truth" is typically established by the manufacturer during the formulation process, ensuring that the five levels are prepared to specific concentrations that demonstrate a linear relationship. This is an intrinsic characteristic of the product's design. The clinical utility is in its ability to aid in verifying the linearity of an analytical instrument by acting as a known linear standard.
- Type of Ground Truth: The linearity and analyte concentrations are inherent properties of the manufactured quality control material, established during its production and characterization by the manufacturer (Aalto Scientific, Ltd., in this case). It relies on the precise formulation and measurement against traceable standards during its development.
8. The Sample Size for the Training Set
Not applicable. This device is a quality control material, not a machine learning model.
9. How the Ground Truth for the Training Set was Established
Not applicable.
§ 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.