(175 days)
The Audit MicroCV Ammonia/Ethanol Linearity Set is assayed quality control material consisting of five levels protein (bovine) based serum. Each level contains Ammonia and Ethanol analytes. The five levels demonstrate a linear relationship to each other for Ammonia and Ethanol analytes. It is intended to simulate human patient serum samples and to detect systematic analytical deviations of laboratory testing procedures for Ammonia and Ethanol. This product may be used as unassayed quality control material for Ammonia and Ethanol analytes. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling. The Audit MicroCV Ammonia/Ethanol Linearity Set is "For In Vitro Diagnostic Use Only."
The Audit™ MicroCV™ Ammonia/Ethanol Linearity Set is a protein (bovine) based calibration verification material containing multiple levels used to confirm proper calibration, linear operating range, and reportable range of the measured analyte. 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Audit™ MicroCV™ Ammonia/Ethanol Linearity Set:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Open Vial Stability | Not explicitly stated as acceptance criteria, but tested. | 2 days when stored stoppered at 2 - 8° C. |
| Shelf Life | Not explicitly stated as acceptance criteria, but tested. | 2 years, when stored unopened at 2 - 8° C. (Real-time studies ongoing) |
| Linearity | The five levels demonstrate a linear relationship to each other for Ammonia and Ethanol analytes. | The device's intended use statement claims the five levels demonstrate a linear relationship. The study "retained on file at Aalto Scientific, Ltd." would presumably show this. |
| Equivalence to Predicate | "Substantially equivalent to the predicate device" (Microgenics Document Ammonia/Ethanol CAL•VER® K944338) | The conclusion states: "Based upon the purpose of the device, the descriptions and labeling of the predicate device, the safety and efficacy, and the stability data generated, the product is substantially equivalent to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not explicitly detail the sample size or provenance (country of origin, retrospective/prospective) of the data used for the performance studies. It simply states, "Stability studies have been performed to determine stability and shelf life for the Audit™ MicroCV™ Ammonia/Ethanol Linearity Set. All supporting data is retained on file at Aalto Scientific, Ltd." and refers to "stability data generated" for the substantial equivalence conclusion.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Given that this is a linearity and stability test for an in vitro diagnostic quality control material, the concept of "experts establishing ground truth" in the common sense of clinical image review or diagnostic interpretation does not apply directly. The ground truth for this device would be established by:
- Analytical measurements: Precise laboratory equipment and reference methods would be used to determine the actual concentrations of Ammonia and Ethanol at each level.
- Time-point measurements: For stability studies, measurements would be taken at various time points to assess degradation or changes over time.
Therefore, no "experts" in the sense of clinicians or radiologists are involved in establishing ground truth for this type of device. The expertise lies in the analytical chemists and laboratory personnel conducting the tests according to validated protocols.
4. Adjudication Method for the Test Set
Again, the concept of an adjudication method (like 2+1, 3+1 for clinical consensus) does not apply to the analytical performance testing described for this device. The assessment of linearity and stability would involve:
- Statistical analysis: Determining if the measured concentrations across the five levels indeed show a linear relationship using statistical methods (e.g., linear regression, acceptable deviation from linearity).
- Comparison to predefined limits: For stability, measured concentrations at different time points would be compared to initial concentrations or predefined stability specifications.
No human adjudication panel is necessary for these types of objective quantitative measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done for this device. This type of study is typically used for diagnostic devices that involve human interpretation (e.g., radiology AI tools to assess reader performance). The Audit™ MicroCV™ Ammonia/Ethanol Linearity Set is an in vitro diagnostic quality control material, not a device interpreted by human readers for diagnostic purposes.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, the concept of a "standalone algorithm" is not applicable to this device. This device is a physical reagent set used to verify the performance of analytical chemistry systems (analyzers). It is not an algorithm, nor does it operate as a standalone diagnostic tool without human interaction (as it requires human setup and operation within a laboratory).
7. The Type of Ground Truth Used
The ground truth used for verifying the performance of this device would be:
- Analytical Reference Values: Established concentrations of Ammonia and Ethanol in the linearity set, ideally traceable to recognized reference materials or methods.
- Stability Specifications: Predetermined acceptable limits of variation from the initial reference values over time under specified storage conditions.
It relies on precise chemical measurements and validated laboratory procedures, not expert consensus, pathology, or direct outcomes data in the clinical sense.
8. The Sample Size for the Training Set
This device is not an AI/ML algorithm, so the concept of a "training set" does not apply. The manufacturer develops the product, then tests its analytical performance (linearity, stability).
9. How the Ground Truth for the Training Set Was Established
As stated above, there is no training set for this type of in vitro diagnostic quality control material.
§ 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.