(48 days)
The Audit™ MicroCV™ Lipids Linearity Set (Low) consists of five levels. Each level contains the following analytes: Apolipoprotein A1, Apolipoprotein B, Cholesterol, HDL Cholesterol. LDL Cholesterol and Triglyceride and may be used for proficiency testing in interlaboratory surveys and to perform CLIA directed calibration verification for these same analytes with similar reagents on similar instrumentation in accordance with current CLIA-88 guidelines and regulations.
In addition, Level A - E of this product may be used as unassayed quality control material for these analytes or as an assayed quality control material for the analyzer systems specified in the package insert. It is not intended to be used as an assayed quality control material for any other analyzer systems.
The Audit™ MicroCV™ Lipids Linearity Set (Low) is a human based, lyophilized, five level set of QC material, with each level containing 6 analytes. It is used to confirm the proper calibration, linear operating range, and reportable range of Lipids methods for 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 Audit™ MicroCV™ Lipids Linearity Set (Low) is a quality control material used to verify and validate the Analytical Measurement Range for non-waived Lipids testing methods.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Reconstituted Stability | 24 hours when stored tightly capped at 2 - 8° C. |
| Shelf Life | Two years, when stored unopened at 2 - 8° C. |
| Substantial Equivalence | Deemed substantially equivalent to predicate device. |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document does not explicitly state the sample size used for the stability studies. It only mentions that "All supporting data is retained on file at Aalto Scientific, Ltd." The data provenance is internal to Aalto Scientific, Ltd. and the studies are described as "real time studies" which implies a prospective nature for shelf life, while reconstituted stability would also be prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided. The study focuses on product stability and equivalence to a predicate device, rather than diagnostic accuracy requiring expert consensus on a test set.
4. Adjudication Method for the Test Set:
Not applicable. The study design does not involve adjudication of results by multiple experts as it is focused on the chemical stability and performance characteristics of a quality control material.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This type of study is relevant for diagnostic devices that involve human interpretation of results. The Audit™ MicroCV™ Lipids Linearity Set (Low) is a quality control material.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance):
This concept is not directly applicable. The device itself is a quality control material, not an algorithm. Its performance is measured by its stability and ability to perform as a linearity set, which is an inherent characteristic of the material. The studies performed are to establish these inherent characteristics.
7. Type of Ground Truth Used:
The ground truth for the stability studies is implied to be the direct measurement of analyte concentrations over time under specified storage conditions. For the substantial equivalence claim, the ground truth is the established performance and characteristics of the predicate device (Audit™ MicroCV™ General Chemistry Linearity Set K042318).
8. Sample Size for the Training Set:
Not applicable. The product is a quality control material, not a machine learning algorithm that requires a training set. The "study" mentioned refers to stability testing, not algorithm training.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of product. The ground truth for the stability studies would be established through standard analytical laboratory procedures, measuring the chemical composition of the control material over time.
§ 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.