(38 days)
The Audit™ MicroCV™ Immunoassay Linearity Set consists of five levels in Human and Bovine serum albumin matrix. Each level contains the following analytes: Cortisol, Digoxin, Estradiol, Ferritin, Folate, Free T4, FSH, hCG, LH, Progesterone, Prolactin, Testosterone, Total PSA, Total T3, Total T4, TSH, and Vitamin B12. The five levels demonstrate a linear relationship to each other for their respective analytes, reagents, and instruments.
This product 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™ Immunoassay Linearity Set is a Human and Bovine serum albumin based, lyophilized, five level set of QC material, with each level containing 17 analytes It is used for proficiency testing in interlaboratory surveys and to perform CLIA directed calibration verification for the analytes listed using FDA accepted reagents for the appropriate instrumentation in accordance with current CLIA-88 guidelines and regulations. In apdrtions Level A ~ E of this product may be used as an unassayed quality control material for these analytes or as an assayed quality control material for the analyzer systems specified in the package insert. Where Level A is near the lower limit of instruments 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. It is not intended to be used as an assayed quality control material for any other analyzer systems.
The provided text describes the Audit™ MicroCV™ Immunoassay Linearity Set, a QC material used for verifying and validating the analytical measurement range for immunoassay testing methods. The information focuses on establishing substantial equivalence to a predicate device and product claims related to stability. It does not present acceptance criteria or detailed results of a study designed to prove the device meets specific performance criteria related to accuracy, precision, or comparison against a ground truth.
However, it does describe the stability studies performed, which can be interpreted as a form of performance evaluation for the claims made.
Here's an analysis based on the provided text, addressing the points where information is available and noting where it's absent:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria for performance beyond stability. The "reported device performance" is limited to stability claims.
| Acceptance Criteria (Implicit from Study) | Reported Device Performance |
|---|---|
| Reconstituted Stability should meet claim | 5 days at 2-8° C |
| Shelf Life should meet claim | 2 years, unopened at 2-8° C |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "stability studies have been performed," but does not detail the number of samples, batches, or replicates used in these studies.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): "All supporting data is retained on file at Aalto Scientific, Ltd." This implies the studies were conducted by the manufacturer, Aalto Scientific, Ltd., likely in the USA (where the company is based). The studies were prospective in nature, as they were conducted to support product claims for a new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The study described is a stability study of the QC material itself, not a study evaluating diagnostic accuracy against patient samples or clinical outcomes. Therefore, there's no "ground truth" in the sense of expert-validated patient diagnoses.
4. Adjudication Method for the Test Set
Not applicable, as there is no diagnostic outcome being adjudicated.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This is a linearity set (QC material) for laboratory instruments, not an AI diagnostic device. Therefore, no MRMC study comparing human readers with or without AI assistance was conducted or would be applicable.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
Not applicable. This is a laboratory quality control material, not an algorithm or AI device.
7. The Type of Ground Truth Used
The "ground truth" in the context of stability studies for a linearity set refers to the expected stability profile of the analytes under specified conditions. This is established through internal testing and adherence to scientific principles of chemical and biochemical stability. For a linearity set, the "ground truth" would also refer to the accurate concentration assignment of the levels, which is done through a robust internal assay and manufacturing process, but this part of the study is not detailed.
8. The Sample Size for the Training Set
Not applicable. This is a quality control material, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
Summary of Device and Performance Information Provided:
The primary purpose of the document is to demonstrate substantial equivalence to a predicate device (Audit™ MicroCV™ General Chemistry Linearity Set, K042318) for regulatory approval (510(k)). The performance data presented focuses exclusively on the stability of the device:
- Device Name: Audit™ MicroCV™ Immunoassay Linearity Set
- Intended Use: To simulate human patient serum samples for verifying and validating the Analytical Measurement Range for non-waived immunoassay testing methods. Can also be used for proficiency testing and as unassayed/assayed quality control material.
- Key Performance Claims (from Stability Studies):
- Reconstituted Stability: 5 days when stored tightly capped at 2-8° C.
- Shelf Life: 2 years, when stored unopened at 2-8° C. (Note: Real-time studies are ongoing to support this claim).
- Matrix: Human and Bovine serum albumin based.
- Levels: Five levels (A-E) of lyophilized QC material, each containing 17 analytes (Cortisol, Digoxin, Estradiol, Ferritin, Folate, Free T4, FSH, hCG, LH, Progesterone, Prolactin, Testosterone, Total PSA, Total T3, Total T4, TSH, and Vitamin B12).
The document is a regulatory summary and, as such, focuses on demonstrating compliance and equivalence rather than a detailed scientific publication about a novel AI or diagnostic algorithm performance.
§ 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.