(43 days)
The Audit™ MicroCV™ Tumor Markers Linearity Set is intended to simulate human patient serum samples for the purpose of verifying and validating the Analytical Measurement Range for non-waived turnor marker testing methods as identified in the package insert.
The Audit™ MicroCV™ Tumor Markers Linearity Set consists of five levels in Human based serum. Each level contains the following analytes: Alpha fetoprotein (AFP), Carcinoembryonic antigen (CEA), CA 125, CA 15-3, Prostate specific antigen-free (free PSA), total PSA. 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.
The Audit™ MicroCVTM Tumor Markers Linearity Set 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 Tumor Marker 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.
This document is a 510(k) summary for the Audit™ MicroCV™ Tumor Markers Linearity Set, a quality control material. It describes the device, its intended use, and claims substantial equivalence to another legally marketed device. However, it does not contain the detailed study information typically found in a clinical study report that would address many of the questions asked.
Based on the provided text, here is the information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance Statement |
|---|---|
| Reconstituted Stability Analyte Stability | All analytes stable for 7 days when stored tightly capped at 2 - 8° C. |
| Shelf Life (Unopened) | Two years, when stored unopened at 2 - 8° C. |
| Linearity Relationship between 5 levels | The five levels demonstrate a linear relationship to each other for their respective analytes, reagents, and instruments. (This is an indication of use/claim, not detailed performance data found in this summary). |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified. The document states "Stability studies have been performed to determine the reconstituted stability and shelf life for the Audit™ MicroCV™ Tumor Markers Linearity Set. All supporting data is retained on file at Aalto Scientific, Ltd." It does not provide details of the sample size used in these studies.
- Data Provenance: Not specified. It's implied the studies were conducted by Aalto Scientific, Ltd. but no information on country of origin or whether the data was retrospective or prospective is given, other than "Real time studies are ongoing to support the shelf life of this product," which implies prospective data collection for shelf life.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not applicable. This device is a linearity set for quality control of analytical instruments, not a diagnostic device requiring expert interpretation of results to establish ground truth for a test set. The "ground truth" here would relate to the known concentrations or linearity of the materials themselves, which are manufactured to specific specifications.
- Qualifications of experts: Not applicable.
4. Adjudication method for the test set
- Adjudication method: Not applicable. This is not a study that involves human interpretation of results requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- MRMC study: No. This is not a diagnostic device that would typically involve an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone performance: Not applicable. This is a linearity quality control material, not an algorithm or software. The "performance" relates to the stability and linearity characteristics of the material itself.
7. The type of ground truth used
- Type of ground truth: The "ground truth" for this linearity set would be the pre-defined, manufactured concentrations of the analytes at each of the five levels, and the expected linear relationship between these levels. These values are established during the manufacturing and characterization process of the QC material against reference methods or calibrators. The document states it is "human based," referring to the serum matrix, but not to human interpretation as ground truth.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This device is a quality control material and does not use a "training set" in the context of machine learning or classification algorithms.
9. How the ground truth for the training set was established
- Ground truth for training set: Not applicable (as above).
§ 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.