(185 days)
The FastPack® Total PSA Method Verification Kit consists of assayed quality control materials for verification of the calibration and reportable range of the FastPack® Total PSA Immunoassay to meet CLIA requirements.
The FastPack® PSA Method Verification Kit The FastPack® Total PSA Method Verification kit components are in liquid form, in vials, from which the user can directly remove sample. They are formulated at three (3) levels packaged together as a kit.
The provided text is a 510(k) summary for the FastPack® Total PSA Method Verification Kit. It describes the device, its intended use, and compares it to a predicate device. However, this document does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in performance studies for diagnostic devices.
The document focuses on demonstrating substantial equivalence to a predicate device based on similar features and intended use. The "Method Verification Kit" itself is a quality control material used to verify the calibration and reportable range of another immunoassay (the FastPack® Total PSA Immunoassay), rather than a device that directly measures a patient's analyte. Therefore, the "performance" of this kit is assessed by its characteristics as a quality control material (e.g., PSA concentrations, matrix, form), not by diagnostic accuracy metrics.
Here's a breakdown of the requested information based on the provided text, with explicit statements where information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
No explicit acceptance criteria or a numerical performance table for the "FastPack® Total PSA Method Verification Kit" are provided in this document. The document states it is a "Method Verification Kit" and compares its features to a "Predicate Device" in a table. This comparison highlights attributes like intended use, analytes, matrix, form, volume, and levels of PSA concentrations. It does not present performance metrics against predefined acceptance criteria.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified for the Method Verification Kit's performance. | Not specified in terms of performance metrics. |
| Comparison to Predicate Device (Features): | |
| Intended Use | New Device: Assayed quality control materials for the verification of the calibration and reportable range of the FastPack® Total PSA Immunoassay to meet CLIA requirements. |
| Analytes | Total PSA |
| Matrix | Bovine Serum Albumin |
| Form | Liquid |
| Volume | 5.0 mL |
| Levels | 3 levels (0 ng/mL, 25 ng/mL, 50 ng/mL) |
2. Sample size used for the test set and the data provenance
- Sample size from the test set: Not applicable/Not provided. The kit itself is a quality control material, not a diagnostic test performed on patient samples.
- Data provenance: Not applicable/Not provided.
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/Not provided. This device is a quality control material, not a diagnostic device requiring expert interpretation of results.
- Qualifications of experts: Not applicable/Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable/None. This device is a quality control material.
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
- MRMC study: No. This device is a quality control material and not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance study: No. This device is a quality control material.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of ground truth: Not applicable/Not provided in the context of diagnostic accuracy. For the quality control material itself, the specified PSA concentrations (0 ng/mL, 25 ng/mL, 50 ng/mL) would serve as the "true" values for verifying the immunoassay. How these concentrations were established (e.g., gravimetric preparation against a standard) is not detailed in this document.
8. The sample size for the training set
- Training set sample size: Not applicable/Not provided. This document describes a quality control material, not a machine learning model.
9. How the ground truth for the training set was established
- Ground truth for training set: Not applicable/Not provided.
§ 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.