(18 days)
Free PSA MasterCheck is intended for use in the verification of sensitivity, calibration linearity and reportable range of the Free PSA assay on the Abbott ARCHITECT System.
Total PSA MasterCheck is intended for use in the verification of sensitivity, calibration linearity and reportable range of the Total PSA assay on the Abbott ARCHITECT i System.
These are liquid products prepared from HEPES buffer with protein (bovine), constituents of human origin, stabilizers and preservatives. (Level 0 does not contain preservatives or constituents of human origin).
This document describes the Architect Free PSA MasterCheck and Architect Total PSA MasterCheck, which are quality control materials. The information provided does not pertain to an AI/ML device, a diagnostic device that requires ground truth from experts, or a device that would necessitate a multi-reader multi-case study. Therefore, the requested information regarding acceptance criteria and study details as they relate to AI/ML or diagnostic performance is not applicable or cannot be extracted from this document.
However, I can extract information related to the device's stability and its intended use as a quality control material.
Device Description:
The Architect Free PSA MasterCheck and Architect Total PSA MasterCheck are liquid products prepared from HEPES buffer with bovine protein, constituents of human origin, stabilizers, and preservatives. They are intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Free PSA assay and Total PSA assay, respectively, on the Abbott ARCHITECT System.
Acceptance Criteria and Device Performance (Stability Studies):
The document provides information on stability studies, which serve as a form of performance criteria for these quality control materials.
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Open Vial Stability | 3 days when stored tightly capped at 2°C to 8°C | 3 days when stored tightly capped at 2°C to 8°C |
| Shelf Life (Unopened) | 12 months when stored at 2°C to 8°C | 12 months when stored at 2°C to 8°C |
Other Requested Information (Not Applicable or Not Provided for this Device Type):
- Sample sized used for the test set and the data provenance: Not applicable as this is a quality control material and not a diagnostic device with a clinical "test set" in the context of patient data. The stability studies likely involved samples of the control material itself, but the specific number of units or batches tested is not detailed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic performance is not relevant for a quality control material.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not applicable for a quality control material.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, this is not applicable as the device is not an algorithm.
- The type of ground truth used: Not applicable, as the "ground truth" for a quality control material relates to its inherent stability and accurate concentration, which is verified through laboratory testing.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
This document focuses on the regulatory submission for the quality control material, primarily demonstrating its substantial equivalence to a predicate device and its stability. It does not contain information typically associated with the evaluation of AI/ML or diagnostic devices using patient data.
§ 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.