(58 days)
The Access Hybritech p2PSA QC are tri-level controls intended for monitoring system performance of immunoenzymatic procedures for the quantitative measurement of [-2]proPSA isoform of Prostate Specific Antigen (PSA) using the Access Immunoassay Systems.
The Access Hybritech p2PSA OC are tri-level controls intended for monitoring system performance of immunoenzymatic procedures for the quantitative measurement of [-2]proPSA isoform of Prostate Specific Antigen (PSA) using the Access Immunoassay Systems. The Access Hybritech p2PSA QC kit contains 3 X 5.0 mL bottles, one for each of the three control levels. The Access Immunoassay Systems utilize a "sandwich" immunoenzymatic method for quantitative analyte measurement.
This document is a 510(k) summary for the Access Hybritech p2PSA QC, a quality control material intended for monitoring the performance of immunoenzymatic procedures for measuring [-2]proPSA isoform of Prostate Specific Antigen (PSA) using the Access Immunoassay Systems. As such, the information provided focuses on demonstrating substantial equivalence to a predicate device rather than a study proving clinical diagnostic performance against acceptance criteria in the typical sense of a diagnostic medical device.
Therefore, the following answers are tailored to the nature of this submission for a quality control material.
1. Table of Acceptance Criteria and Reported Device Performance
For quality control materials, acceptance criteria typically relate to manufacturing specifications, stability, and reproducibility, ensuring the control itself performs consistently and within expected ranges, rather than diagnostic accuracy against a disease state. The document states: "Based on the results of the product performance characteristics testing, these controls meet product claims and specifications." However, specific numerical acceptance criteria and reported performance values are not detailed in this 510(k) summary. The summary focuses on comparing the new device to a predicate device and asserting that the new device meets specifications, without providing the specific data.
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly stated in this summary) | Reported Device Performance (Summary statement) |
|---|---|---|
| Manufacturing/Product Claims | Consistency across lots, stability (shelf-life), defined control ranges, matrix compatibility, instrument compatibility | "these controls meet product claims and specifications." |
| Reproducibility/Precision | (e.g., Coefficient of Variation % within acceptable limits across runs/instruments) | Not specified, but implied by meeting "product performance characteristics." |
| Stability | (e.g., analyte concentrations remain within specified ranges over shelf-life and in-use period) | "Shelf life: 12 months" (matches predicate), implies stability over this period. "Storage temperature after opening: 2 - 10°C" (matches predicate), implies stability under these conditions. |
2. Sample Size Used for the Test Set and Data Provenance
This is not a study evaluating diagnostic performance on patient samples. Instead, it concerns the performance of a quality control material.
- Sample Size for Test Set: Not applicable in the context of patient data. The "test sets" would be batches or lots of the quality control material itself, evaluated for their consistency and performance on the Access Immunoassay Systems. The number of such lots or runs used for testing is not specified in this summary.
- Data Provenance: Not applicable in the context of patient data origin. The testing would be performed internally by Beckman Coulter, Inc. in a laboratory setting. The data presented is from "product performance characteristics testing," which generally implies internal validation studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. For a quality control material, the "ground truth" is typically established by the manufacturer through rigorous analytical characterization of the control material's components and concentration. It does not involve human expert interpretation of clinical data.
4. Adjudication Method for the Test Set
Not applicable. As described above, the "test set" here refers to the quality control material itself and its performance characteristics, not clinical cases requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
Not applicable. An MRMC study is designed to evaluate the diagnostic performance of a system (human readers, with or without AI assistance) on clinical cases. This submission is for a quality control material, not a diagnostic device or an AI application intended to assist human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a quality control material, not an algorithm. Its function is to monitor the performance of an immunoenzymatic assay system, which itself reports quantitative measurements.
7. The Type of Ground Truth Used
The "ground truth" for a quality control material is its precisely characterized analyte concentration, stability properties, and matrix composition. This "ground truth" is established through analytical methods and manufacturing processes according to defined specifications, not by expert consensus, pathology, or outcomes data in the clinical sense. The document states that "Final concentrations are determined by value assignment using the Access Immunoassay Systems," indicating that the "ground truth" (assigned value) of the control itself is determined by the system it's designed to monitor, in a calibrated manner.
8. The Sample Size for the Training Set
Not applicable. This is for a quality control material, not an AI or 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 device.
§ 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.