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510(k) Data Aggregation
(182 days)
The FastPack™ PSA Immunoassay is a paramagnetic particle, chemiluminescence immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum. The FastPack™ PSA Immunoassay is indicated as an aid in the management of patients with prostate cancer. The FastPack™ PSA Immunoassay is designed for use with the FastPack™ Analyzer System.
The FastPack™ PSA Immunoassay is a two-site chemiluminescence assay. The FastPack™ Analyzer System is a compact chemiluminuescent immuoassay system consisting of four components: FastPack™ (Reagent Pack), FastPack™ Sample Filler, FastPack™ Analyzer, and Pressure/Power Supply. The FastPack™ is a small plastic package containing pre-measured reagents. The FastPack™ Sample Filler delivers a quantified sample. The FastPack™ Analyzer performs the assay by automatically mixing and moving the sample and reagents within the pack using pressure pads and a magnet. Temperature control is achieved by heating metal plates.
Here's an analysis of the provided text, outlining the acceptance criteria and study details for the FastPack™ PSA Immunoassay:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a formal table format with pass/fail thresholds. However, it presents the "Performance Characteristics" of the FastPack™ PSA against the predicate device (Abbott IMx® PSA). We can infer that the comparable performance to the predicate device serves as an implicit acceptance criterion for substantial equivalence.
| Feature | Implicit Acceptance Criteria (Comparable to Predicate Device) | FastPack™ PSA Performance Reported |
|---|---|---|
| Precision (Between Run) | Should be comparable to Abbott IMx® PSA Intra-assay | Low (0.75 ng/mL): 13.1% |
| Med (2.94 ng/mL): 11.2% | ||
| High (23.41 ng/mL): 9.4% | ||
| Precision (Between Analyzer) | Should be comparable to Abbott IMx® PSA Inter-assay | Low (0.75 ng/mL): 6.2% |
| Med (2.94 ng/mL): 3.7% | ||
| High (23.41 ng/mL): 1.1% | ||
| Precision (Between Reagent Lot) | Not directly comparable to predicate's reported Inter-assay categories, but low variability is expected. | Low (0.75 ng/mL): 1.7% |
| Med (2.94 ng/mL): 5.0% | ||
| High (23.41 ng/mL): 1.4% | ||
| Analytical Sensitivity | Should be comparable to or better than Abbott IMx® PSA | 0.04 ng PSA/mL |
| Spike Recovery | Should be comparable to Abbott IMx® PSA | 96 to 107% |
| Dilution Recovery | Not explicitly stated for predicate; demonstrating recovery is an expectation. | 94 to 120% |
| Method Comparison | Strong correlation (high r²) and agreement (slope close to 1, intercept close to 0) with Abbott IMx® PSA. | n = 110 |
| Range (Abbott): 0 to 51.6 ng PSA/mL | ||
| Range (FastPack): 0 to 57.0 ng PSA/mL | ||
| y = 0.971x - 0.2367 (Deming) | ||
| r² = 0.984 (Spearman) | ||
| s²_slope = 0.000403 | ||
| s²_intercept = 0.111306 | ||
| Interfering Substances | No significant interference at or above levels comparable to predicate. | Bilirubin: No interference up to 49 mg/dL (better than predicate) |
| Hemoglobin: 600 mg/dL | ||
| IgG: 1900 mg/dL | ||
| PAP: 1000 ng/mL | ||
| HAS: Interference found at 3 g/dL | ||
| Triglycerides: 3000 mg/dL | ||
| Cyclophosphamide: 700 µg/mL | ||
| DES: 1 µg/mL | ||
| Doxorubicin HCl: 16 µg/mL | ||
| Methotrexate: 8 µg/mL | ||
| Megestrol Acetate: 90 µg/mL | ||
| Flutamide: 10 µg/mL | ||
| Lupron: 100 µg/mL | ||
| High Dose Hook Effect | Absence of hook effect up to clinically relevant concentrations. | No high dose hook effect up to 500 ng/mL |
2. Sample Size Used for the Test Set and Data Provenance
For the Method Comparison study (which serves as a key test set for comparing with the predicate):
- Sample Size: n = 110 samples.
- Data Provenance: The document does not specify the country of origin. It also does not explicitly state if the data was retrospective or prospective, but clinical method comparison studies typically use prospectively collected or banked samples representing real-world conditions.
For Precision studies, specific sample sizes beyond the general levels (low, medium, high) are not detailed. Similarly for Interfering Substances, specific sample sizes per substance are not given.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For an immunoassay like this, the "ground truth" for the test set (e.g., the PSA values) would typically be established by the predicate device's measurement or a reference method. No human experts are involved in establishing the "ground truth" for a quantitative analyte measurement itself, as it's a direct biochemical measurement.
4. Adjudication Method for the Test Set
This concept is not applicable to this type of device (quantitative immunoassay). Adjudication usually pertains to subjective assessments, like medical imaging interpretations, where different human readers might have varying opinions that need to be reconciled. For an immunoassay, the "truth" is the measured analyte concentration.
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
This is not applicable. The FastPack™ PSA Immunoassay is a standalone in vitro diagnostic device for quantitative PSA measurement, not an AI-powered image analysis tool or a system involving human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies presented are standalone performance evaluations of the FastPack™ PSA Immunoassay and Analyzer System. The performance characteristics (precision, sensitivity, recovery, method comparison, interference) are measured solely based on the device's output. There is no human interpretation or intervention in the measurement process itself, beyond sample preparation and loading.
7. The Type of Ground Truth Used
For the method comparison study, the Abbott IMx® PSA measurements were used as the reference or "ground truth" for comparison. This is a common practice in 510(k) submissions where a new device is compared to a legally marketed predicate device. For the other performance metrics (precision, sensitivity, recovery, interference, hook effect), the "ground truth" is established by calibrated control materials or spiked samples with known concentrations.
8. The Sample Size for the Training Set
This information is not provided. Immunoassays like this typically do not have a "training set" in the machine learning sense. Instead, they involve extensive R&D and optimization of reagents, reaction conditions, and calibration algorithms, which would use numerous samples, but these are not usually referred to as a "training set" in the context of regulatory submissions for in vitro diagnostics. If any statistical models were used in the instrument's software, the data used to develop those models would be analogous to a training set, but specifics are absent here.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, a "training set" as understood in AI/ML is not explicitly part of this submission. The development and optimization of the assay would involve using well-characterized samples, calibrators, and controls with known PSA concentrations, likely established through a combination of gravimetric/volumetric preparation, reference methods, and validation against established standards.
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(164 days)
The Qualisys PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum. The Qualisys PSA Immunoassay is further indicated for the serial measurement of PSA as an aid in the prognosis and management of patients with prostate cancer.
The Qualisys PSA Immunoassay is a two-site chemiluminescense assay. 1st incubation: 15 minutes at room temperature. Specimen, control or calibrator [100 µL] and PSA Antibody Solution [100 µL] react to form a sandwich complex. 2nd incubation: 2 minutes at room temperature. Streptavidin-coated paramagnetic particle solution [25 µL] is added to the reaction mixture. After the 2-minute incubation, the sandwich complex is bound to the solid-phase via the interaction of biotin and streptavidin. Removal of unbound materials: The paramagnetic particles are washed four times with wash buffer [1.0 mL/wash] to remove unbound materials. Re-suspension of paramagnetic particles: Deionized (DI) water [25 uL] is added to re-suspend the washed paramagnetic particles. Substrate addition and detection: Chemiluminogenic substrate [50 uL] is added to the solid-phase bound complex and results in "glow" chemiluminescence, which is measured using a luminometer (photomultiplier). Emission of light is quantified for 1 second, and is expressed in relative light units (RLU). The amount of bound labeled antibody in RLU's is directly proportional to the concentration of PSA in the sample. Results are determined using cubic spline immunoassay curve fitting.
The Qualisys PSA Immunoassay is a device designed for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum, specifically for the serial measurement of PSA to aid in the prognosis and management of patients with prostate cancer.
Here's an analysis of its acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a go/no-go fashion. Instead, it presents performance characteristics for the Qualisys PSA Immunoassay and compares them to the predicate device, Abbott IMx® PSA. For the purpose of this response, the performance characteristics of the Qualisys PSA are considered the reported device performance, and the comparison to the predicate implies that similar or improved performance is an acceptance benchmark for substantial equivalence.
| Feature | Predicate Device (Abbott IMx® PSA) Performance | Qualisys PSA Immunoassay Reported Performance |
|---|---|---|
| Precision | ||
| Intra-assay: Low | 3.5% (at 4.6 ng/mL) | 3.4% (at 0.52 ng/mL) |
| Intra-assay: Med | 3.3% (at 15.6 ng/mL) | 1.7% (at 3.05 ng/mL) |
| Intra-assay: High | 3.1% (at 60.2 ng/mL) | 3.0% (at 23.06 ng/mL) |
| Inter-assay: Low | 4.7% (at 4.6 ng/mL) | 5.7% (at 0.52 ng/mL) |
| Inter-assay: Med | 4.5% (at 15.6 ng/mL) | 2.6% (at 3.05 ng/mL) |
| Inter-assay: High | 5.3% (at 60.2 ng/mL) | 3.7% (at 23.06 ng/mL) |
| Analytical Sensitivity | 0.1 ng PSA/mL | 0.003 ng PSA/mL |
| Functional Sensitivity | Not reported | 0.1 ng PSA/mL |
| Spike Recovery | 91 to 103% | 90 to 110% |
| Dilution Recovery | Not reported | 92 to 108% |
| Method Comparison | (Reference device for comparison) | y = 0.9955x + 0.5185 (r² = 0.9747) vs Abbott IMx® PSA |
| Interfering Substances | No interference up to specific concentrations | Similar or improved interference thresholds |
| High Dose Hook Effect | Not reported | No high dose hook effect up to 1250 ng/mL |
Note: The specific PSA concentrations for the Qualisys precision targets differ from the predicate, making direct percentage comparison difficult without further context on the clinical relevance of those specific concentrations. However, the percentages themselves are in a similar range, indicating comparable precision.
2. Sample Size Used for the Test Set and Data Provenance
- Method Comparison Study: The test set for the method comparison study consisted of n = 108 samples.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given the nature of a 510(k) submission, it's highly likely to be prospective study data collected to demonstrate device performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This device is an immunoassay for quantitative determination of PSA levels, not an imaging or interpretive device that requires expert review for ground truth. The "ground truth" for the test set in this context refers to the actual PSA concentrations in the samples, which were implicitly determined by the predicate device (Abbott IMx® PSA) that the Qualisys device is being compared against, or by a reference method. The document does not mention experts establishing ground truth in the way described for interpretive medical devices.
4. Adjudication Method for the Test Set
Not applicable. As this is a quantitative immunoassay, there would be no subjective interpretation requiring an adjudication method. The method comparison involves comparing numerical results obtained by the test device against the predicate device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for interpretive tasks where multiple readers evaluate cases. This device is a quantitative immunoassay and does not involve human "readers" in the performance assessment in the context of an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance characteristics listed (precision, sensitivity, recovery, method comparison, interference, hook effect) are all standalone performance metrics of the Qualisys PSA Immunoassay device itself, independent of human interpretation or intervention beyond performing the assay procedure.
7. The Type of Ground Truth Used
The ground truth for the method comparison study was established by the Abbott IMx® PSA device. The predicate device's measurements served as the reference against which the Qualisys PSA Immunoassay's measurements were compared (y = 0.9955x + 0.5185, r² = 0.9747). For other performance characteristics like precision, sensitivity, and recovery, the "ground truth" refers to the known concentrations of analytes in control samples or spiked samples.
8. The Sample Size for the Training Set
The document does not provide information on a "training set" or sample sizes used for training. Immunoassays are typically developed and validated rather than "trained" in the machine learning sense. The performance characteristics described are related to the analytical validation of the device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, immunoassays typically undergo analytical validation rather than machine learning training. Therefore, a "training set" and its associated ground truth establishment method are not relevant in this context.
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