Search Results
Found 1 results
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.
Ask a specific question about this device
Page 1 of 1