Search Results
Found 1 results
510(k) Data Aggregation
(338 days)
Premier Resolution System
The Premier Resolution System is an automated High Performance Liquid Chromatography (HPLC) system which performs the separation of hemoglobin species in venous whole blood samples for the quantitative analysis of normal hemoglobin (A, A2, and F), and the qualitative detection of major variant hemoglobin S, C, D-Los Angeles, and E in adult, adolescent, children and infant populations. The assays are performed on venous whole blood samples collected in tubes containing K2EDTA as anticoagulant.
The Premier Resolution System is intended for Professional Laboratory Use only.
The Premier Resolution System is intended for use with analytical components and reagents provided by Trinity Biotech.
The Premier Resolution System is intended to be used in conjunction with other laboratory and clinical findings.
For In Vitro Diagnostic Use.
The Premier Resolution System consists of a high performance liquid chromatographic analyzer, reagents, analytical column and software which allows for the fractionation and quantitation of fetal hemoglobin (Hb F), and hemoglobin A2 (Hb A2), and with fractionation and presumptive identification of abnormal hemoglobin variants. This is accomplished using the principles of ion-exchange (IEX) high performance liquid chromatography (HPLC).
This document describes the performance data for the "Premier Resolution System," an automated High Performance Liquid Chromatography (HPLC) system for hemoglobin analysis. The study aims to demonstrate that the device is substantially equivalent to a predicate device, the Bio-Rad Variant II ß-thalassemia (K991127).
1. Acceptance Criteria and Reported Device Performance:
The document outlines comparative performance against a predicate device (Bio-Rad Variant II ß-thalassemia) and precision studies. The acceptance criteria are implicitly defined by demonstrating comparability and acceptable precision, rather than explicit thresholds for each metric. The reported device performance includes:
| Acceptance Criteria (Implicit) | Reported Premier Resolution System Performance (Quick Scan Assay) | Reported Premier Resolution System Performance (High Resolution Assay) |
|---|---|---|
| Correlation (Method Comparison) - Mean Bias vs. Predicate (Bio-Rad Variant II) | ||
| HbF comparability | -0.3 bias (1.1 to 48.9% interval) with 160 patient results | -0.4 bias (1.1 to 46.6% interval) with 158 patient results |
| HbA comparability | 0.7 bias (2.5 to 89.7% interval) with 682 patient results | 2.4 bias (3.5 to 90.5% interval) with 586 patient results |
| HbA2 comparability | 0.1 bias (1.6 to 6.1% interval) with 602 patient results | 0.1 bias (1.6 to 6.0% interval) with 598 patient results |
| HbS comparability | 0.3 bias (6.8 to 67.1% interval) with 106 patient samples | 1.3 bias (1.9 to 67.9% interval) with 110 patient samples |
| HbC comparability | -1.1 bias (9.5 to 82.8% interval) with 49 patient results | -1.0 bias (10.2 to 82.5% interval) with 49 patient results |
| HbD-LA comparability | 1.6 bias (11.6 to 82.7% interval) with 17 patient results | 2.7 bias (11.7 to 84.1% interval) with 17 patient results |
| HbE comparability | -3.0 bias (5.5 to 70.4% interval) with 25 patient results | -4.9 bias (5.3 to 66.7% interval) with 25 patient results |
| Precision (Single Site) - Within-Laboratory %CV | ||
| HbA (High) | 3.61% | 3.63% |
| HbA (Mid) | 0.89% | 1.37% |
| HbA2 (Mid) | 2.23% | 7.22% |
| HbA2 (Low) | 5.99% | 7.15% |
| HbF (High) | 1.05% | 3.49% |
| HbF (Mid) | 3.26% | 9.10% |
| HbS (High) | 0.89% | 1.33% |
| HbS (Mid) | 0.98% | 1.69% |
| HbC (High) | 0.78% | 1.15% |
| HbC (Mid) | 1.75% | 2.03% |
| HbD (High) | 1.88% | 2.20% |
| HbD (Mid) | 2.04% | 1.32% |
| HbE (High) | 2.84% | 4.63% |
| HbE (Mid) | 3.06% | 3.14% |
| LoD/LoQ (Quick Scan) | ||
| HbF LoD | 0.2% | 0.1% |
| HbF LoQ | 1.1% | 1.1% |
| HbA LoD | 0.1% | 0.7% |
| HbA LoQ | 2.3% | 2.2% |
| HbA2 LoD | 0.1% | 0.2% |
| HbA2 LoQ | 1.5% | 1.5% |
| HbS LoD | 0.1% | 0.3% |
| HbS LoQ | 1.0% | 0.9% |
| HbC LoD | 0.1% | 0.3% |
| HbC LoQ | 1.0% | 1.7% |
| HbD-LA LoD | 0.1% | 0.1% |
| HbD-LA LoQ | 1.5% | 1.4% |
| HbE LoD | 0.1% | 0.6% |
| HbE LoQ | 1.5% | 2.7% |
2. Sample Size and Data Provenance (Test Set):
- Correlation (Method Comparison): A total of 780 unique patient samples were collected and analyzed. The data provenance is described as being collected and analyzed at three (3) professional external laboratory sites. It is implicit that these were retrospective real-world samples, as they are referred to as "patient samples" used for method comparison against an existing device. The country of origin is not explicitly stated, but given the FDA submission, it is likely the US.
- Precision (Single Site): The sample size for each analyte was 80 data points, generated by a 20x2x2 study design over 20 days, with two runs per day and two replicates per run. These were "samples of varying concentrations" and not explicitly patient samples.
- Precision (Multisite): The sample size for each analyte was 75 data points (3x5x5 study design across three external sites, over five days with five replicates per day). These were "precision samples."
- Limits of Detection: 60 determinations of low-level samples for each hemoglobin type. These were "human whole blood samples" with varying levels of hemoglobins.
3. Number of Experts and Qualifications for Ground Truth (Test Set):
This device is an in-vitro diagnostic (IVD) instrument for quantitative and qualitative analysis of hemoglobin species. The ground truth for such devices is typically established by well-characterized reference methods or by comparison to a legally marketed predicate device. In this submission, the primary method for establishing the device's performance is:
- Correlation (Method Comparison): Comparison against the Bio-Rad Variant II ß-thalassemia, which serves as the "ground truth" or reference for establishing substantial equivalence. No human experts are described as establishing ground truth for the test set, as the ground truth is the measurement from the predicate device.
4. Adjudication Method for the Test Set:
Not applicable. The study design involves direct comparison of quantitative measurements from two analytical instruments (device under review vs. predicate device), and precision of the device itself. There is no subjective interpretation requiring adjudication by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is an in-vitro diagnostic device that provides quantitative and qualitative measurements, not an image-based diagnostic system requiring human interpretation with or without AI assistance. Therefore, an MRMC study is not relevant.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop):
Yes, the entire study focuses on the standalone performance of the "Premier Resolution System" as an automated HPLC system. There is no human-in-the-loop component described for its routine operation or for the performance studies presented. The device performs the analysis and provides results independently.
7. Type of Ground Truth Used:
The ground truth for the device's performance is established mainly through:
- Comparison to a legally marketed predicate device: The Bio-Rad Variant II ß-thalassemia, for method comparison (correlation).
- Internal consistency and statistical measures: For precision (repeatability, within-laboratory, reproducibility) and limits of detection/quantitation. This relies on the inherent analytical capabilities and controls of the new device itself.
8. Sample Size for the Training Set:
The document does not explicitly describe a "training set" in the context of machine learning or AI models. This device is an automated HPLC system, where performance is based on chemical separation principles, not a learning algorithm that requires a separate training phase with labeled data in the AI sense. Its "training" or development would involve chemical and engineering optimization.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no mention of a "training set" in the context of an AI/ML model for this device. The development of an HPLC system involves instrument design, reagent formulation, and software development, which are validated through analytical performance studies like those presented (precision, linearity, method comparison, etc.).
Ask a specific question about this device
Page 1 of 1