(90 days)
The Access EPO assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of erythropoietin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This assay is intended as an aid in the diagnosis of anemias and polycythemias.
The Access EPO assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of erythropoietin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This assay is intended as an aid in the diagnosis of anemias and polycythemias.
The Access EPO Calibrators are intended to calibrate the Access EPO assay for the quantitative determination of EPO levels in human serum and plasma (heparin) using the Access Immunoassay Systems.
The Access EPO assay is a two-site immunoenzymatic ("sandwich") assay. A sample is added to a reaction vessel along with the paramagnetic particles coated with mouse monoclonal anti-EPO, blocking reagent and the alkaline phosphatase conjugate. After incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the chemiluminescent substrate is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of analyte in the sample. Analyte concentration is automatically determined from a stored calibration.
The provided text describes the 510(k) premarket notification for the Beckman Coulter "Access EPO" assay when run on the Dxl 9000 Access Immunoassay Analyzer. This document outlines the device's technical characteristics, its intended use, and comparative studies against a predicate device. However, it does not describe an AI-powered diagnostic device or a study involving human readers and AI assistance. Instead, it describes an immunoassay for measuring erythropoietin levels. Therefore, many of the detailed points requested in your prompt (e.g., number of experts for ground truth, MRMC study, effect size of AI, standalone AI performance) are not applicable to this specific submission.
Despite this, I will extract and present the available information that aligns with your request regarding acceptance criteria and study details for this non-AI diagnostic device.
Here's the breakdown based on the provided document:
Device Name: Access EPO
Intended Use: The Access EPO assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of erythropoietin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This assay is intended as an aid in the diagnosis of anemias and polycythemias.
1. Table of Acceptance Criteria and Reported Device Performance
The document defines performance characteristics (acceptance criteria implicitly by demonstrating acceptable results) through various analytical studies.
| Study Parameter | Acceptance Criteria (Implicit from demonstrated performance) | Reported Device Performance |
|---|---|---|
| Method Comparison | Slope close to 1, Intercept close to 0, High Correlation Coefficient (comparing new system to predicate) | N = 152 samples (141 native, 11 spiked) |
- Concentration Range: 0.79 - 697 mIU/mL (Access 2 values)
- Slope: 0.99 (95% CI: 0.97 – 1.00)
- Intercept: -0.040 (95% CI: -0.19 – 0.22)
- Correlation Coefficient (R): 1.00
(Demonstrates substantial equivalence to predicate) |
| Imprecision (Within-Laboratory) | ≤ 0.30 mIU/mL SD at concentrations ≤ 3.0 mIU/mL
≤ 10.0% CV at concentrations > 3.0 mIU/mL | Performed on four Dxl 9000 Access Immunoassay Analyzers, testing four native samples and one spiked sample. All reported within-laboratory %CVs are well below 10% for concentrations > 3.0 mIU/mL, and SDs are below 0.30 mIU/mL for concentrations ≤ 3.0 mIU/mL. - Sample 1 (2.0 mIU/L): Within-Laboratory SD 0.07, %CV 3.8
- Sample 2 (18 mIU/L): Within-Laboratory SD 0.5, %CV 3.0
- Sample 3 (105 mIU/L): Within-Laboratory SD 2.8, %CV 2.7
- Sample 4 (267 mIU/L): Within-Laboratory SD 6.3, %CV 2.4
- Sample 5 (548 mIU/L): Within-Laboratory SD 20.4, %CV 3.7 |
| Linearity | Assay demonstrates linearity across the measuring interval. | "The assay demonstrated linearity across the measuring interval" (Specific range is 0.6-750 mIU/L, as stated in the "Measuring Range" table). |
| Limit of Blank (LoB) | Not explicitly stated as acceptance criteria, but claimed value is provided. | Claimed LoB for Access assay is 0.6 mIU/mL. |
| Limit of Detection (LoD) | Not explicitly stated as acceptance criteria, but claimed value is provided. | Claimed LoD for Access assay is 0.6 mIU/mL. |
| Limit of Quantitation (LoQ) | Not explicitly stated as acceptance criteria, but claimed value is provided. | Claimed LoQ for Access assay is 0.6 mIU/mL. |
2. Sample Size Used for the Test Set and Data Provenance
- Method Comparison Test Set: 152 samples (141 native, 11 spiked).
- Imprecision Test Set: 5 samples (4 native, 1 spiked), tested in duplicate in 2 runs per day for 20 days on each of four analyzers (total 80 replicates per sample).
- Data Provenance: The document does not specify the country of origin for the samples or if they were retrospective or prospective. Given it's a 510(k) submission for a laboratory diagnostic, the samples are typically human biological samples collected for validation purposes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not an image-based AI diagnostic device requiring expert adjudication of images. The "ground truth" for an immunoassay is typically established through reference methods or analysis of sample characteristics (e.g., known concentrations for spiked samples, or comparison to a cleared predicate device for native samples).
4. Adjudication Method for the Test Set
Not applicable, as it's an immunoassay for quantitative determination of erythropoietin, not a subjective interpretation task that would require adjudication.
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
Not applicable. This device is an automated immunoassay system, not an AI-assisted diagnostic tool that involves human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable in the context of an "algorithm only" AI performance. The performance described here is the "standalone" performance of the immunoassay system (Dxl 9000 Access Immunoassay Analyzer with Access EPO assay reagents).
7. The Type of Ground Truth Used
The ground truth for this device's performance evaluation is established through:
- Comparison to a Predicate Device: For the method comparison study, the predicate device (Access EPO Assay on Access 2 Immunoassay System) served as the reference for native samples.
- Known Concentrations: For imprecision and linearity studies, samples of known or targeted concentrations (including spiked samples) are used.
- Reference Standards/Materials: Implied for establishing accurate concentrations for LoB, LoD, and LoQ.
8. The Sample Size for the Training Set
Not applicable. This is an immunoassay, not a machine learning model that requires a "training set" in the conventional sense of AI development. The "training" of the instrument involves calibration using specific calibrators provided with the assay.
9. How the Ground Truth for the Training Set Was Established
Not applicable as there is no "training set" for an AI model. The "calibration" of the immunoassay is done using Access EPO Calibrators, which are intended to calibrate the assay. The ground truth for these calibrators would be established by the manufacturer through rigorous analytical methods to assign their precise concentrations.
§ 864.7250 Erythropoietin assay.
(a)
Identification. A erythropoietin assay is a device that measures the concentration of erythropoietin (an enzyme that regulates the production of red blood cells) in serum or urine. This assay provides diagnostic information for the evaluation of erythrocytosis (increased total red cell mass) and anemia.(b)
Classification. Class II. The special control for this device is FDA's “Document for Special Controls for Erythropoietin Assay Premarket Notification (510(k)s).”