(364 days)
Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of myoglobin levels in human serum and plasma using the Access Immunoassay Systems. Measurement of myoglobin aids in the rapid diagnosis of heart and renal diseases.
The Access Myoglobin reagent and calibrators, the Access Immunoassay Analyzers comprise the Access Immunoassay Systems for the quantitative determination of cardiac Myoglobin in human serum and plasma.
The provided 510(k) summary focuses on a single performance characteristic: imprecision. The submission is for a modified version of an already cleared device, and the only change noted is to the acceptable imprecision range in the Instructions For Use (IFU).
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from modified IFU) | Reported Device Performance (Myoglobin) |
|---|---|---|
| Total Imprecision (%CV) | ≤ 10% across the expected physiological range | 7.32% CV to 9.25% CV |
The reported device performance (7.32% CV to 9.25% CV) falls within the updated acceptance criteria (≤ 10% CV).
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The summary mentions "concentrations from approximately 79 to 2405 ng/mL" for imprecision testing, but not the number of individual samples or replicates used.
- Data Provenance: Not explicitly stated. There is no information regarding the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of submission. The device is an immunoassay for quantitative determination of myoglobin, and the "ground truth" for evaluating imprecision is determined by statistical analysis of repeat measurements, not by expert interpretation of samples.
4. Adjudication Method for the Test Set
This information is not applicable as it relates to expert consensus for ground truth, which is not relevant for imprecision studies of an immunoassay.
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 information is not applicable. This submission is for an immunoassay for myoglobin, not an AI-assisted diagnostic imaging device that involves human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a laboratory immunoassay device, not an algorithm, and does not involve human-in-the-loop performance in the same way as an AI-driven image analysis tool. The performance described (imprecision) is inherently "standalone" in the sense that it measures the inherent variability of the assay itself.
7. The Type of Ground Truth Used
The ground truth for imprecision studies is the measured value itself and its statistical distribution. Repeated measurements of the same sample are used to assess the variability (imprecision) of the assay. There isn't an external "truth" in the way there would be for disease diagnosis (e.g., pathology).
8. The Sample Size for the Training Set
This information is not applicable. This device is a biochemical assay and does not involve machine learning models that require a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no training set for this type of device.
§ 866.5680 Myoglobin immunological test system.
(a)
Identification. A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.(b)
Classification. Class II (performance standards).