(123 days)
The Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. Applications include colorimetric, turbidimetric, latex agglutination, homogeneous enzyme immunoassay, and ion selective electrode.
The Glucose test system is for the quantitative measurement of glucose in human serum, plasma, urine and cerebrospinal fluid on Beckman Coulter AU analyzers. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
The Potassium test system is for the quantitative measurement of potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
The Magnesium test system is for the quantitative measurement of Magnesium in human serum, plasma and urine on Beckman Coulter AU analyzers. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).
The AU5800 clinical chemistry analyzer is a fully automated, random access analyzer, designed for ultra-high throughput laboratories. This system is designed to suit varying workloads and is available in different configurations, from a one-single photometric module AU5810, up to a four-photometric module AU5840. The AU5800 analyzer measures analytes in samples using the same reagents, calibrators, quality control (QC) materials and other consumables used within the AU series of instruments. This ensures the same reliable results and references ranges across the AU family members. This system carries out automated analysis of serum, plasma, urine samples and other body fluids and automatically generates results. Electrolyte measurement is performed using a single or double cell lon Selective Electrode (ISE) which is also common among the other members of the AU family.
The provided 510(k) summary for the AU5800 Clinical Chemistry Analyzer describes a predicate device comparison and does not include acceptance criteria or a study design in the traditional sense of a standalone algorithm or a comparative effectiveness study involving human readers. Instead, it focuses on demonstrating substantial equivalence to a previously cleared device (AU2700 Clinical Chemistry Analyzer) through performance validations and comparisons of representative assays.
Here's an breakdown based on the information provided, recognizing that many requested fields are not applicable to this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state numerical acceptance criteria for the AU5800 against each specific performance metric (like accuracy, sensitivity, specificity, etc.) as would be seen for a novel device. Instead, the acceptance criterion is "demonstrate equivalence between the proposed AU5800 and the predicate device (AU2700)" across various performance parameters.
The reported performance is qualitative, stating that "The submission provides the data necessary to demonstrate this equivalence based on the performance validations and comparisons conducted between the representative reagents and analyzer platforms. Based on this data, the new AU5800 Chemistry Analyzer is substantially equivalent to the referenced predicate(s)."
The performance testing indicated for demonstrating equivalence includes:
| Performance Metric | Reported Device Performance (AU5800 vs. AU2700) |
|---|---|
| Linearity | Equivalence demonstrated |
| Precision | Equivalence demonstrated |
| Method Comparison | Equivalence demonstrated |
| Sensitivity | Equivalence demonstrated |
| Interference | Equivalence demonstrated |
| Reference Range | Equivalence demonstrated |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Representative assays from the AU chemistry menu were selected to demonstrate equivalency between the proposed AU5800 and the predicate device." However, specific sample sizes for the test sets (patient samples, controls, standards) used for each performance validation (linearity, precision, etc.) are not provided in this summary.
The data provenance is implicit: it's laboratory data generated internally by Beckman Coulter during the development and validation of the AU5800. The data is prospective in the sense that it was generated for the purpose of demonstrating equivalence for this submission. The country of origin is not specified, but given Beckman Coulter's location in Brea, CA, USA, it's likely primarily US-based, though this is not explicitly stated.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not Applicable. This is an in vitro diagnostic (IVD) device for clinical chemistry analysis. Ground truth for chemical measurements is typically established through reference methods, certified reference materials (NIST SRMs are mentioned for traceability), and established analytical practices, not by expert human graders or reviewers in the way that, for example, an imaging AI would be.
4. Adjudication Method for the Test Set
Not Applicable. See point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret results, sometimes with AI assistance. The AU5800 is a clinical chemistry analyzer that produces quantitative measurements, not interpretations requiring human reader input in the same way.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
Yes, in essence, the entire submission describes standalone performance testing. The AU5800 is an automated analyzer. The "performance validation and comparisons conducted between the representative reagents and analyzer platforms" demonstrate the performance of the device itself (the "algorithm" being the instrument's analytical processes) in producing measurements. There is no human-in-the-loop component for the analytical process of the device itself; it is fully automated.
7. Type of Ground Truth Used
The ground truth for the performance validations, particularly for method comparison, linearity, and precision, would be established by:
- Predicate Device Results: For method comparison, the results obtained from the predicate AU2700 would serve as a comparative "ground truth" or reference to assess the agreement of the AU5800.
- Certified Reference Materials/Standards: For linearity and calibration, measurements against materials with known, accurately determined concentrations (e.g., NIST SRMs like 916a, 965a, 909a-2, 909b mentioned for traceability) are used.
- Established Analytical Methods: For accuracy and other parameters, results might be compared to recognized reference methods in clinical chemistry.
8. Sample Size for the Training Set
Not Applicable. The AU5800 is a clinical chemistry analyzer, not a machine learning or AI algorithm that requires a "training set" in the conventional sense of developing a predictive model. Its "training" is in its engineering design, calibration, and validation against known standards and the predicate device.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. See point 8.
§ 862.1600 Potassium test system.
(a)
Identification. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.(b)
Classification. Class II.