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510(k) Data Aggregation
(53 days)
ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZER
Per 21 CFR, 682.2160, the ALCYON Analyzer is a discrete photometric chemistry analyzer for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. The analyzer with the optional Ion-Selective Electrode (ISE) Module measures the concentration of the electrolytes, sodium, potassium, and chloride, in samples using indirect potentiometry.
The ALCYON Analyzer is an automated open system for quantitative analysis of clinical chemistries. The ALCYON Analyzer has an optional Ion-Selective Electrode (ISE) module which measures the concentration of the electrolytes, sodium, potassium, and chloride, in samples using indirect potentiometry.
This document describes the 510(k) submission for the Abbott ALCYON™ Analyzer, a clinical chemistry analyzer. The submission demonstrates substantial equivalence to previously cleared devices through performance characteristics, specifically correlation analysis, linearity, and precision.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the ALCYON Analyzer are established by demonstrating substantial equivalence to predicate devices. This is primarily shown through correlation analysis, where the ALCYON Analyzer's results for various assays are compared to those of the predicate devices. While explicit "acceptance criteria" are not numerically stated as thresholds, the high correlation coefficients and acceptable linearity and precision values demonstrate that the device performs comparably to established analyzers.
| Representative Method | Correlation Coefficient (Reported Device Performance) | Slope (Least-Squares) (Reported Device Performance) | Y-axis intercept (Reported Device Performance) | Linearity (Reported Device Performance) | Precision (Reported Device Performance) |
|---|---|---|---|---|---|
| Enzymatic Endpoint (Glucose) | 0.9891 | 0.865 | -1.698 mg/dL | To 700 mg/dL | 0.7 - 5.6 (normal controls) / 0.5 - 3.1 (abnormal controls) |
| Non-Enzymatic Endpoint (Total Protein) | 0.98 | 1.02 | -0.035 g/dL | To 12 g/dL | 0.7 - 5.6 (normal controls) / 0.5 - 3.1 (abnormal controls) |
| Rate Reaction (GGTP) | 0.9989 | 0.90 | -1.467 U/L | To 800 U/L | 0.7 - 5.6 (normal controls) / 0.5 - 3.1 (abnormal controls) |
| Sodium | 0.98 | 1.01 | -4.261 mEq/L | To 200 mEq/L | 0.7 - 5.6 (normal controls) / 0.5 - 3.1 (abnormal controls) |
| Potassium | 0.9981 | 1.014 | -01.101 mEq/L | To 15.0 mEq/L | 0.7 - 5.6 (normal controls) / 0.5 - 3.1 (abnormal controls) |
| Chloride | 0.990 | 0.904 | -10.493 mEq/L | To 140 mEq/L | 0.7 - 5.6 (normal controls) / 0.5 - 3.1 (abnormal controls) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for the correlation analysis, linearity studies, or precision studies. It mentions "representative methods" and "normal and abnormal controls" for precision, implying a set of samples were run for each.
The provenance of the data (country of origin, retrospective/prospective) is not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to the evaluation of a clinical chemistry analyzer in this context. The "ground truth" for the performance of such a device is typically established by comparing its analytical results to those of a predicate device, which itself is an established and validated analytical instrument. There is no mention of human experts interpreting results for the purpose of establishing ground truth for the device's performance.
4. Adjudication Method for the Test Set
Not applicable. The evaluation of a clinical chemistry analyzer generally involves direct analytical comparison to predicate devices, not human adjudication of results in the traditional sense of image or clinical interpretation.
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 is a clinical chemistry analyzer, not a diagnostic imaging or AI-assisted diagnostic device that involves human readers interpreting results.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies presented (correlation, linearity, precision) are all standalone performance evaluations of the ALCYON Analyzer. The device is designed for automated quantitative analysis, and its performance is assessed based on its ability to accurately and precisely measure analytes compared to established methods.
7. The Type of Ground Truth Used
The ground truth for the performance of the ALCYON Analyzer is the analytical results obtained from predicate devices. For example, in the correlation analysis, the results from the ALCYON Analyzer are compared to results obtained from "the Roche® Cobas® Mira Plus" and other predicate analyzers mentioned for electrolytes. The assumption is that these predicate devices provide an accepted and validated "ground truth" for analyte concentrations or activity.
8. The Sample Size for the Training Set
Not applicable. This device is a traditional automated clinical chemistry analyzer, not an AI/ML device that requires a distinct "training set" in the context of machine learning. The term "training set" is generally used when an algorithm learns from data; for this type of device, calibration materials are used to "train" the instrument to accurately measure analytes, but this is a different concept than an AI training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable in the AI/ML sense. For traditional clinical chemistry analyzers, "training" involves calibration using materials ("calibrators") with known concentrations. These known concentrations are the "ground truth" for establishing the instrument's calibration curve or response function. The text states:
- "For analytes, all three analyzers determine the concentration of unknown samples from a standard curve generated with known analyte concentrations."
- "All analyzers are calibrated with known concentration calibrator material."
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