(338 days)
The Eon 100 is a discrete photometric chemistry analyzer for clinical use. It is a device intended for the in-vitro, spectrophotometric determination of general chemistry assays. The Eon 100 has replaceable parts, automated maintenance monitoring and backup of both patient and system data.
The Eon 100 Chemistry Analyzer is intended to be used to assist the clinician with the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease.
The Eon 100 includes an optional Ion Selective Electrodes (ISE) module for the measurement of sodium, potassium and chloride in serum and plasma.
The Eon 100 is for in vitro diagnostic use only.
The Eon 100 is a discrete photometric chemistry analyzer for clinical use. It is a device intended for the in-vitro, spectrophotometric determination of general chemistry assays. The Eon 100 has replaceable parts, automated maintenance monitoring and backup of both patient and system data. The Eon 100 includes an optional Ion Selective Electrodes (ISE) module for the measurement of sodium, potassium and chloride in serum and plasma.
I am sorry, but the provided text from the FDA 510(k) summary for the EON 100 Chemistry Analyzer does not contain detailed information regarding the specific acceptance criteria, study design, or the performance data in the format you requested for a software or AI device.
The document primarily focuses on the regulatory clearance for various reagents and the analyzer itself as "substantially equivalent" to legally marketed predicate devices. It lists the indications for use for each component, but it does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or details about training sets.
- Information about expert involvement for ground truth, adjudication methods, or MRMC studies.
- Details on standalone algorithm performance or the type of ground truth used.
This type of detailed performance data and study design is typically found in the full 510(k) submission, which is not fully provided here, or in associated scientific publications or clinical study reports. The FDA 510(k) summary is generally a high-level document confirming substantial equivalence based on information submitted by the manufacturer.
§ 862.1160 Bicarbonate/carbon dioxide test system.
(a)
Identification. A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.(b)
Classification. Class II.