(168 days)
The RX Imola is a medium-sized desktop fully Automated Clinical Chemistry Analyzer complete with Ion Selective Electrode (ISE) Unit and dedicated analyzer software. An external PC operates the analyzer and results can be printed as required. The analyzer may be connected to a host computer, when required.
The analyzer can be used to run tests such as magnesium in serum and plasma samples. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia and hypermagnesemia. Various other clinical chemistry assays are adaptable to the analyzer.
The ISE Unit on the RX Imola can be used for measurement of the electrolytes sodium, potassium and chloride in serum, plasma and urine and for use in diagnosis and treatment of electrolyte imbalance.
The RX Imola analyzer must only be used by suitably qualified personnel, under appropriate laboratory conditions.
For in vitro diagnostic use only.
The RX Imola is a medium-sized desktop fully Automated Clinical Chemistry Analyzer complete with Ion Selective Electrode (ISE) Unit and dedicated analyzer software. An external PC operates the analyzer and results can be printed as required. The analyzer may be connected to a host computer, when required.
I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets those criteria.
The document is a 510(k) clearance letter from the FDA for a device named "RX Imola, (Clinical Chemistry Analyser), ISE Unit & Magnesium Test Kit." It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the general controls and regulations it must comply with. The "Indications for Use" section describes what the device does (e.g., runs tests for magnesium, sodium, potassium, chloride in serum, plasma, and urine) and who should use it, but it does not provide:
- A table of acceptance criteria or reported device performance.
- Sample sizes for test sets or data provenance.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
- Information on standalone performance studies.
- The type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This type of detailed study information is typically found in the 510(k) submission itself or in scientific publications, not usually in the FDA clearance letter which primarily states the regulatory decision.
§ 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.