(365 days)
The RX Daytona is an automated clinical chemistry analyser complete with dedicated analyser software. Software functions of the analyser include the facility to interact with a host computer Sonthare fantalo fancilerian selection details for individual samples. A barcode system is used for the rapid identification of patient samples, reagents and QC samples.
The analyser can be used to run tests including glucose in serum samples. Various other rro analyson be accent be analyser. Glucose measurements may be used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia and pancreatic islet cell carcinoma.
An Ion Selective Electrode (ISE) unit is an optional addition, which may be used with the AI Daytona Analyser for the measurement of the electrolytes sodium, potassium and chloride in serum, or urine. The ISE unit consists of ion selectrodes, supply and drain pump, preamplifier board and I/O board.
Sodium measurements may be used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion or other diseases involving electrolyte imbalance. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases characterised by low or high levels of potassium. Chloride measurements are used in the diamosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The RX Daytona analyser and ISE unit must only be used by suitably qualified personnel, under appropriate laboratory conditions.
For in vitro diagnostic use only.
The RX Daytona is an automated clinical chemistry analyser complete with dedicated analyser software. Software functions of the analyser include the facility to interact with a host computer Sonthare fantalo fancilerian selection details for individual samples. A barcode system is used for the rapid identification of patient samples, reagents and QC samples.
An Ion Selective Electrode (ISE) unit is an optional addition, which may be used with the AI Daytona Analyser for the measurement of the electrolytes sodium, potassium and chloride in serum, or urine. The ISE unit consists of ion selectrodes, supply and drain pump, preamplifier board and I/O board.
I'm sorry, but this document does not contain the information requested. The document is an FDA 510(k) clearance letter for the RX DAYTONA clinical chemistry analyzer. It describes the device's indications for use and states that it has been found substantially equivalent to legally marketed predicate devices. However, it does not provide details about specific acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment for performance evaluation.
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. 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.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.