# K024014: Randox RX Daytona

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Dec 4, 2003 after 365 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K112408: Poly-Chem 90 Ise Module (2011), 0 descendants of its own

## Recalls of this device
- Sep 6, 2023 · Class II · Z-0198-2024: RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with 

## Indications for use
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 for direct download of test method 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 assays are adaptable to the 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 RX Daytona Analyser for the measurement of the electrolytes sodium, potassium and chloride in serum, or urine. The ISE unit consists of ion selective electrodes, 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 diagnosis 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.

Source page: https://510kreport.com/device/K024014
Methodology: https://510kreport.com/methodology