# K131554: RX Daytona Plus Chemistry Analyzer; RX Daytona Plus Aspartate Aminotransferase (Ast) Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Jan 9, 2014 after 224 days
- Product code: JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2160
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K923505 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052914: RX Imola, Randox Laboratories, Ltd. (2006) Summary page 2.
- K923505: Ast (Got) - Aspartate Aminotransferase, Randox Laboratories, Ltd. (1992) Summary page 2.

## Recalls of this device
- Sep 6, 2023 · Class II · Z-0199-2024: 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 
- Dec 19, 2019 · Class II · Z-1349-2020: Software version UI2550642107 for the RX Daytona + instrument released to correct the following issues: 1) The order of samples displayed is not sequential according to SID (sample identification numb
- Jun 24, 2019 · Class II · Z-2083-2019: There was a report of a malfunction with the sensor which resulted in an increase of temperature leading to melting of internal wires and scorch damage to the internal structure of the instrument.

## Indications for use
The RX Daytona Plus Chemistry analyzer is a bench top fully automated random access clinical chemistry analyzer intended for use in clinical laboratories. It is intended to be used for a variety of assay methods. The RX Daytona Plus includes an optional Ion Selective Electrode (ISE) module for the measurement of sodium, potassium and chloride in serum and urine. The RX Daytona Plus is not for Point-Of-Care testing. Sodium measurements are used in the diagnosis and treatment of diseases, involving electrolyte imbalance. Potassium measurements monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders. The RX Daytona Plus AST reagent is for the quantitative in vitro diagnostic determination of the activity of the enzyme Aspartate aminotransferase (AST) in human serum. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases:

Source page: https://510kreport.com/device/K131554
Methodology: https://510kreport.com/methodology