# K052914: RX Imola

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Mar 31, 2006 after 168 days
- Product code: CEM (Electrode, Ion Specific, Potassium)
- Device class: 2
- Regulation: 21 CFR 862.1600
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K230890: ISE Electrodes (2023), 0 descendants of its own
- K131554: RX Daytona Plus Chemistry Analyzer; RX Daytona Plus Aspartate Aminotransferase (Ast) Reagent (2014), 0 descendants of its own

## Recalls of this device
- Sep 6, 2023 · Class II · Z-0200-2024: 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 
- Jun 24, 2019 · Class II · Z-2084-2019: 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.
- May 4, 2018 · Class II · Z-2059-2018: Abnormal premature termination of the software could affect the use of the analyser when running patient samples. The impact being a delay in reporting test results.
- Apr 14, 2016 · Class II · Z-0725-2017: According to the firm, Carry over was observed when the amylase or pancreatic amylase test is run directly before or after the Magnesium assay. An update is required to the RX Imola analyser running o

## Indications for use
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.

Source page: https://510kreport.com/device/K052914
Methodology: https://510kreport.com/methodology