510(k) · Cleared
Recalled · Class II · 2023RX Daytona Plus Chemistry Analyzer; RX Daytona Plus Aspartate Aminotransferase (Ast) Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Randox Laboratories, Ltd. · JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Cleared on Jan 9, 2014 as substantially equivalent to K052914 (Randox Laboratories, Ltd., 2006) and 1 other predicate after a 224-day review. Its family tree reaches back 1 generation to 1992. It has been recalled 3 times.
- Decided
- Jan 9, 2014
- Review
- 224 days
- Class
- Class I
- Product code
- JJE
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 1 generation to K923505 (1992). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK923505 Ast (Got) - Aspartate AminotransferaseRandox Laboratories, Ltd. · 1992
- This deviceK131554 RX Daytona Plus Chemistry Analyzer; RX Daytona Plus Aspartate…Randox Laboratories, Ltd. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923505 | Ast (Got) - Aspartate Aminotransferase | Randox Laboratories, Ltd. | 1992 | — |
| 0 (this device) | K131554 | RX Daytona Plus Chemistry Analyzer; RX Daytona Plus Aspartate Aminotransferase… | Randox Laboratories, Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JJE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052914 | RX ImolaSummary page 2…X Daytona Plus AST Reagent 4. PREDICATE DEVICE PROPRIETARY NAME AND 510 (k) NUMBER Randox RX Imola Chemistry Analyzer with ISE Sodium, Potassium and Chloride electrodes K052914. Randox AST assay K923505. 5. DEVICE DESCRIPTION RX Daytona Plus system The RX Daytona Plus is a bench-top fully automated ran… | 2006 |
| * | K923505 | Ast (Got) - Aspartate AminotransferaseSummary page 2…4. PREDICATE DEVICE PROPRIETARY NAME AND 510 (k) NUMBER Randox RX Imola Chemistry Analyzer with ISE Sodium, Potassium and Chloride electrodes K052914. Randox AST assay K923505. 5. DEVICE DESCRIPTION RX Daytona Plus system The RX Daytona Plus is a bench-top fully automated random access clinical anailys… | 1992 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 6, 2023 | Class II | Z-0199-2024 | Under Investigation by firm | 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 the re-run feature conditions when… |
| Dec 19, 2019 | Class II | Z-1349-2020 | Under Investigation by firm | 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 number) when searching the run/results… |
| Jun 24, 2019 | Class II | Z-2083-2019 | Under Investigation by firm | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K052914.
How does its category compare?
All JJE devicesJJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · JJE
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · JJE
224in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJE
6in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJE
4,400in 2025
MAUDE reports naming product code JJE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 20 | 2,181 |
| 2008 | 1 | — | 20 | 2,159 |
| 2009 | 0 | — | 14 | 3,440 |
| 2010 | 0 | — | 32 | 3,273 |
| 2011 | 2 | — | 25 | 11,606 |
| 2012 | 1 | — | 16 | 3,707 |
| 2013 | 1 | — | 21 | 2,489 |
| 2014 | 3 | 224 | 14 | 2,841 |
| 2015 | 0 | — | 15 | 2,793 |
| 2016 | 0 | — | 9 | 2,580 |
| 2017 | 0 | — | 18 | 1,869 |
| 2018 | 0 | — | 17 | 4,590 |
| 2019 | 1 | — | 7 | 3,948 |
| 2020 | 0 | — | 7 | 3,986 |
| 2021 | 0 | — | 6 | 3,920 |
| 2022 | 0 | — | 0 | 3,998 |
| 2023 | 0 | — | 12 | 3,783 |
| 2024 | 0 | — | 6 | 4,221 |
| 2025 | 0 | — | 6 | 4,400 |
| 2026 | 0 | — | 5 | — |
What is it indicated for?
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…
Read the full statement (162 words)
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:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131554 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131554: RX Daytona Plus Chemistry Analyzer; RX Daytona Plus Aspartate Aminotransferase (Ast) Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131554
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026