510(k) · Cleared
Recalled · Class II · 2020Randox RX Daytona Plus Magnesium (MG)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Randox Laboratories, Ltd. · JGJ Photometric Method, Magnesium
Cleared on Apr 28, 2017 as substantially equivalent to K991576 (Bayer Corp., 1999) after a 266-day review. Its family tree reaches back 1 generation to 1999. It has been recalled once.
- Decided
- Apr 28, 2017
- Review
- 266 days
- Class
- Class I
- Product code
- JGJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991576 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK991576 Additional Assays for the Bayer Advia 1650 Chemistry SystemBayer Corp. · 1999 · Recalled
- This deviceK162200 Randox RX Daytona Plus Magnesium (MG)Randox Laboratories, Ltd. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991576 | Additional Assays for the Bayer Advia 1650 Chemistry System | Bayer Corp. | 1999 | 3 |
| 0 (this device) | K162200 | Randox RX Daytona Plus Magnesium (MG) | Randox Laboratories, Ltd. | 2017 | — |
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 JGJ? 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? (1)
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 |
|---|---|---|---|
| * | K991576 | Additional Assays for the Bayer Advia 1650 Chemistry SystemSummary page 5…004_510(K) SUMMARY 4. PREDICATE DEVICE PROPRIETARY NAMES AND 510 (k) NUMBERS Predicate Device Proprietary Name: Siemens Magnesium (MG) 510 (k) Number: k991576 5. INTENDED USE The Randox RX daytona plus magnesium (Mg) test system is intended for the quantitative in vitro determination o… | 1999 |
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 |
|---|---|---|---|---|
| Nov 13, 2020 | Class II | Z-0547-2021 | Under Investigation by firm | Failing to meet the linearity performance claims quoted on the kit inserts-The linearity is reduced by approximately -30% for Serum/ Plasma and -50% for Urine |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 11 other devices also cite its predicate K991576.
How does its category compare?
All JGJ devicesJGJ Photometric Method, Magnesium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · JGJ
2in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · JGJ
Too few JGJ 510(k)s in any year since 2007 to give a median.
Recalls per year · JGJ
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JGJ
22in 2025
MAUDE reports naming product code JGJ, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 1 | — | 0 | 13 |
| 2012 | 1 | — | 1 | 22 |
| 2013 | 0 | — | 1 | 26 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 1 | 24 |
| 2016 | 0 | — | 1 | 4 |
| 2017 | 2 | — | 0 | 18 |
| 2018 | 2 | — | 0 | 21 |
| 2019 | 0 | — | 1 | 31 |
| 2020 | 0 | — | 2 | 34 |
| 2021 | 0 | — | 1 | 33 |
| 2022 | 0 | — | 1 | 42 |
| 2023 | 0 | — | 0 | 31 |
| 2024 | 0 | — | 1 | 17 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Randox RX daytona plus magnesium (Mg) test system is intended for use in the quantitative determination of magnesium concentration in lithium heparinized plasma, serum and urine. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162200 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162200: Randox RX Daytona Plus Magnesium (MG).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162200
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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