510(k) · Cleared
Recalled · Class III · 201825OH Vitamin D Total Elisa Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diasource Immunoassays, S.A. · MRG System, Test, Vitamin D
Cleared on Jul 15, 2013 as substantially equivalent to K021163 (Immunodiagnostic Systems, Ltd., 2002) after a 256-day review. Its family tree reaches back 1 generation to 2002. It has been recalled once.
- Decided
- Jul 15, 2013
- Review
- 256 days
- Class
- Class II
- Product code
- MRG
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K021163 (2002). No later device cites it as a predicate yet.
- Root · 1 generation backK021163 Octeia 25-Hydroxy Vitamin DImmunodiagnostic Systems, Ltd. · 2002 · Recalled
- This deviceK123364 25OH Vitamin D Total Elisa TestDiasource Immunoassays, S.A. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021163 | Octeia 25-Hydroxy Vitamin D | Immunodiagnostic Systems, Ltd. | 2002 | 2 |
| 0 (this device) | K123364 | 25OH Vitamin D Total Elisa Test | Diasource Immunoassays, S.A. | 2013 | — |
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 MRG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MRG device
- #1 K221817 ALFIS Vitamin D, ALFIS-3 Analyzerscore 8.8 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K021163 | Octeia 25-Hydroxy Vitamin DSummary page 1…muno diagnrostic systems 25-Hydroxy Vitamin IDEIA for the quantitative determination of 25- hydroxy vitamin D and other liydroxylated metabolites in serum or plasmna. K021 163. 4) Description of the device: The assay requires a total of 165 minutes incubation time. The DIAsource 25 OH Vitamin D Total… | 2002 |
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 11, 2018 | Class III | Z-0410-2019 | Unknown/Undetermined by firm | The kit was provided without a copy of the lot-specific kit booklet and the Calibrator 0 vial 18D1/4 label incorrectly specified reconstitution volume of 2mL. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 5 other devices also cite its predicate K021163.
How does its category compare?
All MRG devicesMRG System, Test, Vitamin D: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · MRG
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MRG
120in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MRG
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRG
29in 2025
MAUDE reports naming product code MRG, 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 | — | 1 | 0 |
| 2008 | 1 | — | 2 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 3 | 227 | 0 | 1 |
| 2012 | 3 | 122 | 3 | 23 |
| 2013 | 7 | 231 | 1 | 21 |
| 2014 | 6 | 159 | 0 | 14 |
| 2015 | 3 | 264 | 0 | 18 |
| 2016 | 3 | 147 | 2 | 14 |
| 2017 | 3 | 120 | 0 | 21 |
| 2018 | 2 | — | 2 | 75 |
| 2019 | 1 | — | 0 | 38 |
| 2020 | 1 | — | 0 | 10 |
| 2021 | 1 | — | 0 | 15 |
| 2022 | 0 | — | 0 | 13 |
| 2023 | 2 | — | 0 | 22 |
| 2024 | 1 | — | 0 | 32 |
| 2025 | 0 | — | 2 | 29 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The DIAsource 25OH Vitamin D Total ELISA Test is intended for the quantitative
determination of 25-hydroxyvitamin D2 and D3 (25-OH D2 and 25-OH D3) in
human serum. The results are to be used in conjunction with other clinical and
laboratory findings to assess the Vitamin D status of a patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123364 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123364: 25OH Vitamin D Total Elisa Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123364
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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