510(k) · Cleared
ClearedIDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immunodiagnostic Systems, Ltd. · MRG System, Test, Vitamin D
Cleared on Nov 15, 2016 as substantially equivalent to K140554 (Immunodiagnostic Systems, Ltd., 2014) after a 133-day review. Its family tree reaches back 2 generations to 2010.
- Decided
- Nov 15, 2016
- Review
- 133 days
- Class
- Class II
- Product code
- MRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K091849 (2010). No later device cites it as a predicate yet.
- Root · 2 generations backK091849 Ids-Isys 25-Hydroxy Vitamin D Assay, Ids-Isys 25-Hydroxy Vitamin D…Immunodiagnostic Systems, Inc. · 2010
- 1 generation backK140554 Ids-Isys 25-Hydroxy Vitamin DS, and Ids-Isys 25 Hydroxy Vitamin DS…Immunodiagnostic Systems, Ltd. · 2014
- This deviceK161831 IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control SetImmunodiagnostic Systems, Ltd. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K091849 | Ids-Isys 25-Hydroxy Vitamin D Assay, Ids-Isys 25-Hydroxy Vitamin D Control Set | Immunodiagnostic Systems, Inc. | 2010 | — |
| −1 | K140554 | Ids-Isys 25-Hydroxy Vitamin DS, and Ids-Isys 25 Hydroxy Vitamin DS Control Set | Immunodiagnostic Systems, Ltd. | 2014 | — |
| 0 (this device) | K161831 | IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set | Immunodiagnostic Systems, Ltd. | 2016 | — |
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 8.7 · 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 |
|---|---|---|---|
| * | K140554 | Ids-Isys 25-Hydroxy Vitamin DS, and Ids-Isys 25 Hydroxy Vitamin DS Control SetSummary page 5…mmercial distribution intended for similar use. We claim equivalency to the currently marketed IDS-iSYS 25- Hydroxy Vitamin DS (k140554). Device Description IDS-iSYS 25 VitDS The IDS-iSYS 25 VitDS reagent kit consists of one (1)… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 4.5 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All MRG devicesMRG System, Test, Vitamin D: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 IDS iSYS 25 VitD assay is intended for the quantitative determination of total 25-hydroxyvitamin D [(25(OH)D] in human serum or plasma on the IDS iSYS Multi-Discipline Automated System. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency in an adult population.
The IDS-iSYS 25 VitD Control Set is used for quality control of the IDS-iSYS 25 VitD assay on the IDS-iSYS Multi-Discipline Automated System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161831 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161831: IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161831
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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