510(k) · Cleared
ClearedIds-Isys 25-Hydroxy Vitamin D Assay, Ids-Isys 25-Hydroxy Vitamin D Control Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immunodiagnostic Systems, Inc. · MRG System, Test, Vitamin D
Cleared on Jun 25, 2010 after a 368-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Jun 25, 2010
- Review
- 368 days
- Class
- Class II
- Product code
- MRG
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK091849 Ids-Isys 25-Hydroxy Vitamin D Assay, Ids-Isys 25-Hydroxy Vitamin D…Immunodiagnostic Systems, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK140554 Ids-Isys 25-Hydroxy Vitamin DS, and Ids-Isys 25 Hydroxy Vitamin DS…Immunodiagnostic Systems, Ltd. · 2014
- Descendant · 2 generations on · 0 of its ownK161831 IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control SetImmunodiagnostic Systems, Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK142994 IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS…Immunodiagnostic Systems, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK121608 Vitros Immunodiagnostic Products 25-OH Vitamin D Total Reagent Pack…Ortho-Clinical Diagnostics, Inc. · 2013 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K140554Ids-Isys 25-Hydroxy Vitamin DS, and Ids-Isys 25 Hydroxy Vitamin DS Control SetImmunodiagnostic Systems, Ltd. · 2014 · cites it directly1descendant
- K161831IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control SetImmunodiagnostic Systems, Ltd. · 2016 · 2 generations on0descendants
- K142994IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone…Immunodiagnostic Systems, Ltd. · 2015 · cites it directly0descendants
- K121608Vitros Immunodiagnostic Products 25-OH Vitamin D Total Reagent Pack, Vitamin D Total…Ortho-Clinical Diagnostics, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K161831 | IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set | Immunodiagnostic Systems, Ltd. | 2016 | — |
| +1 | K142994 | IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS… | Immunodiagnostic Systems, Ltd. | 2015 | — |
| +1 | K121608 | Vitros Immunodiagnostic Products 25-OH Vitamin D Total Reagent Pack, Vitamin D… | Ortho-Clinical Diagnostics, Inc. | 2013 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140554 | Ids-Isys 25-Hydroxy Vitamin DS, and Ids-Isys 25 Hydroxy Vitamin DS Control Set | 2014 | 1 |
| K142994 | IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone… | 2015 | 0 |
| K121608 | Vitros Immunodiagnostic Products 25-OH Vitamin D Total Reagent Pack, Vitamin D Total… | 2013 | 0 |
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?
- Of its descendants, K140554 (Immunodiagnostic Systems, Ltd., 2014) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MRG devicesMRG System, Test, Vitamin D: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Multi-Discipline Automated Analyser is a discrete continuous loading chemiluminescent immunoassay analyzer for in vitro diagnostic use The IDS-iSYS 25-Hydroxy Vitamin D Assay is intended for the quantitative determination of 25-hydroxyvitamin 0 (25-OH D) and other hydroxylated metabolites in human serum on the IDS-iSYS Multi-Discipline Automated Analyser. Results are to be used in conjunction with other clinical and laboratory data to assist…
Read the full statement (114 words)
The IDS-iSYS Multi-Discipline Automated Analyser is a discrete continuous loading chemiluminescent immunoassay analyzer for in vitro diagnostic use
The IDS-iSYS 25-Hydroxy Vitamin D Assay is intended for the quantitative determination of 25-hydroxyvitamin 0 (25-OH D) and other hydroxylated metabolites in human serum on the IDS-iSYS Multi-Discipline Automated Analyser. 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 kit is for in vitro diagnostic use only. the IDS-iSYS 25-Hydroxy Vitamin D Control Set is intended for use as assayed quality control samples to monitor the accuracy and precision of the IDS-iSYS 25-Hydroxy Vitamin 0 Assay.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K091849 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091849: Ids-Isys 25-Hydroxy Vitamin D Assay, Ids-Isys 25-Hydroxy Vitamin D Control Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091849
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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