510(k) · Cleared
ClearedLiaison 25 OH Vitamin D Total Calibration Verifiers, Model: 310603
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DiaSorin, Inc. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Sep 9, 2009 as substantially equivalent to K071480 (DiaSorin, Inc., 2007) after a 237-day review. Its family tree reaches back 2 generations to 2004. 2 later devices descend from it.
- Decided
- Sep 9, 2009
- Review
- 237 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K032844 (2004). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK032844 Liaison 25 OH Vitamin DDiaSorin, Inc. · 2004 · Recalled
- 1 generation backK071480 Liaison 25 OH Vitamin D Total; Assay, Control Set and Specimen…DiaSorin, Inc. · 2007
- This deviceK090104 Liaison 25 OH Vitamin D Total Calibration Verifiers, Model: 310603DiaSorin, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK132492 Liaison 25 Total-DDiaSorin, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK130321 Liaison Aldosterone, Liaison Aldosterone Control Set, Liaison…Diasorin · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K032844 | Liaison 25 OH Vitamin D | DiaSorin, Inc. | 2004 | 4 |
| −1 | K071480 | Liaison 25 OH Vitamin D Total; Assay, Control Set and Specimen Diluent Set… | DiaSorin, Inc. | 2007 | — |
| 0 (this device) | K090104 | Liaison 25 OH Vitamin D Total Calibration Verifiers, Model: 310603 | DiaSorin, Inc. | 2009 | — |
| +1 | K132492 | Liaison 25 Total-D | DiaSorin, Inc. | 2013 | — |
| +1 | K130321 | Liaison Aldosterone, Liaison Aldosterone Control Set, Liaison Aldosterone… | Diasorin | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 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 JJX? 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 |
|---|---|---|---|
| * | K071480 | Liaison 25 OH Vitamin D Total; Assay, Control Set and Specimen Diluent Set, Models…Summary page 1…PREDICATE DEVICES: LIAISON® 25 OH Vitamin D TOTAL Control Set Reference K071480 DEVICE DESCRIPTION: INTENDED USE: The DiaSorin LIAISON® 25 OH Vitamin D TOTAL Calibration Verifiers are… | 2007 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 5 years and passes through 1 company; a new generation was cleared every 3.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K132492 (DiaSorin, Inc., 2013) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K071480.
How does its category compare?
All JJX devicesJJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · JJX
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJX
31in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJX
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJX
22in 2025
MAUDE reports naming product code JJX, 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 | 6 | 53 | 3 | 2 |
| 2008 | 8 | 52 | 3 | 0 |
| 2009 | 17 | 80 | 0 | 1 |
| 2010 | 24 | 80 | 3 | 6 |
| 2011 | 19 | 62 | 2 | 62 |
| 2012 | 15 | 40 | 0 | 32 |
| 2013 | 19 | 37 | 0 | 51 |
| 2014 | 22 | 30 | 1 | 48 |
| 2015 | 11 | 65 | 1 | 67 |
| 2016 | 6 | 31 | 2 | 37 |
| 2017 | 2 | — | 0 | 19 |
| 2018 | 0 | — | 2 | 35 |
| 2019 | 0 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 77 |
| 2021 | 0 | — | 1 | 43 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The DiaSorin LIAISON® 25 OH Vitamin D TOTAL Calibration Verifiers are assayed quality control materials intended for in vitro diagnostic use in the quantitative verification of calibration and reportable range of the LIAISON® 25 OH Vitamin D TOTAL Assay when performed on the LIAISON® Analyzer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090104 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090104: Liaison 25 OH Vitamin D Total Calibration Verifiers, Model: 310603.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090104
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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