510(k) · Cleared
ClearedLiason XL1,25 Dihydroxyvitamin D; Control Set, Calibration Verifiers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DiaSorin, Inc. · MRG System, Test, Vitamin D
Cleared on Dec 10, 2014 as substantially equivalent to K014030 (DiaSorin, Inc., 2002) and 1 other predicate after a 190-day review. Its family tree reaches back 3 generations to 1995. 3 later devices descend from it.
- Decided
- Dec 10, 2014
- Review
- 190 days
- Class
- Class II
- Product code
- MRG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K954418 (1995). 6 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK954418 Intact Parathyroid Hormone (PTH) Immunoassay (Modification)Nichols Institute Diagnostics · 1995
- 2 generations backK020217 Acs:180 and Advia Centaur Ipth ImmunoassayBayer Diagnostics Corp. · 2002 · Recalled
- 1 generation backK132515 Liaison N-Tact PTH Gen II, Control Set, Calibration VerifiersDiaSorin, Inc. · 2013
- This deviceK141463 Liason XL1,25 Dihydroxyvitamin D; Control Set, Calibration VerifiersDiaSorin, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK182698 LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON…DiaSorin, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK213858 LIAISON Calprotectin, LIAISON Q.S.E.T. Device PlusDiaSorin, Inc. · 2022 · Recalled
- Descendant · cites it directly · 0 of its ownK173683 LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN…DiaSorin, Inc. · 2018
Most influential descendants
Showing 3 of 3 · See all- K182698LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration…DiaSorin, Inc. · 2018 · cites it directly1descendant
- K213858LIAISON Calprotectin, LIAISON Q.S.E.T. Device PlusDiaSorin, Inc. · 2022 · 2 generations on0descendants
- K173683LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN…DiaSorin, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954418 | Intact Parathyroid Hormone (PTH) Immunoassay (Modification) | Nichols Institute Diagnostics | 1995 | — |
| −2 | K020217 | Acs:180 and Advia Centaur Ipth Immunoassay | Bayer Diagnostics Corp. | 2002 | 4 |
| −1 | K132515 | Liaison N-Tact PTH Gen II, Control Set, Calibration Verifiers | DiaSorin, Inc. | 2013 | — |
| 0 (this device) | K141463 | Liason XL1,25 Dihydroxyvitamin D; Control Set, Calibration Verifiers | DiaSorin, Inc. | 2014 | — |
| +1 | K182698 | LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin… | DiaSorin, Inc. | 2018 | — |
| +2 | K213858 | LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus | DiaSorin, Inc. | 2022 | 1 |
| +1 | K173683 | LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS… | DiaSorin, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2022 | 1 | 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 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? (2)
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 |
|---|---|---|---|
| * | K014030 | 1,25-Dihydroxyvitamin D125I RiaSummary page 4…e device used to demonstrate substantial equivalence to the LIAISON® XL 1,25 Dihydroxyvitamin D is the DiaSorin 1,25 Dihydroxyvitamin D 125I RIA previously cleared under k014030. The predicate device used to demonstrate substantial equivalence to the LIAISON® XL 1,25 Dihydroxyvitamin D is t… | 2002 |
| * | K132515 | Liaison N-Tact PTH Gen II, Control Set, Calibration VerifiersSummary page 5…ate device used to demonstrate substantial equivalence to the LIAISON® XL 1,25 Dihydroxyvitamin D is the LIAISON® N-TACT® PTH Gen II Control Set previously cleared under k132515. The predicate device used to demonstrate substantial equivalence to the LIAISON® XL 1,25 Dihydroxyvitamin D Calibration Verifie… | 2013 |
What descends from it? (3)
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 19 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K182698 (DiaSorin, Inc., 2018) 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. 2014, 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 LIAISON® XL 1,25 Dihydroxyvitamin D is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of 1,25 dihydroxyvitamin (1,25(OH)2D) in serum, EDTA and Lithium Heparin plasma. Results of the 1,25 Dihydroxyvitamin D are used in the assessment of vitamin D sufficiency. Assay results should be used in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management…
Read the full statement (140 words)
The LIAISON® XL 1,25 Dihydroxyvitamin D is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of 1,25 dihydroxyvitamin (1,25(OH)2D) in serum, EDTA and Lithium Heparin plasma. Results of the 1,25 Dihydroxyvitamin D are used in the assessment of vitamin D sufficiency. Assay results should be used in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions in adult populations. The test is to be performed on the LIAISON® XL Analyzer.
The LIAISON® XL 1,25 Dihydroxyvitamin D Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® XL 1,25 Dihydroxyvitamin D assay.
The LIAISON® XL 1,25 Dihydroxyvitamin D Calibration Verifiers are assayed quality control materials intended for the quantitative verification of calibration and reportable range of the LIAISON® XL1,25 Dihydroxyvitamin D assay.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141463 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141463: Liason XL1,25 Dihydroxyvitamin D; Control Set, Calibration Verifiers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141463
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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