510(k) Report

510(k) · Cleared

Cleared

Liaison 25 OH Vitamin D Total; Assay, Control Set and Specimen Diluent Set, Models 310600, 310601 and 310602

K071480510(k) TraditionalCleared Oct 1, 2007125-day reviewClass II21 CFR 862.1825

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

DiaSorin, Inc. · MRG System, Test, Vitamin D

Cleared on Oct 1, 2007 as substantially equivalent to K032844 (DiaSorin, Inc., 2004) after a 125-day review. Its family tree reaches back 1 generation to 2004. 24 later devices descend from it.

Decided
Oct 1, 2007
Review
125 days
Class
Class II
Product code
MRG
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K032844 (2004). 24 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2014: 3 descendants cleared2009: 1 descendant cleared2016: 2 descendants cleared2013: 4 descendants cleared2012: 2 descendants cleared2017: 4 descendants cleared2019: 1 descendant cleared2023: 2 descendants cleared2024: 1 descendant cleared2018: 1 descendant cleared2026: 1 descendant cleared2021: 1 descendant clearedK032844 · Liaison 25 OH Vitamin D · DiaSorin, Inc. · 2004 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 6 descendants2 generations forward: 8 descendants3 generations forward: 4 descendants4 generations forward: 5 descendants5 generations forward: 1 descendant K032844 · Liaison 25 OH Vitamin D · DiaSorin, Inc. · 2004 · recalled0+5
  1. Root · 1 generation backK032844 Liaison 25 OH Vitamin DDiaSorin, Inc. · 2004 · Recalled
  2. This deviceK071480 Liaison 25 OH Vitamin D Total; Assay, Control Set and Specimen…DiaSorin, Inc. · 2007
  3. Descendant · cites it directly · 11 of its ownK110619 Architect 25-OH Vitamin D 100T, Vitamin D 500T, Vitamin D…Biokit, S.A. · 2011 · Recalled
  4. Descendant · 2 generations on · 8 of its ownK113546 Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys…Roche Diagnostics · 2012
  5. Descendant · cites it directly · 8 of its ownK112725 Liaison 25 OH Vitamin D Total AssayDiaSorin, Inc. · 2012
  6. Descendant · 3 generations on · 4 of its ownK162840 Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl…Roche Diagnostics · 2017 · Recalled
  7. Descendant · 3 generations on · 2 of its ownK132828 Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys…Roche Diagnostics · 2013

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2009: 12011: 12012: 22013: 42014: 32016: 22017: 42018: 12019: 12021: 12023: 22024: 12026: 1
2009high 4 (2013) · low 0 (2010)2026

Most influential descendants

Showing 5 of 24 · See all
  • K110619Architect 25-OH Vitamin D 100T, Vitamin D 500T, Vitamin D Calibrators, Vitamin D ControlsBiokit, S.A. · 2011 · cites it directly11descendants
  • K113546Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys…Roche Diagnostics · 2012 · 2 generations on8descendants
  • K112725Liaison 25 OH Vitamin D Total AssayDiaSorin, Inc. · 2012 · cites it directly8descendants
  • K162840Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II…Roche Diagnostics · 2017 · 3 generations on4descendants
  • K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3Roche Diagnostics · 2013 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K032844Liaison 25 OH Vitamin DDiaSorin, Inc.20044
0 (this device)K071480Liaison 25 OH Vitamin D Total; Assay, Control Set and Specimen Diluent Set…DiaSorin, Inc.2007—
+1K110619Architect 25-OH Vitamin D 100T, Vitamin D 500T, Vitamin D Calibrators, Vitamin…Biokit, S.A.20111
+2K113546Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3…Roche Diagnostics2012—
+1K112725Liaison 25 OH Vitamin D Total AssayDiaSorin, Inc.2012—
+3K162840Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D…Roche Diagnostics20172
+3K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol…Roche Diagnostics2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201110
201220
201340
201430
201620
201740
201810
201910
202110
202320
202410
202610
FIG. 1 — Lineage of K071480, 2004–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K221817 ALFIS Vitamin D, ALFIS-3 Analyzerscore 8.8 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K032844Liaison 25 OH Vitamin D
Summary page 1
…m (21 CFR 862.1825) Product Code: MRG, JJX PREDICATE DEVICES: LIAISON® 25 OH Vitamin D Assay and Controls (K032844) INTENDED USE: The LIAISON® 25 OH Vitamin D TOTAL Assay uses chemiluminescent i…
DiaSorin, Inc.20044

Also cleared against K032844: 2 other devices →

What descends from it? (24)

See all 24

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K110619Architect 25-OH Vitamin D 100T, Vitamin D 500T, Vitamin D Calibrators, Vitamin D ControlsBiokit, S.A.201111
K112725Liaison 25 OH Vitamin D Total AssayDiaSorin, Inc.20128
K090104Liaison 25 OH Vitamin D Total Calibration Verifiers, Model: 310603DiaSorin, Inc.20092
K153361Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D CalibratorsFujirebio Diagnostics,Inc.20160
K133410Diazyme 25-OH Vitamin D Assay; Diazyme 25-OH Vitamin D Control SetDiazyme Laboratories20140
K130321Liaison Aldosterone, Liaison Aldosterone Control Set, Liaison Aldosterone Calibration…Diasorin20130

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?

  • Its one ancestor has a recall.
  • Of its descendants, K110619 (Biokit, S.A., 2011) has gone furthest, with 11 descendants of its own.
  • 2 other devices also cite its predicate K032844.

How does its category compare?

All MRG devices

MRG System, Test, Vitamin D: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · MRG

1in 2024

2007: 12008: 12010: 12011: 32012: 32013: 72014: 62015: 32016: 32017: 32018: 22019: 12020: 12021: 12023: 22024: 1
2007high 7 (2013) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MRG

120in 2017

2011: 227 days median2012: 122 days median2013: 231 days median2014: 159 days median2015: 264 days median2016: 147 days median2017: 120 days median
2007high 264 (2015) · low 120 (2017)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MRG

2in 2025

2007: 12008: 22012: 32013: 12016: 22018: 22025: 2
2007high 3 (2012) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MRG

29in 2025

2009: 12011: 12012: 232013: 212014: 142015: 182016: 142017: 212018: 752019: 382020: 102021: 152022: 132023: 222024: 322025: 29
2007high 75 (2018) · low 0 (2007)2025

MAUDE reports naming product code MRG, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—10
20081—20
20090—01
20101—00
2011322701
20123122323
20137231121
20146159014
20153264018
20163147214
20173120021
20182—275
20191—038
20201—010
20211—015
20220—013
20232—022
20241—032
20250—229
20260—0—

What is it indicated for?

The LIAISON® 25 OH Vitamin D TOTAL Assay uses chemiluminescent immunoassay (CLIA) technology for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated vitamin D metabolites in human serum, EDTA-plasma or lithium heparin plasma to be used in the assessment of vitamin D sufficiency. Assay results should be used in conjunction with other clinical or laboratory data to assist the clinician in making individual patient management…

Read the full statement (136 words)

The LIAISON® 25 OH Vitamin D TOTAL Assay uses chemiluminescent immunoassay (CLIA) technology for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated vitamin D metabolites in human serum, EDTA-plasma or lithium heparin plasma to be used in the assessment of vitamin D sufficiency. Assay results should be used in conjunction with other clinical or laboratory data to assist the clinician in making individual patient management decisions in an adult population.

The LIAISON® 25 OH Vitamin D TOTAL Control Set is intended for use as assayed quality control samples to monitor the accuracy and precision of the DiaSorin LIAISON® 25 OH Vitamin D TOTAL Assay.

The LIAISON® 25 OH Vitamin D TOTAL Specimen Diluent Set may be used to dilute specimens with values greater that 150 ng/mL by the LIAISON® 25 OH Vitamin D TOTAL Assay.

Indications for use as stated in the FDA summary.

Also cleared against K032844

2 other devices cite the same predicate.

  • K103529Liaison XL Analyzer Model 10050DiaSorin, Inc. · 2011
  • K072536Esa Biosciences Inc. Vitamin D HPLC TestEsa Biosciences, Inc. · 2008

More from DiaSorin, Inc.

444 FDA decisions under this applicant name. See the company

  • P180047/S046LIAISON® QuantiFERON®-TB Gold Plus II.DiaSorin, Inc. · 2026
  • P180047/S045LIAISON QuantiFERON-TB Gold III; LIAISON Control QuantiFERON-TB Gold III; LIAISON QuantiFERON-TB Gold Plus…DiaSorin, Inc. · 2026
  • P180047/S043LIAISON QuantiFERON-TB Gold Plus; LIAISON XL Control QuantiFERON-TB Gold Plus; LIAISON QuantiFERON-TB Gold…DiaSorin, Inc. · 2026
  • P220034/S010LIAISON Biotrin Parvovirus B19 IgG Plus; LIAISON Biotrin Control Parvovirus B19 IgG PlusDiaSorin, Inc. · 2026
  • P220034/S011LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG PlusDiaSorin, Inc. · 2026

Recent decisions in MRG

The MRG category page

  • K232587MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzerShenzhen New Industries Biomedical Engineering Co., Ltd. · 2024
  • K221817ALFIS Vitamin D, ALFIS-3 AnalyzerImmunostics Inc., · 2023
  • K223503Access 25(OH) Vitamin D TotalBeckman Coulter, Inc. · 2023
  • K210901Elecsys Vitamin D total IIIRoche Diagnostics · 2021
  • K200509ADVIA Centaur Vitamin D Total (VitD)Siemens Healthcare Diagnostics, Inc. · 2020

https://510kreport.com/device/K071480 · printed Nov 6, 2026

Cite this page

510(k) Report. “K071480: Liaison 25 OH Vitamin D Total; Assay, Control Set and Specimen Diluent Set, Models 310600, 310601 and 310602.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071480

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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