510(k) Report

510(k) · Cleared

Cleared

Liaison 25 OH Vitamin D Total Assay

K112725510(k) TraditionalCleared Jan 20, 2012122-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 Jan 20, 2012 as substantially equivalent to K071480 (DiaSorin, Inc., 2007) after a 122-day review. Its family tree reaches back 2 generations to 2004. 8 later devices descend from it.

Decided
Jan 20, 2012
Review
122 days
Class
Class II
Product code
MRG
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K032844 (2004). 8 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2013: 2 descendants cleared2014: 3 descendants cleared2019: 1 descendant cleared2023: 1 descendant cleared2024: 1 descendant clearedK032844 · Liaison 25 OH Vitamin D · DiaSorin, Inc. · 2004 · recalledK071480 · Liaison 25 OH Vitamin D Total; Assay, Control Set and Specimen Diluent Set, Models 310600, 310601 and 310602 · DiaSorin, Inc. · 2007200020052010201520202025
Descendants, by generation 1 generation forward: 6 descendants2 generations forward: 2 descendants K071480 · Liaison 25 OH Vitamin D Total; Assay, Control Set and Specimen Diluent Set, Models 310600, 310601 and 310602 · DiaSorin, Inc. · 2007K032844 · Liaison 25 OH Vitamin D · DiaSorin, Inc. · 2004 · recalled0
  1. Root · 2 generations backK032844 Liaison 25 OH Vitamin DDiaSorin, Inc. · 2004 · Recalled
  2. 1 generation backK071480 Liaison 25 OH Vitamin D Total; Assay, Control Set and Specimen…DiaSorin, Inc. · 2007
  3. This deviceK112725 Liaison 25 OH Vitamin D Total AssayDiaSorin, Inc. · 2012
  4. Descendant · cites it directly · 1 of its ownK191499 MAGLUMI 2000 25-OH Vitamin DShenzhen New Industries Biomedical Engineering Co., Ltd. · 2019
  5. Descendant · cites it directly · 1 of its ownK142373 Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst.…Beckman Coulter, Inc. · 2014
  6. Descendant · 2 generations on · 0 of its ownK232587 MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence…Shenzhen New Industries Biomedical Engineering Co., Ltd. · 2024
  7. Descendant · 2 generations on · 0 of its ownK223503 Access 25(OH) Vitamin D TotalBeckman Coulter, Inc. · 2023
  8. Descendant · cites it directly · 0 of its ownK142362 Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno.…Beckman Coulter, Inc. · 2014

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2013: 22014: 32019: 12023: 12024: 1
2013high 3 (2014) · low 0 (2015)2026

Most influential descendants

Showing 5 of 8 · See all
  • K191499MAGLUMI 2000 25-OH Vitamin DShenzhen New Industries Biomedical Engineering Co., Ltd. · 2019 · cites it directly1descendant
  • K142373Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH)…Beckman Coulter, Inc. · 2014 · cites it directly1descendant
  • K232587MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzerShenzhen New Industries Biomedical Engineering Co., Ltd. · 2024 · 2 generations on0descendants
  • K223503Access 25(OH) Vitamin D TotalBeckman Coulter, Inc. · 2023 · 2 generations on0descendants
  • K142362Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH)…Beckman Coulter, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K032844Liaison 25 OH Vitamin DDiaSorin, Inc.20044
−1K071480Liaison 25 OH Vitamin D Total; Assay, Control Set and Specimen Diluent Set…DiaSorin, Inc.2007—
0 (this device)K112725Liaison 25 OH Vitamin D Total AssayDiaSorin, Inc.2012—
+1K191499MAGLUMI 2000 25-OH Vitamin DShenzhen New Industries Biomedical Engineering Co., Ltd.2019—
+1K142373Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access…Beckman Coulter, Inc.2014—
+2K232587MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay…Shenzhen New Industries Biomedical Engineering Co., Ltd.2024—
+2K223503Access 25(OH) Vitamin D TotalBeckman Coulter, Inc.2023—
+1K142362Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access…Beckman Coulter, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201320
201430
201910
202310
202410
FIG. 1 — Lineage of K112725, 2004–2024Source: 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 8.7 · 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
*K071480Liaison 25 OH Vitamin D Total; Assay, Control Set and Specimen Diluent Set, Models…
Summary page 1
…e: MRG PREDICATE DEVICE: LIAISON® 25 OH Vitamin DTOTAL Assay (K071480) DEVICE DESCRIPTION: INTENDED USE: The LIAISON® 25 OH Vitamin D TOTAL Assay uses chemiluminescent immunoassay (CLIA) technology f…
DiaSorin, Inc.2007—

Also cleared against K071480: 5 other devices →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K191499MAGLUMI 2000 25-OH Vitamin DShenzhen New Industries Biomedical Engineering Co., Ltd.20191
K142373Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH)…Beckman Coulter, Inc.20141
K142362Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH)…Beckman Coulter, Inc.20140
K133410Diazyme 25-OH Vitamin D Assay; Diazyme 25-OH Vitamin D Control SetDiazyme Laboratories20140
K132492Liaison 25 Total-DDiaSorin, Inc.20130
K123983Fastpack Vitamin D; Immunoassay, Calibrators, Controls, VerifiersQualigen, Inc.20130

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 8 years and passes through 1 company; a new generation was cleared every 4.3 years on median.
  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K191499 (Shenzhen New Industries Biomedical Engineering Co., Ltd., 2019) has gone furthest, with 1 descendant of its own.
  • 5 other devices also cite its predicate K071480.

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. 2012, 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 hydraxylated vitamin 0 metabolites in human serum to be used in the assessment of vitamin 0 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.

Indications for use as stated in the FDA summary.

Also cleared against K071480

5 other devices cite the same predicate.

  • K153361Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D CalibratorsFujirebio Diagnostics,Inc. · 2016
  • K133410Diazyme 25-OH Vitamin D Assay; Diazyme 25-OH Vitamin D Control SetDiazyme Laboratories · 2014
  • K130321Liaison Aldosterone, Liaison Aldosterone Control Set, Liaison Aldosterone Calibration VerifiersDiasorin · 2013
  • K110619Architect 25-OH Vitamin D 100T, Vitamin D 500T, Vitamin D Calibrators, Vitamin D ControlsBiokit, S.A. · 20111 recall
  • K090104Liaison 25 OH Vitamin D Total Calibration Verifiers, Model: 310603DiaSorin, Inc. · 2009

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/K112725 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112725: Liaison 25 OH Vitamin D Total Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112725

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