510(k) Report

510(k) · Cleared

Recalled · Class II · 2012

Architect 25-OH Vitamin D 100T, Vitamin D 500T, Vitamin D Calibrators, Vitamin D Controls

K110619510(k) TraditionalCleared Nov 23, 2011265-day reviewClass II21 CFR 862.1825Recalls 1

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

Biokit, S.A. · MRG System, Test, Vitamin D

Cleared on Nov 23, 2011 as substantially equivalent to K071480 (DiaSorin, Inc., 2007) after a 265-day review. Its family tree reaches back 2 generations to 2004. 11 later devices descend from it. It has been recalled once.

Decided
Nov 23, 2011
Review
265 days
Class
Class II
Product code
MRG
Recalls
1
Predicates
1

Its longest line of descent runs back 2 generations to K032844 (2004). 11 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2017: 4 descendants cleared2012: 1 descendant cleared2016: 1 descendant cleared2013: 1 descendant cleared2018: 1 descendant cleared2026: 1 descendant cleared2021: 1 descendant cleared2023: 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: 3 descendants2 generations forward: 2 descendants3 generations forward: 5 descendants4 generations forward: 1 descendant 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 deviceK110619 Architect 25-OH Vitamin D 100T, Vitamin D 500T, Vitamin D…Biokit, S.A. · 2011
  4. Descendant · cites it directly · 8 of its ownK113546 Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys…Roche Diagnostics · 2012
  5. Descendant · 2 generations on · 4 of its ownK162840 Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl…Roche Diagnostics · 2017 · Recalled
  6. Descendant · 2 generations on · 2 of its ownK132828 Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys…Roche Diagnostics · 2013
  7. Descendant · 3 generations on · 1 of its ownK210901 Elecsys Vitamin D total IIIRoche Diagnostics · 2021
  8. Descendant · 3 generations on · 0 of its ownK252431 Elecsys CalcitoninRoche Diagnostics GmbH · 2026

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2012: 12013: 12016: 12017: 42018: 12021: 12023: 12026: 1
2012high 4 (2017) · low 0 (2014)2026

Most influential descendants

Showing 5 of 11 · See all
  • K113546Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys…Roche Diagnostics · 2012 · cites it directly8descendants
  • K162840Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II…Roche Diagnostics · 2017 · 2 generations on4descendants
  • K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3Roche Diagnostics · 2013 · 2 generations on2descendants
  • K210901Elecsys Vitamin D total IIIRoche Diagnostics · 2021 · 3 generations on1descendant
  • K252431Elecsys CalcitoninRoche Diagnostics GmbH · 2026 · 3 generations on0descendants
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)K110619Architect 25-OH Vitamin D 100T, Vitamin D 500T, Vitamin D Calibrators, Vitamin…Biokit, S.A.2011—
+1K113546Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3…Roche Diagnostics2012—
+2K162840Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D…Roche Diagnostics20172
+2K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol…Roche Diagnostics2013—
+3K210901Elecsys Vitamin D total IIIRoche Diagnostics2021—
+3K252431Elecsys CalcitoninRoche Diagnostics GmbH2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201310
201610
201740
201810
202110
202310
202610
FIG. 1 — Lineage of K110619, 2004–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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
*K071480Liaison 25 OH Vitamin D Total; Assay, Control Set and Specimen Diluent Set, Models…
Summary page 1
…ce Classification: Class I Classification Panel: Chemistry Product Code: JJX Legally marketed device to which equivalency is claimed: LIAISON® 25 OH Vitamin D TOTAL (k<071480) Page 1 of 3 Intended Use of Device: The ARCHITE…
DiaSorin, Inc.2007—

Also cleared against K071480: 5 other devices →

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K113546Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys…Roche Diagnostics20128
K162754FREND Vitamin D Test SystemNanoentek USA, Inc.20170
K153375ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT…Abbott Laboratories20160

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Dec 12, 2012Class IIZ-0698-2013Mixed-up of materials/componentsThe Architect 25-OH Vitamin D assay has the potential to generate falsely elevated or falsely depressed results when used with certain lots of Architect Reaction Vessels.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K113546 (Roche Diagnostics, 2012) has gone furthest, with 8 descendants 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. 2011, 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?

Reagents The ARCHITECT 25-OH Vitamin 0 assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 25-hydroxyvitamin 0 (215-OH vitamin D) in human serum and plasma. The ARCHITECT 25-OH Vitamin D assay is.to be used as an aid in the assessment of vitamin D sufficiency. Calibrators The ARCHITECT 25-OH Vitamin 0 Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of…

Read the full statement (122 words)

Reagents

The ARCHITECT 25-OH Vitamin 0 assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 25-hydroxyvitamin 0 (215-OH vitamin D) in human serum and plasma. The ARCHITECT 25-OH Vitamin D assay is.to be used as an aid in the assessment of vitamin D sufficiency.

Calibrators

The ARCHITECT 25-OH Vitamin 0 Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of 25-hydroxyvitamin 0 (25-OH Vitamin 0) in human serum and plasma.

Controls

The ARCHITECT 25-OH Vitamin D Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System. when used for the quantitative determination of 25-hydroxyvitamin 0 (25-OH Vitamin 0) in human serum and plasma.

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
  • K112725Liaison 25 OH Vitamin D Total AssayDiaSorin, Inc. · 2012
  • K090104Liaison 25 OH Vitamin D Total Calibration Verifiers, Model: 310603DiaSorin, Inc. · 2009

More from Biokit, S.A.

23 FDA decisions under this applicant name. See the company

  • K243575ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG ControlsBiokit, S.A. · 2025
  • K233605ADVIA Centaur EBV-EBNA IgGBiokit, S.A. · 2024
  • K233606ADVIA Centaur EBV-VCA IgMBiokit, S.A. · 2024
  • K213987ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG ControlsBiokit, S.A. · 2023
  • K214068Quantia IgEBiokit, S.A. · 2023

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/K110619 · printed Nov 6, 2026

Cite this page

510(k) Report. “K110619: Architect 25-OH Vitamin D 100T, Vitamin D 500T, Vitamin D Calibrators, Vitamin D Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110619

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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