510(k) Report

510(k) · Cleared

Recalled · Class II · 2018

ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls

K153375510(k) TraditionalCleared Aug 12, 2016263-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

Abbott Laboratories · MRG System, Test, Vitamin D

Cleared on Aug 12, 2016 as substantially equivalent to K110619 (Biokit, S.A., 2011) after a 263-day review. Its family tree reaches back 3 generations to 2004. It has been recalled once.

Decided
Aug 12, 2016
Review
263 days
Class
Class II
Product code
MRG
Recalls
1
Predicates
1

Its longest line of descent runs back 3 generations to K032844 (2004). No later device cites it as a predicate yet.

K032844 · 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. · 2007K110619 · Architect 25-OH Vitamin D 100T, Vitamin D 500T, Vitamin D Calibrators, Vitamin D Controls · Biokit, S.A. · 2011 · recalled2000200520102015
K110619 · Architect 25-OH Vitamin D 100T, Vitamin D 500T, Vitamin D Calibrators, Vitamin D Controls · Biokit, S.A. · 2011 · recalledK071480 · 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 · 3 generations backK032844 Liaison 25 OH Vitamin DDiaSorin, Inc. · 2004 · Recalled
  2. 2 generations backK071480 Liaison 25 OH Vitamin D Total; Assay, Control Set and Specimen…DiaSorin, Inc. · 2007
  3. 1 generation backK110619 Architect 25-OH Vitamin D 100T, Vitamin D 500T, Vitamin D…Biokit, S.A. · 2011 · Recalled
  4. This deviceK153375 ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02…Abbott Laboratories · 2016
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K032844Liaison 25 OH Vitamin DDiaSorin, Inc.20044
−2K071480Liaison 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
0 (this device)K153375ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators…Abbott Laboratories2016—
FIG. 1 — Lineage of K153375, 2004–2016Source: 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
*K110619Architect 25-OH Vitamin D 100T, Vitamin D 500T, Vitamin D Calibrators, Vitamin D Controls
Summary page 5
…me: Quality Control Material (assayed and unassayed) Governing Regulation: 862.1660 Code: JJX III. Predicate Device Reagents ARCHITECT 25-OH Vitamin D (k110619) Calibrators ARCHITECT 25-OH Vitamin D Calibrators (k110619) Controls ARCHITECT 25-OH Vitamin D Controls (k1106…
Biokit, S.A.20111

Also cleared against K110619: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 21, 2018Class IIZ-0669-2019Nonconforming Material/ComponentAbbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
  • 2 of the 3 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K110619.

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. 2016, 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 ARCHITECT 25-OH Vitamin D assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 25-hydroxyvitamin D (25 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. The ARCHITECT 25-OH Vitamin D Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of 25 hydroxyvitamin D…

Read the full statement (121 words)

The ARCHITECT 25-OH Vitamin D assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 25-hydroxyvitamin D (25 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.

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

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

Indications for use as stated in the FDA summary.

Also cleared against K110619

2 other devices cite the same predicate.

  • K162754FREND Vitamin D Test SystemNanoentek USA, Inc. · 2017
  • K113546Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys Vitamin D Calcheck 5Roche Diagnostics · 2012

More from Abbott Laboratories

1,433 FDA decisions under this applicant name. See the company

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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/K153375 · printed Nov 5, 2026

Cite this page

510(k) Report. “K153375: ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153375

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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