510(k) Report

510(k) · Cleared

Recalled · Class II · 2012

Octeia 25-Hydroxy Vitamin D

K021163510(k) TraditionalCleared May 10, 200229-day reviewClass II21 CFR 862.1825Recalls 2

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

Immunodiagnostic Systems, Ltd. · MRG System, Test, Vitamin D

Cleared on May 10, 2002 after a 29-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 11 later devices descend from it. It has been recalled 2 times.

Decided
May 10, 2002
Review
29 days
Class
Class II
Product code
MRG
Recalls
2
Predicates
0

11 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2013: 2 descendants cleared2015: 2 descendants cleared2012: 1 descendant cleared2011: 2 descendants cleared2014: 1 descendant cleared2017: 1 descendant cleared2020: 1 descendant cleared2018: 1 descendant cleared200020052010201520202025
  1. This deviceK021163 Octeia 25-Hydroxy Vitamin DImmunodiagnostic Systems, Ltd. · 2002
  2. Descendant · cites it directly · 3 of its ownK110586 Advia Centaur Vitamin D Total AssaySiemens Healthcare Diagnostics, Inc. · 2011 · Recalled
  3. Descendant · cites it directly · 2 of its ownK123660 25-OH Vitamin D ElisaEuroimmun US · 2013
  4. Descendant · 2 generations on · 1 of its ownK141114 Bioplex (R) 2200 25-OH Vitamin D Kit, Bioplex (R) 2200 25-OH Vitamin…Bio-Rad Laboratories · 2015
  5. Descendant · 2 generations on · 1 of its ownK133156 Advia Centaur Vitamin D Total (Vitd) Assay;Advia Centaur Vitd Total…Siemens Healthcare Diagnostics, Inc. · 2014
  6. Descendant · 3 generations on · 0 of its ownK200509 ADVIA Centaur Vitamin D Total (VitD)Siemens Healthcare Diagnostics, Inc. · 2020

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2011: 22012: 12013: 22014: 12015: 22017: 12018: 12020: 1
2011high 2 (2011) · low 0 (2016)2026

Most influential descendants

Showing 5 of 11 · See all
  • K110586Advia Centaur Vitamin D Total AssaySiemens Healthcare Diagnostics, Inc. · 2011 · cites it directly3descendants
  • K12366025-OH Vitamin D ElisaEuroimmun US · 2013 · cites it directly2descendants
  • K141114Bioplex (R) 2200 25-OH Vitamin D Kit, Bioplex (R) 2200 25-OH Vitamin D Calibrator Set…Bio-Rad Laboratories · 2015 · 2 generations on1descendant
  • K133156Advia Centaur Vitamin D Total (Vitd) Assay;Advia Centaur Vitd Total Calibrators,Quality…Siemens Healthcare Diagnostics, Inc. · 2014 · 2 generations on1descendant
  • K200509ADVIA Centaur Vitamin D Total (VitD)Siemens Healthcare Diagnostics, Inc. · 2020 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K021163Octeia 25-Hydroxy Vitamin DImmunodiagnostic Systems, Ltd.2002—
+1K110586Advia Centaur Vitamin D Total AssaySiemens Healthcare Diagnostics, Inc.20117
+1K12366025-OH Vitamin D ElisaEuroimmun US2013—
+2K141114Bioplex (R) 2200 25-OH Vitamin D Kit, Bioplex (R) 2200 25-OH Vitamin D…Bio-Rad Laboratories2015—
+2K133156Advia Centaur Vitamin D Total (Vitd) Assay;Advia Centaur Vitd Total…Siemens Healthcare Diagnostics, Inc.2014—
+3K200509ADVIA Centaur Vitamin D Total (VitD)Siemens Healthcare Diagnostics, Inc.2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201120
201210
201320
201410
201520
201710
201810
202010
FIG. 1 — Lineage of K021163, 2002–2020Source: 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 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K110586Advia Centaur Vitamin D Total AssaySiemens Healthcare Diagnostics, Inc.20113
K12366025-OH Vitamin D ElisaEuroimmun US20132
K14235125-Hydroxy Vitamin Ds EIAImmunodiagnostic Systems, Ltd.20150
K12336425OH Vitamin D Total Elisa TestDiasource Immunoassays, S.A.20130
K122420Diazyme 25-Hydroxy Vitamin D Eia Kit Diazyme 25-Hydroxy Vitamin D Eia Control Set DiaDiazyme Laboratories20120
K102432Diazyme 25-Hydroxy Vitamin D Assay Kit Model DZ688A, Diazyme 25-Hydroxy Vitamin D Assay…Diazyme Laboratories20110

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 7, 2012Class IIZ-0697-2013Nonconforming Material/ComponentImmunodiagnostic Systems is recalling the 25-Hydroxy Vitamin D EIA, AC-57F1 because the QC report was found to have an erroneous calibrator value assigned. The value of 24.4 ng/mL for calibrator 4 was stated on the QC report, however the…
Aug 2, 2008Not classifiedZ-0173-2009Nonconforming Material/ComponentA small number of customers have experienced low absorbance values when using kits from this batch.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K110586 (Siemens Healthcare Diagnostics, Inc., 2011) has gone furthest, with 3 descendants of its own.

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.

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 IDS OCTEIA® 25-Hydroxy Vitamin D kit is a enzymeimmunoassay intended for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated metabolites in human serum or plasma to be used in the assessment of vitamin D sufficiency.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Immunodiagnostic Systems, Ltd.

23 FDA decisions under this applicant name. See the company

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  • K200475IDS-iSYS Ostase BAPImmunodiagnostic Systems, Ltd. · 2020
  • K190121Ids SHBGImmunodiagnostic Systems, Ltd. · 2019
  • K161158IDS-iSYS Intact PTHNImmunodiagnostic Systems, Ltd. · 2017
  • K161831IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control SetImmunodiagnostic Systems, Ltd. · 2016

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/K021163 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021163: Octeia 25-Hydroxy Vitamin D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021163

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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