510(k) · Cleared

Recalled · Class III · 2014

Vitros Immunodiagnostic Products 25-OH Vitamin D Total Reagent Pack, Vitamin D Total Calibrators

K121608510(k) TraditionalCleared Feb 15, 2013259-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

Ortho-Clinical Diagnostics, Inc. · MRG System, Test, Vitamin D

Cleared on Feb 15, 2013 as substantially equivalent to K091849 (Immunodiagnostic Systems, Inc., 2010) after a 259-day review. Its family tree reaches back 1 generation to 2010. It has been recalled once.

Decided: Feb 15, 2013
Review: 259 days
Class: Class II
Product code: MRG
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K091849 (2010). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK091849 Ids-Isys 25-Hydroxy Vitamin D Assay, Ids-Isys 25-Hydroxy Vitamin D…Immunodiagnostic Systems, Inc. · 2010
This deviceK121608 Vitros Immunodiagnostic Products 25-OH Vitamin D Total Reagent Pack…Ortho-Clinical Diagnostics, Inc. · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K091849	Ids-Isys 25-Hydroxy Vitamin D Assay, Ids-Isys 25-Hydroxy Vitamin D Control Set	Immunodiagnostic Systems, Inc.	2010	—
0 (this device)	K121608	Vitros Immunodiagnostic Products 25-OH Vitamin D Total Reagent Pack, Vitamin D…	Ortho-Clinical Diagnostics, Inc.	2013	—

FIG. 1 — Lineage of K121608, 2010–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K221817 ALFIS Vitamin D, ALFIS-3 Analyzerscore 8.8 · 10 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K091849	Ids-Isys 25-Hydroxy Vitamin D Assay, Ids-Isys 25-Hydroxy Vitamin D Control Set Summary page 4 …ROS" Immunodiagnostic Products 25-OH Vitamin D Total Assay CONFIDENTIAL AND PROPRIETARY Traditional 510(k) b. Predicate 510(k) number(s) (K091 849) c. Comparison with predicate: The VITROS Inmmodiagnostic Products 25-OH Vitamin D Total Reagent Pack and…	Immunodiagnostic Systems, Inc.	2010	—

Also cleared against K091849: 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

Date	Class	Recall	Root cause	Reason
Jan 15, 2014	Class III	Z-1193-2014	Component design/selection	Ortho Clinical Diagnostics has determined that the VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators, Lots 0091 through 0235, used with VITROS Immunodiagnostic Products 25-OH Vitamin D Total Reagent Packs, may generate…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
2 other devices also cite its predicate K091849.

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. 2013, this device’s year, is highlighted.

FDA decisions per year · MRG

1in 2024

2007high 7 (2013) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MRG

120in 2017

2007high 264 (2015) · low 120 (2017)2026

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

Recalls per year · MRG

2in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	1	0
2008	1	—	2	0
2009	0	—	0	1
2010	1	—	0	0
2011	3	227	0	1
2012	3	122	3	23
2013	7	231	1	21
2014	6	159	0	14
2015	3	264	0	18
2016	3	147	2	14
2017	3	120	0	21
2018	2	—	2	75
2019	1	—	0	38
2020	1	—	0	10
2021	1	—	0	15
2022	0	—	0	13
2023	2	—	0	22
2024	1	—	0	32
2025	0	—	2	29
2026	0	—	0	—

What is it indicated for?

VITROS* Immunodiagnostic Products 25-OH Vitamin D Total Reagent Pack: For in vitro diagnostic use only For the quantitative measurement of total 25-OH vitamin D in human serum using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. The results of the VITROS 25-OH Vitamin D Total assay are used in the assessment of Vitamin D sufficiency. Assay results may be used in conjunction…

Read the full statement (131 words)

VITROS* Immunodiagnostic Products 25-OH Vitamin D Total Reagent Pack:

For in vitro diagnostic use only

For the quantitative measurement of total 25-OH vitamin D in human serum using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System.

The results of the VITROS 25-OH Vitamin D Total assay are used in the assessment of Vitamin D sufficiency. Assay results may be used in conjunction with other clinical or laboratory data to assist the clinician in patient management.

VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators:

For in vitro diagnostic use only.

For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic Systems and the VITROS 5600 Integrated System for the quantitative measurement of total 25-OH vitamin D in human serum.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K121608 · printed Nov 5, 2026

Cite this page

510(k) Report. “K121608: Vitros Immunodiagnostic Products 25-OH Vitamin D Total Reagent Pack, Vitamin D Total Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121608

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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