510(k) Report

510(k) · Cleared

Cleared

ALFIS Vitamin D, ALFIS-3 Analyzer

K221817510(k) TraditionalCleared Sep 22, 2023457-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

Immunostics Inc., · MRG System, Test, Vitamin D

Cleared on Sep 22, 2023 as substantially equivalent to K210901 (Roche Diagnostics, 2021) after a 457-day review. Its family tree reaches back 10 generations to 1993.

Decided
Sep 22, 2023
Review
457 days
Class
Class II
Product code
MRG
Recalls
None
Predicates
1

Its longest line of descent runs back 10 generations to K931172 (1993). 28 ancestors in all, the oldest K900779 (1990). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2011: 3 other ancestors2010: 2 other ancestors2007: 1 other ancestor2004: 3 other ancestors2003: 2 other ancestors1996: 2 other ancestors1997: 1 other ancestor1992: 1 other ancestor2002: 1 other ancestor1990: 1 other ancestor2000: 1 other ancestorK931172 · Imx (R) Stat CK-MB · Abbott Laboratories · 1993×2: 2 generations cleared close together, K961501 (1996), K962575 (1996) K983492 · Boehringer Mannheim Elecsys Presicontrol Cardiac · Boehringer Mannheim Corp. · 1998K032089 · Roche Diagnostics Elecsys Precicontrol Cardiac · Roche Diagnostics Corp. · 2003K033937 · Elecsys Precicontrol Multianalyte · Roche Diagnostics Corp. · 2004K102157 · Elecsys Precicontrol Multimarker · Roche Diagnostics · 2010K113546 · Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys Vitamin D Calcheck 5 · Roche Diagnostics · 2012K162840 · Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5 · Roche Diagnostics · 2017 · recalledK210901 · Elecsys Vitamin D total III · Roche Diagnostics · 202119901995200020052010201520202025
Other ancestors, by generation 4 generations back: 3 other ancestors5 generations back: 4 other ancestors6 generations back: 4 other ancestors7 generations back: 3 other ancestors8 generations back: 2 other ancestors9 generations back: 2 other ancestors K210901 · Elecsys Vitamin D total III · Roche Diagnostics · 2021K162840 · Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5 · Roche Diagnostics · 2017 · recalledK113546 · Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys Vitamin D Calcheck 5 · Roche Diagnostics · 2012K102157 · Elecsys Precicontrol Multimarker · Roche Diagnostics · 2010K033937 · Elecsys Precicontrol Multianalyte · Roche Diagnostics Corp. · 2004K032089 · Roche Diagnostics Elecsys Precicontrol Cardiac · Roche Diagnostics Corp. · 2003K983492 · Boehringer Mannheim Elecsys Presicontrol Cardiac · Boehringer Mannheim Corp. · 1998K962575 · Elecsys Precicontrol Cardiac · Boehringer Mannheim Corp. · 1996K961501 · Elecsys CK-MB · Boehringer Mannheim Corp. · 1996K931172 · Imx (R) Stat CK-MB · Abbott Laboratories · 1993−10−50
  1. Root · 10 generations backK931172 Imx (R) Stat CK-MBAbbott Laboratories · 1993
  2. 6 generations between
  3. 3 generations backK113546 Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys…Roche Diagnostics · 2012
  4. 2 generations backK162840 Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl…Roche Diagnostics · 2017 · Recalled
  5. 1 generation backK210901 Elecsys Vitamin D total IIIRoche Diagnostics · 2021
  6. This deviceK221817 ALFIS Vitamin D, ALFIS-3 AnalyzerImmunostics Inc., · 2023
Show all 10 generations
  1. Root · 10 generations backK931172 Imx (R) Stat CK-MBAbbott Laboratories · 1993
  2. 9 generations backK961501 Elecsys CK-MBBoehringer Mannheim Corp. · 1996
  3. 8 generations backK962575 Elecsys Precicontrol CardiacBoehringer Mannheim Corp. · 1996
  4. 7 generations backK983492 Boehringer Mannheim Elecsys Presicontrol CardiacBoehringer Mannheim Corp. · 1998
  5. 6 generations backK032089 Roche Diagnostics Elecsys Precicontrol CardiacRoche Diagnostics Corp. · 2003
  6. 5 generations backK033937 Elecsys Precicontrol MultianalyteRoche Diagnostics Corp. · 2004
  7. 4 generations backK102157 Elecsys Precicontrol MultimarkerRoche Diagnostics · 2010
  8. 3 generations backK113546 Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys…Roche Diagnostics · 2012
  9. 2 generations backK162840 Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl…Roche Diagnostics · 2017 · Recalled
  10. 1 generation backK210901 Elecsys Vitamin D total IIIRoche Diagnostics · 2021
  11. This deviceK221817 ALFIS Vitamin D, ALFIS-3 AnalyzerImmunostics Inc., · 2023
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K931172Imx (R) Stat CK-MBAbbott Laboratories1993—
−9K961501Elecsys CK-MBBoehringer Mannheim Corp.1996—
−8K962575Elecsys Precicontrol CardiacBoehringer Mannheim Corp.1996—
−7K983492Boehringer Mannheim Elecsys Presicontrol CardiacBoehringer Mannheim Corp.1998—
−6K032089Roche Diagnostics Elecsys Precicontrol CardiacRoche Diagnostics Corp.2003—
−5K033937Elecsys Precicontrol MultianalyteRoche Diagnostics Corp.2004—
−4K102157Elecsys Precicontrol MultimarkerRoche Diagnostics2010—
−3K113546Elecsys 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
−1K210901Elecsys Vitamin D total IIIRoche Diagnostics2021—
0 (this device)K221817ALFIS Vitamin D, ALFIS-3 AnalyzerImmunostics Inc.,2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199210
199620
199710
200010
200210
200320
200430
200710
201020
201130
FIG. 1 — Lineage of K221817, 1993–2023Source: 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 K232587 MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto…score 8.7 · 6 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
*K210901Elecsys Vitamin D total III
Summary page 5
…Sandhofer Strasse 116 Mannheim Baden-Wurttenberg, DE D-68305 Predicate Device ‘K’ Number : K210901 Predicate Device Product Code: MRG, Vitamin D Test System Intended use of ALFIS Vitamin D: ALFIS Vitamin D in conjunction with…
Roche Diagnostics2021—

What descends from it?

No later submission names this one as a predicate yet.

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 30 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
  • 3 of the 28 ancestors have a recall of any class.

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. 2023, 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?

ALFIS Vitamin D in conjunction with ALFIS-3 Analyzer is an enzyme-linked fluorescence immunoassay intended for in vitro diagnostic use at clinical laboratories for the quantitative measurement of Total 25-hydroxy Vitamin D (25-OH Vitamin D) in human serum, lithium heparin plasma and sodium heparin plasma. ALFIS Vitamin D is indicated to be used as an aid in the determination of Vitamin D sufficiency in adults. ALFIS-3 Analyzer is a fluorescence-scanning…

Read the full statement (103 words)

ALFIS Vitamin D in conjunction with ALFIS-3 Analyzer is an enzyme-linked fluorescence immunoassay intended for in vitro diagnostic use at clinical laboratories for the quantitative measurement of Total 25-hydroxy Vitamin D (25-OH Vitamin D) in human serum, lithium heparin plasma and sodium heparin plasma.

ALFIS Vitamin D is indicated to be used as an aid in the determination of Vitamin D sufficiency in adults.

ALFIS-3 Analyzer is a fluorescence-scanning instrument using magnetic beads and alkaline phosphatase enzyme system for in vitro diagnostic use in conjunction with various ALFIS immunoassays intended for measuring the concentration of designated analytes in human blood and other specimens.

Indications for use as stated in the FDA summary.

More from Immunostics Inc.,

14 FDA decisions under this applicant name. See the company

  • K182298hemochroma PLUS SystemImmunostics Inc., · 2018
  • K163465hemochroma PLUS SystemImmunostics Inc., · 2017
  • K163225AFIAS iFOB with AFIAS-50Immunostics Inc., · 2017
  • K171484hema-screen SPECIFIC GoldImmunostics Inc., · 2017
  • K163554hema-screen ER XCEL Enhanced Readability Fecal Occult Blood TestImmunostics Inc., · 2017

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
  • 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
  • K191499MAGLUMI 2000 25-OH Vitamin DShenzhen New Industries Biomedical Engineering Co., Ltd. · 2019

https://510kreport.com/device/K221817 · printed Nov 6, 2026

Cite this page

510(k) Report. “K221817: ALFIS Vitamin D, ALFIS-3 Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221817

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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