510(k) Report

510(k) · Cleared

Cleared

Elecsys Calcheck Vitamin B12

K974383510(k) TraditionalCleared Dec 8, 199717-day reviewClass I21 CFR 862.1660

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

Boehringer Mannheim Corp. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

Cleared on Dec 8, 1997 as substantially equivalent to K963147 (Boehringer Mannheim Corp., 1996) after a 17-day review. Its family tree reaches back 2 generations to 1992. 10 later devices descend from it.

Decided
Dec 8, 1997
Review
17 days
Class
Class I
Product code
JJX
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K924862 (1992). 10 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2011: 1 descendant cleared2014: 2 descendants cleared2012: 2 descendants cleared2015: 1 descendant cleared2016: 1 descendant cleared2019: 2 descendants clearedK924862 · Aia-Pack HCG Calibration Verification Test Set · Tosoh Medics, Inc. · 1992K963147 · Elecsys Calcheck TSH · Boehringer Mannheim Corp. · 19961990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 4 descendants3 generations forward: 3 descendants4 generations forward: 2 descendants K963147 · Elecsys Calcheck TSH · Boehringer Mannheim Corp. · 1996K924862 · Aia-Pack HCG Calibration Verification Test Set · Tosoh Medics, Inc. · 19920
  1. Root · 2 generations backK924862 Aia-Pack HCG Calibration Verification Test SetTosoh Medics, Inc. · 1992
  2. 1 generation backK963147 Elecsys Calcheck TSHBoehringer Mannheim Corp. · 1996
  3. This deviceK974383 Elecsys Calcheck Vitamin B12Boehringer Mannheim Corp. · 1997
  4. Descendant · cites it directly · 9 of its ownK060755 Elecsys Vitamin B12 Immunoassay, Calset II and CalcheckRoche Diagnostics Corp. · 2006
  5. Descendant · 2 generations on · 3 of its ownK140505 Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master…Siemens Healthcare Diagnostics, Inc. · 2014
  6. Descendant · 3 generations on · 2 of its ownK151986 ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II…Siemens Healthcare Diagnostics, Inc. · 2016
  7. Descendant · 2 generations on · 1 of its ownK121994 Dimension Vista Vitamin B12 (VB12) Flex Reagent Cartridge, Dimension…Siemens Healthcare Diagnostics, Inc. · 2012
  8. Descendant · 2 generations on · 1 of its ownK110579 Architect B12 Reagents, Architect B12 Calibrators, and Architect B12…Abbott Laboratories · 2011

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2006: 12011: 12012: 22014: 22015: 12016: 12019: 2
2006high 2 (2012) · low 0 (2007)2026

Most influential descendants

Showing 5 of 10 · See all
  • K060755Elecsys Vitamin B12 Immunoassay, Calset II and CalcheckRoche Diagnostics Corp. · 2006 · cites it directly9descendants
  • K140505Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master Curve Material, and…Siemens Healthcare Diagnostics, Inc. · 2014 · 2 generations on3descendants
  • K151986ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve…Siemens Healthcare Diagnostics, Inc. · 2016 · 3 generations on2descendants
  • K121994Dimension Vista Vitamin B12 (VB12) Flex Reagent Cartridge, Dimension Vista Loci 4…Siemens Healthcare Diagnostics, Inc. · 2012 · 2 generations on1descendant
  • K110579Architect B12 Reagents, Architect B12 Calibrators, and Architect B12 ControlsAbbott Laboratories · 2011 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K924862Aia-Pack HCG Calibration Verification Test SetTosoh Medics, Inc.1992—
−1K963147Elecsys Calcheck TSHBoehringer Mannheim Corp.1996—
0 (this device)K974383Elecsys Calcheck Vitamin B12Boehringer Mannheim Corp.1997—
+1K060755Elecsys Vitamin B12 Immunoassay, Calset II and CalcheckRoche Diagnostics Corp.2006—
+2K140505Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master Curve…Siemens Healthcare Diagnostics, Inc.2014—
+3K151986ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII)…Siemens Healthcare Diagnostics, Inc.2016—
+2K121994Dimension Vista Vitamin B12 (VB12) Flex Reagent Cartridge, Dimension Vista…Siemens Healthcare Diagnostics, Inc.2012—
+2K110579Architect B12 Reagents, Architect B12 Calibrators, and Architect B12 ControlsAbbott Laboratories2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
201110
201220
201420
201510
201610
201920
FIG. 1 — Lineage of K974383, 1992–2019Source: 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 JJX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin 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.

TypeNumberDeviceApplicantDecidedRecalls
*K963147Elecsys Calcheck TSH
Summary page 1
…ayed) The Boehringer Mannheim Elecsys® CalCheck™ Vitamin B12 is substantially equivalent to the currently marketed Elecsys® CalCheck™ TSH Calibration Verification Test (K963147). The Boehringer Mannheim Elecsys® CalCheck™ Vitamin B12 is manufactured using human serum albumin, vitamin B12, stabilizers, an…
Boehringer Mannheim Corp.1996—

Also cleared against K963147: 7 other devices →

What descends from it? (10)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K060755Elecsys Vitamin B12 Immunoassay, Calset II and CalcheckRoche Diagnostics Corp.20069

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 5 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K060755 (Roche Diagnostics Corp., 2006) has gone furthest, with 9 descendants of its own.
  • 7 other devices also cite its predicate K963147.

How does its category compare?

All JJX devices

JJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJX

2in 2017

2007: 62008: 82009: 172010: 242011: 192012: 152013: 192014: 222015: 112016: 62017: 2
2007high 24 (2010) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJX

31in 2016

2007: 53 days median2008: 52 days median2009: 80 days median2010: 80 days median2011: 62 days median2012: 40 days median2013: 37 days median2014: 30 days median2015: 65 days median2016: 31 days median
2007high 80 (2009) · low 30 (2014)2026

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

Recalls per year · JJX

1in 2021

2007: 32008: 32010: 32011: 22014: 12015: 12016: 22018: 22021: 1
2007high 3 (2007) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JJX

22in 2025

2007: 22009: 12010: 62011: 622012: 322013: 512014: 482015: 672016: 372017: 192018: 352019: 822020: 772021: 432022: 242023: 222024: 302025: 22
2007high 82 (2019) · low 0 (2008)2025

MAUDE reports naming product code JJX, 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
200765332
200885230
2009178001
2010248036
20111962262
20121540032
20131937051
20142230148
20151165167
2016631237
20172—019
20180—235
20190—082
20200—077
20210—143
20220—024
20230—022
20240—030
20250—022
20260—0—

What is it indicated for?

Elecsys CalCheck Vitamin B12 calibration verification solutions comprise three levels - low,

mid, and high - each with a defined Vitamin B12 concentration. The low solution concentration

is near the clinical deficiency range of the assay. The mid solution is in the middle point of the

measuring range. The high solution is near the upper limit of the measuring range.

The Elecsys CalCheck Vitamin B12 is intended for use in periodic verification of the calibration

of the Elecsys Vitamin B12 assay.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K963147

7 other devices cite the same predicate.

  • K093836Elecsys TSH Calcheck 5Roche Diagnostics · 2010
  • K020369Elecsys Anti-TG CalcheckRoche Diagnostics Corp. · 2002
  • K974384Elecsys Calcheck FolateBoehringer Mannheim Corp. · 1997
  • K973973Elecsys Callcheck DigoxinBoehringer Mannheim Corp. · 1997
  • K970452Elecsys Calcheck CeaBoehringer Mannheim Corp. · 1997
  • K970458Elecsys Calcheck PsaBoehringer Mannheim Corp. · 1997

More from Boehringer Mannheim Corp.

345 FDA decisions under this applicant name. See the company

  • K984326Elecys Ige AssayBoehringer Mannheim Corp. · 1999
  • K983047Accu-Chek HQ SystemBoehringer Mannheim Corp. · 19991 recall
  • K984419Elecsys Ige CalcheckBoehringer Mannheim Corp. · 1999
  • K984425Modification of Preciset Serum Proteins CalibratorBoehringer Mannheim Corp. · 1999
  • K984372Elecsys Calcheck Troponin TBoehringer Mannheim Corp. · 1998

Recent decisions in JJX

The JJX category page

  • K170678Beta-CrossLaps CalCheck 5Roche Diagnostics · 2017
  • K162173Elecsys CYFRA 21-1 CalCheck 5Roche Diagnostics · 2017
  • K162514Multichem A1cTechnopath Manufacturing · 2016
  • K161874Audit MicroControls Linearity DROP LQ Blood GlucoseAalto Scientific, Ltd. · 2016
  • K161522LIAISON EBV IgM Serum Control SetDiaSorin, Inc. · 2016

https://510kreport.com/device/K974383 · printed Nov 5, 2026

Cite this page

510(k) Report. “K974383: Elecsys Calcheck Vitamin B12.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974383

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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