510(k) Report

510(k) · Cleared

Cleared

Elecsys Vitamin B12 Assay

K973702510(k) TraditionalCleared Nov 13, 199748-day reviewClass II21 CFR 862.1810

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

Boehringer Mannheim Corp. · CDD Radioassay, Vitamin B12

Cleared on Nov 13, 1997 as substantially equivalent to K935286 (Bio-Rad, 1994) after a 48-day review. Its family tree reaches back 1 generation to 1994. 10 later devices descend from it.

Decided
Nov 13, 1997
Review
48 days
Class
Class II
Product code
CDD
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K935286 (1994). 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 clearedK935286 · Quantaphase II B12/Folate · Bio-Rad · 19941990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 4 descendants3 generations forward: 3 descendants4 generations forward: 2 descendants K935286 · Quantaphase II B12/Folate · Bio-Rad · 19940
  1. Root · 1 generation backK935286 Quantaphase II B12/FolateBio-Rad · 1994
  2. This deviceK973702 Elecsys Vitamin B12 AssayBoehringer Mannheim Corp. · 1997
  3. Descendant · cites it directly · 9 of its ownK060755 Elecsys Vitamin B12 Immunoassay, Calset II and CalcheckRoche Diagnostics Corp. · 2006
  4. Descendant · 2 generations on · 3 of its ownK140505 Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master…Siemens Healthcare Diagnostics, Inc. · 2014
  5. Descendant · 3 generations on · 2 of its ownK151986 ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II…Siemens Healthcare Diagnostics, Inc. · 2016
  6. Descendant · 2 generations on · 1 of its ownK121994 Dimension Vista Vitamin B12 (VB12) Flex Reagent Cartridge, Dimension…Siemens Healthcare Diagnostics, Inc. · 2012
  7. 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
−1K935286Quantaphase II B12/FolateBio-Rad1994—
0 (this device)K973702Elecsys Vitamin B12 AssayBoehringer 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 K973702, 1994–2019Source: 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 CDD? 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 CDD device

  1. #1 K233541 ARCHITECT Active-B12 (Holotranscobalamin)score 8.7 · 4 generations · no Class I recall
  2. #2 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
*K935286Quantaphase II B12/Folate
Summary page 1
…oducts in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed BioRad Quantaphase II B12/Folate Assay (K935286). Continued on next page page 26 CORPORATION 4. Device Description Competition principle. Total duration of a…
Bio-Rad1994—

Also cleared against K935286: 4 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?

  • Its one ancestor has no recall.
  • Of its descendants, K060755 (Roche Diagnostics Corp., 2006) has gone furthest, with 9 descendants of its own.
  • 4 other devices also cite its predicate K935286.

How does its category compare?

All CDD devices

CDD Radioassay, Vitamin B12: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CDD

1in 2024

2007: 12009: 12010: 12011: 32012: 32013: 12014: 22015: 12016: 22017: 12019: 22022: 12024: 1
2007high 3 (2011) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CDD

147in 2012

2011: 117 days median2012: 147 days median
2007high 147 (2012) · low 117 (2011)2026

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

Recalls per year · CDD

1in 2021

2007: 12018: 22019: 12021: 1
2007high 2 (2018) · low 0 (2008)2026

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

Adverse event reports per year · CDD

44in 2025

2010: 42011: 362012: 232013: 452014: 122015: 42016: 62017: 92018: 152019: 142020: 112021: 282022: 242023: 272024: 332025: 44
2007high 45 (2013) · low 0 (2007)2025

MAUDE reports naming product code CDD, 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
20080—00
20091—00
20101—04
20113117036
20123147023
20131—045
20142—012
20151—04
20162—06
20171—09
20180—215
20192—114
20200—011
20210—128
20221—024
20230—027
20241—033
20250—044
20260—0—

What is it indicated for?

A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained with this device are used in the diagnosis and treatment of

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 K935286

4 other devices cite the same predicate.

  • K984166Vitros Immunodiagnostic Products Folate Reagent Pack 1/2, Vitros Immunodiagnostic Products Vitamin…Ortho-Clinical Diagnostics, Inc. · 19991 recall
  • K984321Vitros Immunodiagnostic Products Vitamin B12, Reagent Pack 1/2, Folate Reagent Pack 3, Anf CalibratorsOrtho-Clinical Diagnostics, Inc. · 19991 recall
  • K981931Cedia Red Blood Cell Folate Reagent Pack, Cedia Folate Assay and Elecsys Folate AssayRoche Diagnostics/Boehringer Mannheim GmbH · 1998
  • K973674Elecsys FolateBoehringer 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 CDD

The CDD category page

  • K233541ARCHITECT Active-B12 (Holotranscobalamin)Axis-Shield Diagnostics, Ltd. · 2024
  • K223289Access Vitamin B12Beckman Coulter, Inc. · 2022
  • K190298DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access…Beckman Coulter Biomedical GmbH · 20194 recalls
  • K192064LIAISON Vitamin B12DiaSorin, Inc. · 2019
  • K172133ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) AssayAxis-Shield Diagnostics, Ltd. · 2017

https://510kreport.com/device/K973702 · printed Nov 4, 2026

Cite this page

510(k) Report. “K973702: Elecsys Vitamin B12 Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973702

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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