510(k) Report

510(k) · Cleared

Cleared

Bayer Diagnostics Acs:180 VB12, Bayer Diagnostics Advia Centaue VB12

K993571510(k) TraditionalCleared Dec 16, 199956-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

Bayer Corp. · CDD Radioassay, Vitamin B12

Cleared on Dec 16, 1999 after a 56-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.

Decided
Dec 16, 1999
Review
56 days
Class
Class II
Product code
CDD
Recalls
None
Predicates
0

7 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2006: 1 descendant cleared2011: 1 descendant cleared2016: 1 descendant cleared2024: 1 descendant cleared2013: 1 descendant cleared2017: 1 descendant cleared1995200020052010201520202025
  1. This deviceK993571 Bayer Diagnostics Acs:180 VB12, Bayer Diagnostics Advia Centaue VB12Bayer Corp. · 1999
  2. Descendant · cites it directly · 6 of its ownK030655 Holotc RiaAxis-Shield Biochemicals, Asa · 2004
  3. Descendant · 2 generations on · 5 of its ownK062467 Axsym Holo TC Reagent Kit, Model 3L83-20; Standard Calibrator Kit…Axis-Shield Diagnostics, Ltd. · 2006
  4. Descendant · 3 generations on · 4 of its ownK112443 Architect Active B-12 (Holotranscobalamin)Axis-Shield Diagnostics, Ltd. · 2011
  5. Descendant · 4 generations on · 1 of its ownK160757 ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA…Axis-Shield Diagnostics Limited · 2016
  6. Descendant · 4 generations on · 0 of its ownK233541 ARCHITECT Active-B12 (Holotranscobalamin)Axis-Shield Diagnostics, Ltd. · 2024

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2004: 12006: 12011: 12013: 12016: 12017: 12024: 1
2004high 1 (2004) · low 0 (2005)2026

Most influential descendants

Showing 5 of 7 · See all
  • K030655Holotc RiaAxis-Shield Biochemicals, Asa · 2004 · cites it directly6descendants
  • K062467Axsym Holo TC Reagent Kit, Model 3L83-20; Standard Calibrator Kit, Model 3L83-01…Axis-Shield Diagnostics, Ltd. · 2006 · 2 generations on5descendants
  • K112443Architect Active B-12 (Holotranscobalamin)Axis-Shield Diagnostics, Ltd. · 2011 · 3 generations on4descendants
  • K160757ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur…Axis-Shield Diagnostics Limited · 2016 · 4 generations on1descendant
  • K233541ARCHITECT Active-B12 (Holotranscobalamin)Axis-Shield Diagnostics, Ltd. · 2024 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K993571Bayer Diagnostics Acs:180 VB12, Bayer Diagnostics Advia Centaue VB12Bayer Corp.1999—
+1K030655Holotc RiaAxis-Shield Biochemicals, Asa2004—
+2K062467Axsym Holo TC Reagent Kit, Model 3L83-20; Standard Calibrator Kit, Model…Axis-Shield Diagnostics, Ltd.2006—
+3K112443Architect Active B-12 (Holotranscobalamin)Axis-Shield Diagnostics, Ltd.2011—
+4K160757ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur…Axis-Shield Diagnostics Limited2016—
+4K233541ARCHITECT Active-B12 (Holotranscobalamin)Axis-Shield Diagnostics, Ltd.2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200610
201110
201310
201610
201710
202410
FIG. 1 — Lineage of K993571, 1999–2024Source: 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? (2)

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
*—ACS:180 VB12
Named without a submission number
—
*—ADVIA Centaur VB12
Named without a submission number
—

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K030655Holotc RiaAxis-Shield Biochemicals, Asa20046

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?

  • Of its descendants, K030655 (Axis-Shield Biochemicals, Asa, 2004) has gone furthest, with 6 descendants of its own.

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?

In vitro diagnostic use in the quantitative determination of vitamin B12 in serum,

heparinized plasma, or EDTA plasma using the ADVIA Centaur System.

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

More from Bayer Corp.

96 FDA decisions under this applicant name. See the company

  • K024062Ascensia Breeze Blood Glucose MeterBayer Corp. · 2003
  • K023944Bayer Diagnostics Clinitest Pregnancy TestBayer Corp. · 2003
  • K024017Bayer Advia Centaur Her-2/Neu AssayBayer Corp. · 20031 recall
  • K024234Ascensia Glucofacts; Ascensia Glucofacts ProfessionalBayer Corp. · 2003
  • K022288Complexed Prostate Specific Antigen (Cpsa) Assay for the Bayer Advia Integrated Module SystemBayer Corp. · 2002

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/K993571 · printed Nov 6, 2026

Cite this page

510(k) Report. “K993571: Bayer Diagnostics Acs:180 VB12, Bayer Diagnostics Advia Centaue VB12.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993571

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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