510(k) · Cleared
ClearedARCHITECT Active-B12 (Holotranscobalamin)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axis-Shield Diagnostics, Ltd. · CDD Radioassay, Vitamin B12
Cleared on Jul 31, 2024 as substantially equivalent to K112443 (Axis-Shield Diagnostics, Ltd., 2011) after a 271-day review. Its family tree reaches back 4 generations to 1999.
- Decided
- Jul 31, 2024
- Review
- 271 days
- Class
- Class II
- Product code
- CDD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K993571 (1999). No later device cites it as a predicate yet.
- Root · 4 generations backK993571 Bayer Diagnostics Acs:180 VB12, Bayer Diagnostics Advia Centaue VB12Bayer Corp. · 1999
- 3 generations backK030655 Holotc RiaAxis-Shield Biochemicals, Asa · 2004
- 2 generations backK062467 Axsym Holo TC Reagent Kit, Model 3L83-20; Standard Calibrator Kit…Axis-Shield Diagnostics, Ltd. · 2006
- 1 generation backK112443 Architect Active B-12 (Holotranscobalamin)Axis-Shield Diagnostics, Ltd. · 2011
- This deviceK233541 ARCHITECT Active-B12 (Holotranscobalamin)Axis-Shield Diagnostics, Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K993571 | Bayer Diagnostics Acs:180 VB12, Bayer Diagnostics Advia Centaue VB12 | Bayer Corp. | 1999 | — |
| −3 | K030655 | Holotc Ria | Axis-Shield Biochemicals, Asa | 2004 | — |
| −2 | K062467 | Axsym Holo TC Reagent Kit, Model 3L83-20; Standard Calibrator Kit, Model… | Axis-Shield Diagnostics, Ltd. | 2006 | — |
| −1 | K112443 | Architect Active B-12 (Holotranscobalamin) | Axis-Shield Diagnostics, Ltd. | 2011 | — |
| 0 (this device) | K233541 | ARCHITECT Active-B12 (Holotranscobalamin) | Axis-Shield Diagnostics, Ltd. | 2024 | — |
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 K223289 Access Vitamin B12score 4.6 · 1 generation · no Class I recall
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 | Decided |
|---|---|---|---|
| * | K112443 | Architect Active B-12 (Holotranscobalamin)Summary page 5…Class II Classification Panel: Clinical Chemistry F. Legally marketed device to which equivalency is claimed: ARCHITECT Active-B12 (Holotranscobalamin), K112443. G. Description of Device: The ARCHITECT Active-B12 (Holotranscobalamin) assay is a two-step immunoassay for the quant… | 2011 |
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 25 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K112443.
How does its category compare?
All CDD devicesCDD Radioassay, Vitamin B12: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · CDD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CDD
147in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CDD
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CDD
44in 2025
MAUDE reports naming product code CDD, 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 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 4 |
| 2011 | 3 | 117 | 0 | 36 |
| 2012 | 3 | 147 | 0 | 23 |
| 2013 | 1 | — | 0 | 45 |
| 2014 | 2 | — | 0 | 12 |
| 2015 | 1 | — | 0 | 4 |
| 2016 | 2 | — | 0 | 6 |
| 2017 | 1 | — | 0 | 9 |
| 2018 | 0 | — | 2 | 15 |
| 2019 | 2 | — | 1 | 14 |
| 2020 | 0 | — | 0 | 11 |
| 2021 | 0 | — | 1 | 28 |
| 2022 | 1 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 27 |
| 2024 | 1 | — | 0 | 33 |
| 2025 | 0 | — | 0 | 44 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ARCHITECT Active-B12 (Holotranscobalamin) assay is a chemiluminescent microparticle immunoassay (CMIA)
for the quantitative determination of Holotranscobalamin in human serum on the ARCHITECT i System. Active-B12
(Holotranscobalamin) is used as an aid in the diagnosis and treatment of vitamin B12 deficiency
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233541 · printed Nov 4, 2026
Cite this page
510(k) Report. “K233541: ARCHITECT Active-B12 (Holotranscobalamin).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K233541
Report an extraction error
Are you the manufacturer?
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