510(k) · Cleared
ClearedAxis-Shield Acvtive-B12
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 Mar 22, 2013 as substantially equivalent to K112443 (Axis-Shield Diagnostics, Ltd., 2011) after a 262-day review. Its family tree reaches back 4 generations to 1999.
- Decided
- Mar 22, 2013
- Review
- 262 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 deviceK121946 Axis-Shield Acvtive-B12Axis-Shield Diagnostics, Ltd. · 2013
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) | K121946 | Axis-Shield Acvtive-B12 | Axis-Shield Diagnostics, Ltd. | 2013 | — |
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 K233541 ARCHITECT Active-B12 (Holotranscobalamin)score 8.7 · 4 generations · no Class I recall
- #2 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K112443 | Architect Active B-12 (Holotranscobalamin)Summary page 1…ass 11 Classification Panel: Clinical Chemistry Prod uct Code: CDD Legally marketed device to which equivalency is claimed: ARCHITECT Active-8312 (Holotranscobalamin) (K112443) Axis-Shield Active-B12 (Holotranscobalamin), Ki121946 510(k) Summary Final Page 1 o… | 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 14 years and passes through 3 companies; a new generation was cleared every 4.1 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. 2013, 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 Axis-Shield Active-B12 (Holotranscobalamin) assay is an enzyme-immunoassay
(EIA) for the quantitative determination of holotranscobalamin (HoloTC) in human
serum. HoloTC (vitamin B12 bound to transcobalamin) is used as an aid in the diagnosis
and treatment of vitamin B12 deficiency.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K121946 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121946: Axis-Shield Acvtive-B12.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121946
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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