510(k) · Cleared
ClearedAxsym Holo TC Reagent Kit, Model 3L83-20; Standard Calibrator Kit, Model 3L83-01; Control Kit, Model 3L83-10
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 Nov 22, 2006 as substantially equivalent to K030655 (Axis-Shield Biochemicals, Asa, 2004) after a 90-day review. Its family tree reaches back 2 generations to 1999. 5 later devices descend from it.
- Decided
- Nov 22, 2006
- Review
- 90 days
- Class
- Class II
- Product code
- CDD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K993571 (1999). 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK993571 Bayer Diagnostics Acs:180 VB12, Bayer Diagnostics Advia Centaue VB12Bayer Corp. · 1999
- 1 generation backK030655 Holotc RiaAxis-Shield Biochemicals, Asa · 2004
- This deviceK062467 Axsym Holo TC Reagent Kit, Model 3L83-20; Standard Calibrator Kit…Axis-Shield Diagnostics, Ltd. · 2006
- Descendant · cites it directly · 4 of its ownK112443 Architect Active B-12 (Holotranscobalamin)Axis-Shield Diagnostics, Ltd. · 2011
- Descendant · 2 generations on · 1 of its ownK160757 ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA…Axis-Shield Diagnostics Limited · 2016
- Descendant · 2 generations on · 0 of its ownK233541 ARCHITECT Active-B12 (Holotranscobalamin)Axis-Shield Diagnostics, Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK172133 ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) AssayAxis-Shield Diagnostics, Ltd. · 2017
- Descendant · 2 generations on · 0 of its ownK121946 Axis-Shield Acvtive-B12Axis-Shield Diagnostics, Ltd. · 2013
Most influential descendants
Showing 5 of 5 · See all- K112443Architect Active B-12 (Holotranscobalamin)Axis-Shield Diagnostics, Ltd. · 2011 · cites it directly4descendants
- K160757ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur…Axis-Shield Diagnostics Limited · 2016 · 2 generations on1descendant
- K233541ARCHITECT Active-B12 (Holotranscobalamin)Axis-Shield Diagnostics, Ltd. · 2024 · 2 generations on0descendants
- K172133ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) AssayAxis-Shield Diagnostics, Ltd. · 2017 · 3 generations on0descendants
- K121946Axis-Shield Acvtive-B12Axis-Shield Diagnostics, Ltd. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K993571 | Bayer Diagnostics Acs:180 VB12, Bayer Diagnostics Advia Centaue VB12 | Bayer Corp. | 1999 | — |
| −1 | K030655 | Holotc Ria | Axis-Shield Biochemicals, Asa | 2004 | — |
| 0 (this device) | 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 | — |
| +2 | K160757 | ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur… | Axis-Shield Diagnostics Limited | 2016 | — |
| +2 | K233541 | ARCHITECT Active-B12 (Holotranscobalamin) | Axis-Shield Diagnostics, Ltd. | 2024 | — |
| +3 | K172133 | ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay | Axis-Shield Diagnostics, Ltd. | 2017 | — |
| +2 | K121946 | Axis-Shield Acvtive-B12 | Axis-Shield Diagnostics, Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2024 | 1 | 0 |
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 |
|---|---|---|---|
| * | K030655 | Holotc RiaSummary page 1…Regulation: 862.1660 Device Classification: Class I Product Code: JJX Legally marketed device to which equivalency is claimed: Axis-Shield HoloTC Radioinmmnoassay (Kfi030655) AxSYM Il[olo IC Paige I of 3 5 10(k) Sumimary ADMIN 4.0 5 10O(k) Summary 15i August 20t)6 === Page 2… | 2004 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112443 | Architect Active B-12 (Holotranscobalamin) | 2011 | 4 |
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 7 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K112443 (Axis-Shield Diagnostics, Ltd., 2011) has gone furthest, with 4 descendants of its own.
How does its category compare?
All CDD devicesCDD Radioassay, Vitamin B12: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Reagents AxSYM HoloTC assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of holotranscobalamin (vitamin B12 bound to transcobalamin) in human serum and plasma on the AxSYM System. HoloTC is used as an aid in the diagnosis and treatment of vitamin B12 deficiency. Calibrators The AxSYM HoloTC Standard Calibrators are for the standard calibration of the AxSYM System when used for the quantitative determination of…
Read the full statement (114 words)
Reagents
AxSYM HoloTC assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of holotranscobalamin (vitamin B12 bound to transcobalamin) in human serum and plasma on the AxSYM System. HoloTC is used as an aid in the diagnosis and treatment of vitamin B12 deficiency.
Calibrators
The AxSYM HoloTC Standard Calibrators are for the standard calibration of the AxSYM System when used for the quantitative determination of holotranscobalmin (HoloTC) in human serum and plasma.
Controls
The AxSYM HoloTC Controls are for the use in quality control to monitor the accuracy and precision of the HoloTC assay when used for the quantitative determination of holotranscobalamin (HoloTC) in human serum and plasma on the AxSYM System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062467 · printed Nov 3, 2026
Cite this page
510(k) Report. “K062467: Axsym Holo TC Reagent Kit, Model 3L83-20; Standard Calibrator Kit, Model 3L83-01; Control Kit, Model 3L83-10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K062467
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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