510(k) · Cleared
ClearedAccess Vitamin B12 Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories, Inc. · CDD Radioassay, Vitamin B12
Cleared on Nov 5, 1993 after a 130-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.
- Decided
- Nov 5, 1993
- Review
- 130 days
- Class
- Class II
- Product code
- CDD
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK933142 Access Vitamin B12 AssayBio-Rad Laboratories, Inc. · 1993
- Descendant · cites it directly · 0 of its ownK013899 Vitros Immunodiagnostic Products Vitamin B12, Reagent Pack 1/2…Ortho-Clinical Diagnostics · 2002 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K013899Vitros Immunodiagnostic Products Vitamin B12, Reagent Pack 1/2, Folate Reagent Pack 3…Ortho-Clinical Diagnostics · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K933142 | Access Vitamin B12 Assay | Bio-Rad Laboratories, Inc. | 1993 | — |
| +1 | K013899 | Vitros Immunodiagnostic Products Vitamin B12, Reagent Pack 1/2, Folate Reagent… | Ortho-Clinical Diagnostics | 2002 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013899 | Vitros Immunodiagnostic Products Vitamin B12, Reagent Pack 1/2, Folate Reagent Pack 3… | 2002 | 0 |
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, K013899 (Ortho-Clinical Diagnostics, 2002) has gone furthest, with 0 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 | — |
https://510kreport.com/device/K933142 · printed Nov 6, 2026
Cite this page
510(k) Report. “K933142: Access Vitamin B12 Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K933142
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026