510(k) · Cleared
ClearedArchitect B12 Reagents, Architect B12 Calibrators, and Architect B12 Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · CDD Radioassay, Vitamin B12
Cleared on Oct 6, 2011 as substantially equivalent to K060755 (Roche Diagnostics Corp., 2006) after a 219-day review. Its family tree reaches back 4 generations to 1992. 1 later device descends from it.
- Decided
- Oct 6, 2011
- Review
- 219 days
- Class
- Class II
- Product code
- CDD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K924862 (1992). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK924862 Aia-Pack HCG Calibration Verification Test SetTosoh Medics, Inc. · 1992
- 3 generations backK963147 Elecsys Calcheck TSHBoehringer Mannheim Corp. · 1996
- 2 generations backK974383 Elecsys Calcheck Vitamin B12Boehringer Mannheim Corp. · 1997
- 1 generation backK060755 Elecsys Vitamin B12 Immunoassay, Calset II and CalcheckRoche Diagnostics Corp. · 2006
- This deviceK110579 Architect B12 Reagents, Architect B12 Calibrators, and Architect B12…Abbott Laboratories · 2011
- Descendant · cites it directly · 0 of its ownK121314 Architect B12Abbott Laboratories · 2012
Most influential descendants
Showing 1 of 1 · See all- K121314Architect B12Abbott Laboratories · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K924862 | Aia-Pack HCG Calibration Verification Test Set | Tosoh Medics, Inc. | 1992 | — |
| −3 | K963147 | Elecsys Calcheck TSH | Boehringer Mannheim Corp. | 1996 | — |
| −2 | K974383 | Elecsys Calcheck Vitamin B12 | Boehringer Mannheim Corp. | 1997 | — |
| −1 | K060755 | Elecsys Vitamin B12 Immunoassay, Calset II and Calcheck | Roche Diagnostics Corp. | 2006 | — |
| 0 (this device) | K110579 | Architect B12 Reagents, Architect B12 Calibrators, and Architect B12 Controls | Abbott Laboratories | 2011 | — |
| +1 | K121314 | Architect B12 | Abbott Laboratories | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 |
|---|---|---|---|
| * | K060755 | Elecsys Vitamin B12 Immunoassay, Calset II and CalcheckSummary page 2…Page I of 3 5 [0(k) summary Levzallv Marketed Device to Which Equivalence is Claimed Roche Elecsys Vitamin 1312 Immunoassay (K060755) Intended Use of Device The ARCHITECT B 12 assay is a chemiluminescent microparticle Intrinsic Factor assay f… | 2006 |
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 |
|---|---|---|---|
| K121314 | Architect B12 | 2012 | 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?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 5.5 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K121314 (Abbott Laboratories, 2012) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K060755.
How does its category compare?
All CDD devicesCDD Radioassay, Vitamin B12: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 B12 assay is a chemi luminescent microparticle Intrinsic Factor assay for the quantitative determination of vitamin B12 in human serum on the ARCHITECT i System. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption. The ARCHITECT B 12 Controls are used for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System when…
Read the full statement (123 words)
The ARCHITECT B12 assay is a chemi luminescent microparticle Intrinsic Factor assay for the quantitative determination of vitamin B12 in human serum on the ARCHITECT i System. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.
The ARCHITECT B 12 Controls are used for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System when used for the quantitative determination of vitamin B12 in human serum when using the ARCHITECT B12 Reagent Kit.
The ARCHITECT B 12 Calibrators are used to calibrate the ARCHITECT i System when the system is used for the quantitative determination of vitamin B12 in human serum using the ARCHITECT B 12 Reagent Kit.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110579 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110579: Architect B12 Reagents, Architect B12 Calibrators, and Architect B12 Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110579
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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