510(k) · Cleared
ClearedArchitect B12
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 May 17, 2012 as substantially equivalent to K110579 (Abbott Laboratories, 2011) after a 15-day review. Its family tree reaches back 5 generations to 1992.
- Decided
- May 17, 2012
- Review
- 15 days
- Class
- Class II
- Product code
- CDD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K924862 (1992). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK924862 Aia-Pack HCG Calibration Verification Test SetTosoh Medics, Inc. · 1992
- 4 generations backK963147 Elecsys Calcheck TSHBoehringer Mannheim Corp. · 1996
- 3 generations backK974383 Elecsys Calcheck Vitamin B12Boehringer Mannheim Corp. · 1997
- 2 generations backK060755 Elecsys Vitamin B12 Immunoassay, Calset II and CalcheckRoche Diagnostics Corp. · 2006
- 1 generation backK110579 Architect B12 Reagents, Architect B12 Calibrators, and Architect B12…Abbott Laboratories · 2011
- This deviceK121314 Architect B12Abbott Laboratories · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K924862 | Aia-Pack HCG Calibration Verification Test Set | Tosoh Medics, Inc. | 1992 | — |
| −4 | K963147 | Elecsys Calcheck TSH | Boehringer Mannheim Corp. | 1996 | — |
| −3 | K974383 | Elecsys Calcheck Vitamin B12 | Boehringer Mannheim Corp. | 1997 | — |
| −2 | K060755 | Elecsys Vitamin B12 Immunoassay, Calset II and Calcheck | Roche Diagnostics Corp. | 2006 | — |
| −1 | K110579 | Architect B12 Reagents, Architect B12 Calibrators, and Architect B12 Controls | Abbott Laboratories | 2011 | — |
| 0 (this device) | 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 |
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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K110579 | Architect B12 Reagents, Architect B12 Calibrators, and Architect B12 ControlsSummary page 2…JX Page I of 10 3. Predicate Device Abbott ARCH ITECT B 12 (kI 110579). 4. Intended Use of Device The ARCHITECT B112 assay is a chemi luminescent microparticle Intrinsic Factor assay for the… | 2011 |
| Kept off the family tree | K093401 | ARCHITECT B12 Calibrators Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 5…ARCHITECT B312 ARCHITECT B312 Characteristics (Plasma Claim) (k093401) The ARCHITECT B 12 The ARCHITECT B12 Calibrators… |
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 20 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 8 ancestors has a recall of any class.
How does its category compare?
All CDD devicesCDD Radioassay, Vitamin B12: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 chemiluminescent microparticle Intrinsic Factor assay for the quantitative determination of vitamin B 12 in human serum and plasma 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 Calibrators are used to calibrate the ARCHITECT iSystem when the system is used for the quantitative determination of vitamin B…
Read the full statement (129 words)
The ARCHITECT B12 assay is a chemiluminescent microparticle Intrinsic Factor assay for the quantitative determination of vitamin B 12 in human serum and plasma 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 Calibrators are used to calibrate the ARCHITECT iSystem when the system is used for the quantitative determination of vitamin B 12 in human serum and plasma using the ARCHITECT B 12 Reagent Kit.
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 serm and plasma when using the ARCHITECT B12 Reagent Kit.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121314 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121314: Architect B12.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121314
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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