510(k) · Cleared
Recalled · 2006Abbott Architect B12
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · LIG Radioassay, Intrinsic Factor Blocking Antibody
Cleared on Feb 3, 1999 after a 78-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Feb 3, 1999
- Review
- 78 days
- Class
- Class II
- Product code
- LIG
- Recalls
- 3
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK984108 Abbott Architect B12Abbott Laboratories · 1999
- Descendant · cites it directly · 0 of its ownK053330 Architect B12 CalibratorsAbbott Laboratories · 2005
Most influential descendants
Showing 1 of 1 · See all- K053330Architect B12 CalibratorsAbbott Laboratories · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K984108 | Abbott Architect B12 | Abbott Laboratories | 1999 | — |
| +1 | K053330 | Architect B12 Calibrators | Abbott Laboratories | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 LIG? 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 LIG device
- #1 K240800 Access Intrinsic Factor Abscore 7.6 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | — | AXSYM® B12 Assay Named without a submission number |
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 |
|---|---|---|---|
| K053330 | Architect B12 Calibrators | 2005 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 8, 2006 | Not classified | Z-0860-06 | Other | The 30-day onboard storage information is not included in the barcode labels for these two lots. As a result, the ARCHITECT system software is unable to track how long a reagent kit has been stored onboard the ARCHITECT instrument. |
| Aug 19, 2004 | Not classified | Z-1452-04 | Other | Changes in the ARCHITECT B12 Reagent lots may adversely affect the shape of the calibration curve, over time. These changes may produce controls out of range low and similar decreases in patient sample values prior to current expiration… |
| Dec 14, 2001 | Not classified | Z-0435-05 | Other | Falsely elevated B-hCG results can occur when running B12 and B-hCG assays on the same analyzer due to carryover. B-12 results are not impacted. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K053330 (Abbott Laboratories, 2005) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LIG devicesLIG Radioassay, Intrinsic Factor Blocking Antibody: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LIG
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LIG
Too few LIG 510(k)s in any year since 2007 to give a median.
Recalls per year · LIG
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LIG
1in 2019
MAUDE reports naming product code LIG, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Abbott ARCHITECT™ B12 assay is a Chemiluminescent Microparticle Intrinsic Factor assay for the quantitative determination of B12 in human serum and plasma on the Abbott ARCHITECT™ i System. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.
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/K984108 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984108: Abbott Architect B12.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984108
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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