510(k) · Cleared
ClearedLIAISON Vitamin B12
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DiaSorin, Inc. · CDD Radioassay, Vitamin B12
Cleared on Oct 2, 2019 as substantially equivalent to K140496 (Beckman Coulter, Inc., 2014) after a 62-day review. Its family tree reaches back 6 generations to 1993.
- Decided
- Oct 2, 2019
- Review
- 62 days
- Class
- Class II
- Product code
- CDD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K925637 (1993). 17 ancestors in all, the oldest K922823 (1992). No later device cites it as a predicate yet.
- Root · 6 generations backK925637 Access HTSH AssayBio-Rad Laboratories, Inc. · 1993
- 5 generations backK023093 Access Hypersensitive HTSH AssayBeckman Coulter, Inc. · 2002
- 4 generations backK042281 Modification to Access Hypersensitive HTSH AssayBeckman Coulter, Inc. · 2004
- 3 generations backK090588 Power Processor Sample Processing System with Generic Connection…Beckman Coulter, Inc. · 2009
- 2 generations backK110413 Power Processor Sample Processing System with Generic ConnectionsBeckman Coulter, Inc. · 2011 · Recalled
- 1 generation backK140496 Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate…Beckman Coulter, Inc. · 2014 · Recalled
- This deviceK192064 LIAISON Vitamin B12DiaSorin, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K925637 | Access HTSH Assay | Bio-Rad Laboratories, Inc. | 1993 | — |
| −5 | K023093 | Access Hypersensitive HTSH Assay | Beckman Coulter, Inc. | 2002 | — |
| −4 | K042281 | Modification to Access Hypersensitive HTSH Assay | Beckman Coulter, Inc. | 2004 | — |
| −3 | K090588 | Power Processor Sample Processing System with Generic Connection Module… | Beckman Coulter, Inc. | 2009 | — |
| −2 | K110413 | Power Processor Sample Processing System with Generic Connections | Beckman Coulter, Inc. | 2011 | 2 |
| −1 | K140496 | Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access… | Beckman Coulter, Inc. | 2014 | 4 |
| 0 (this device) | K192064 | LIAISON Vitamin B12 | DiaSorin, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K140496 | Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access…Summary page 4…dicate device used to demonstrate substantial equivalence to the LIAISON® Vitamin B12 assay is the Beckman Coulter Access Vitamin B12 assay previously FDA cleared under (K140496). 7. Device Description: The LIAISON® Vitamin B12 assay is a competitive chemiluminescence immunoassay (CLIA) for quantitative… | 2014 |
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 26 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 8 of the 17 ancestors have 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. 2019, 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 DiaSorin LIAISON® Vitamin B12 assay uses chemiluminescent immunoassay (CLIA) technology for the
quantitative determination of Vitamin B12 in human serum, SST serum and lithium heparin plasma. Measurements
obtained by this device are used in the diagnosis and treatment of anemia’s of gastrointestinal malabsorption. Assay
results should be used in conjunction with other clinical or laboratory data to assist the clinician in making individual
patient management decisions.
The assay must be performed on the LIAISON® XL Analyzer.
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/K192064 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192064: LIAISON Vitamin B12.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192064
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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