510(k) · Cleared
ClearedElecsys Folate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · CDD Radioassay, Vitamin B12
Cleared on Nov 12, 1997 as substantially equivalent to K935286 (Bio-Rad, 1994) after a 47-day review. Its family tree reaches back 1 generation to 1994. 10 later devices descend from it.
- Decided
- Nov 12, 1997
- Review
- 47 days
- Class
- Class II
- Product code
- CDD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K935286 (1994). 10 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK935286 Quantaphase II B12/FolateBio-Rad · 1994
- This deviceK973674 Elecsys FolateBoehringer Mannheim Corp. · 1997
- Descendant · cites it directly · 9 of its ownK031756 Roche Diagnostics Elecsys Folate II AssayRoche Diagnostics Corp. · 2003
- Descendant · 2 generations on · 8 of its ownK043318 Modification to Roche Elecsys Folate II ImmunoassayRoche Diagnostics Corp. · 2004 · Recalled
- Descendant · 3 generations on · 7 of its ownK082340 Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing…Roche Diagnostics Corp. · 2009
- Descendant · 4 generations on · 3 of its ownK111506 Elecsys Precicontrol Varia 3Roche Diagnostics · 2011 · Recalled
- Descendant · 5 generations on · 2 of its ownK132828 Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys…Roche Diagnostics · 2013
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K031756Roche Diagnostics Elecsys Folate II AssayRoche Diagnostics Corp. · 2003 · cites it directly9descendants
- K043318Modification to Roche Elecsys Folate II ImmunoassayRoche Diagnostics Corp. · 2004 · 2 generations on8descendants
- K082340Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing Reagent, Roche Elecsys…Roche Diagnostics Corp. · 2009 · 3 generations on7descendants
- K111506Elecsys Precicontrol Varia 3Roche Diagnostics · 2011 · 4 generations on3descendants
- K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3Roche Diagnostics · 2013 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K935286 | Quantaphase II B12/Folate | Bio-Rad | 1994 | — |
| 0 (this device) | K973674 | Elecsys Folate | Boehringer Mannheim Corp. | 1997 | — |
| +1 | K031756 | Roche Diagnostics Elecsys Folate II Assay | Roche Diagnostics Corp. | 2003 | — |
| +2 | K043318 | Modification to Roche Elecsys Folate II Immunoassay | Roche Diagnostics Corp. | 2004 | 1 |
| +3 | K082340 | Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing Reagent, Roche… | Roche Diagnostics Corp. | 2009 | — |
| +4 | K111506 | Elecsys Precicontrol Varia 3 | Roche Diagnostics | 2011 | 1 |
| +5 | K132828 | Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol… | Roche Diagnostics | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K935286 | Quantaphase II B12/FolateSummary page 1…assay for the determination of FOLATE. Classification name: Folate Test System. We claim substantial equivalence to the Bio-Rad Quantaphase II® B12/FOLATE Radioassay (K935286). The Elecsys® test principle is based on the sandwich principle. Total duration of assay: 18 minutes. e 1st Incubation (9 min… | 1994 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031756 | Roche Diagnostics Elecsys Folate II Assay | 2003 | 9 |
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?
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 | — |
What is it indicated for?
Assay for the in vitro quantitative determination of folate in human serum.
The electrochemiluminescence assay “ECLIA” is intended for use on the Boehringer Mannheim Elecsys assay analyzers.
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/K973674 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973674: Elecsys Folate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973674
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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