510(k) · Cleared
ClearedRoche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing Reagent, Roche Elecsys Folate Iii Calset, Roche Elecsys
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · CGN Acid, Folic, Radioimmunoassay
Cleared on Jun 19, 2009 as substantially equivalent to K043318 (Roche Diagnostics Corp., 2004) and 4 other predicates after a 308-day review. Its family tree reaches back 7 generations to 1993. 7 later devices descend from it.
- Decided
- Jun 19, 2009
- Review
- 308 days
- Class
- Class II
- Product code
- CGN
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K931172 (1993). 19 ancestors in all, the oldest K924862 (1992). 7 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK931172 Imx (R) Stat CK-MBAbbott Laboratories · 1993
- 6 generations backK961501 Elecsys CK-MBBoehringer Mannheim Corp. · 1996
- 5 generations backK962575 Elecsys Precicontrol CardiacBoehringer Mannheim Corp. · 1996
- 4 generations backK983492 Boehringer Mannheim Elecsys Presicontrol CardiacBoehringer Mannheim Corp. · 1998
- 3 generations backK032089 Roche Diagnostics Elecsys Precicontrol CardiacRoche Diagnostics Corp. · 2003
- 2 generations backK033937 Elecsys Precicontrol MultianalyteRoche Diagnostics Corp. · 2004
- 1 generation backK051517 Elecsys Precicontrol AnemiaRoche Diagnostics Corp. · 2005
- This deviceK082340 Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing…Roche Diagnostics Corp. · 2009
- Descendant · cites it directly · 3 of its ownK111506 Elecsys Precicontrol Varia 3Roche Diagnostics · 2011 · Recalled
- Descendant · 2 generations on · 2 of its ownK132828 Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys…Roche Diagnostics · 2013
- Descendant · cites it directly · 1 of its ownK103716 Roche Elecsys Folate RBC; Roche Elecsys Folate RBC CalsetRoche Diagnostics · 2011
- Descendant · 3 generations on · 0 of its ownK252431 Elecsys CalcitoninRoche Diagnostics GmbH · 2026
- Descendant · 2 generations on · 0 of its ownK233060 Elecsys Folate IIIRoche Diagnostics · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K111506Elecsys Precicontrol Varia 3Roche Diagnostics · 2011 · cites it directly3descendants
- K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3Roche Diagnostics · 2013 · 2 generations on2descendants
- K103716Roche Elecsys Folate RBC; Roche Elecsys Folate RBC CalsetRoche Diagnostics · 2011 · cites it directly1descendant
- K252431Elecsys CalcitoninRoche Diagnostics GmbH · 2026 · 3 generations on0descendants
- K233060Elecsys Folate IIIRoche Diagnostics · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K931172 | Imx (R) Stat CK-MB | Abbott Laboratories | 1993 | — |
| −6 | K961501 | Elecsys CK-MB | Boehringer Mannheim Corp. | 1996 | — |
| −5 | K962575 | Elecsys Precicontrol Cardiac | Boehringer Mannheim Corp. | 1996 | — |
| −4 | K983492 | Boehringer Mannheim Elecsys Presicontrol Cardiac | Boehringer Mannheim Corp. | 1998 | — |
| −3 | K032089 | Roche Diagnostics Elecsys Precicontrol Cardiac | Roche Diagnostics Corp. | 2003 | — |
| −2 | K033937 | Elecsys Precicontrol Multianalyte | Roche Diagnostics Corp. | 2004 | — |
| −1 | K051517 | Elecsys Precicontrol Anemia | Roche Diagnostics Corp. | 2005 | — |
| 0 (this device) | K082340 | Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing Reagent, Roche… | Roche Diagnostics Corp. | 2009 | — |
| +1 | K111506 | Elecsys Precicontrol Varia 3 | Roche Diagnostics | 2011 | 1 |
| +2 | K132828 | Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol… | Roche Diagnostics | 2013 | — |
| +1 | K103716 | Roche Elecsys Folate RBC; Roche Elecsys Folate RBC Calset | Roche Diagnostics | 2011 | — |
| +3 | K252431 | Elecsys Calcitonin | Roche Diagnostics GmbH | 2026 | — |
| +2 | K233060 | Elecsys Folate III | Roche Diagnostics | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 CGN? 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 CGN device
- #1 K233060 Elecsys Folate IIIscore 9.9 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K043318 | Modification to Roche Elecsys Folate II ImmunoassaySummary page 4…ystem. This test system includes the following 5 components which have been cleared under the following K numbers: 1) Elecsys Folate II (K043318) 2) Elecsys RBC Hemolyzing Reagent (K051292) 3) Elecsys Folate II CalSet II (K042490)… | 2004 |
| * | K051292 | Elecsys RBC Folate Hemolyzed ReagentSummary page 4…which have been cleared under the following K numbers: 1) Elecsys Folate II (K043318) 2) Elecsys RBC Hemolyzing Reagent (K051292) 3) Elecsys Folate II CalSet II (K042490) 4) Elecsys Folate II CalCheck II (K043320)… | 2005 |
| * | K042490 | Elecsys Folate II Calset IISummary page 4…ng K numbers: 1) Elecsys Folate II (K043318) 2) Elecsys RBC Hemolyzing Reagent (K051292) 3) Elecsys Folate II CalSet II (K042490) 4) Elecsys Folate II CalCheck II (K043320) 5) Elecsys PreciControl Anemia (KO51517)… | 2004 |
| * | K043320 | Modification to Roche Elecsys Folate II Calcheck IISummary page 4…8) 2) Elecsys RBC Hemolyzing Reagent (K051292) 3) Elecsys Folate II CalSet II (K042490) 4) Elecsys Folate II CalCheck II (K043320) 5) Elecsys PreciControl Anemia (KO51517) (The original Elecsys Folate Assay was cleared under K… | 2004 |
| * | K051517 | Elecsys Precicontrol AnemiaSummary page 11…icate Elecsys PreciControl Anemia __ __ __ __ _ (K051517) Intended Use Elecsys PreciControl Anemia is Elecsys PreciControl Anemia is used for qual… | 2005 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 19 ancestors has a recall of any class.
- Of its descendants, K111506 (Roche Diagnostics, 2011) has gone furthest, with 3 descendants of its own.
How does its category compare?
All CGN devicesCGN Acid, Folic, Radioimmunoassay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · CGN
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CGN
Too few CGN 510(k)s in any year since 2007 to give a median.
Recalls per year · CGN
3in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CGN
9in 2025
MAUDE reports naming product code CGN, 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 | 0 | — | 2 | 26 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 2 | — | 1 | 3 |
| 2010 | 1 | — | 1 | 0 |
| 2011 | 1 | — | 0 | 28 |
| 2012 | 0 | — | 2 | 11 |
| 2013 | 0 | — | 1 | 2 |
| 2014 | 1 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 1 | — | 2 | 2 |
| 2019 | 0 | — | 3 | 1 |
| 2020 | 1 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 13 |
| 2023 | 1 | — | 0 | 8 |
| 2024 | 1 | — | 0 | 19 |
| 2025 | 0 | — | 0 | 9 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
(1) Elecsys Folate III: Binding assay for the in vitro quantitative determination of folate in human serum and plasma. The binding assay is intended for use on Elecsys and cobas e immunoassay analyzers. Measurements obtained by these devices are used in the diagnosis and treatment of anemias. For in vitro diagnostic use. (2) Eleesys RBC Folate Hemolyzing Reagent: Elecsys RBC Folate Hemolyzing Reagent is used together with the Elecsys Folate III assay for…
Read the full statement (211 words)
(1) Elecsys Folate III: Binding assay for the in vitro quantitative determination of folate in human serum and plasma. The binding assay is intended for use on Elecsys and cobas e immunoassay analyzers. Measurements obtained by these devices are used in the diagnosis and treatment of anemias. For in vitro diagnostic use.
(2) Eleesys RBC Folate Hemolyzing Reagent: Elecsys RBC Folate Hemolyzing Reagent is used together with the Elecsys Folate III assay for the quantitative determination of folate in erthrocytes (RBC (red blood cell) folate). Binding assay for the in vitro quantitative determination of folate in human serum and plasma. The binding assay is intended for use on Elecsys and cobas e immunoassay analyzers. Measurements obtained by these devices are used in the diagnosis and treatment of anemias.
(3) Elecsys Folate III CalSet: Elecsys Folate III CalSet is used for calibrating the quantitative Elecsys Folate III assay on the Elecsys and cobas e immunoassay analyzers.
(4) Elecsys Folate III Ca!Check: Elecsys Folate III CalCheck is used for the verification of the calibration established by the Elecsys.Folate III reagent on the indicated Elecsys and cobas e immunoassay analyzers.
(5) Elecsys PreciControl Anemia: Elecsys PreciControl Anemia is used for the quality control of specified Elecsys immunoassays on Elecsys and cobas e immunoassay analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082340 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082340: Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing Reagent, Roche Elecsys Folate Iii Calset, Roche Elecsys.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082340
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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