510(k) · Cleared
ClearedRoche Elecsys Folate RBC; Roche Elecsys Folate RBC Calset
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · CGN Acid, Folic, Radioimmunoassay
Cleared on May 12, 2011 as substantially equivalent to K082340 (Roche Diagnostics Corp., 2009) after a 142-day review. Its family tree reaches back 8 generations to 1993. 1 later device descends from it.
- Decided
- May 12, 2011
- Review
- 142 days
- Class
- Class II
- Product code
- CGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K931172 (1993). 20 ancestors in all, the oldest K924862 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK931172 Imx (R) Stat CK-MBAbbott Laboratories · 1993
- 7 generations backK961501 Elecsys CK-MBBoehringer Mannheim Corp. · 1996
- 6 generations backK962575 Elecsys Precicontrol CardiacBoehringer Mannheim Corp. · 1996
- 5 generations backK983492 Boehringer Mannheim Elecsys Presicontrol CardiacBoehringer Mannheim Corp. · 1998
- 4 generations backK032089 Roche Diagnostics Elecsys Precicontrol CardiacRoche Diagnostics Corp. · 2003
- 3 generations backK033937 Elecsys Precicontrol MultianalyteRoche Diagnostics Corp. · 2004
- 2 generations backK051517 Elecsys Precicontrol AnemiaRoche Diagnostics Corp. · 2005
- 1 generation backK082340 Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing…Roche Diagnostics Corp. · 2009
- This deviceK103716 Roche Elecsys Folate RBC; Roche Elecsys Folate RBC CalsetRoche Diagnostics · 2011
- Descendant · cites it directly · 0 of its ownK233060 Elecsys Folate IIIRoche Diagnostics · 2024
Most influential descendants
Showing 1 of 1 · See all- K233060Elecsys Folate IIIRoche Diagnostics · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K931172 | Imx (R) Stat CK-MB | Abbott Laboratories | 1993 | — |
| −7 | K961501 | Elecsys CK-MB | Boehringer Mannheim Corp. | 1996 | — |
| −6 | K962575 | Elecsys Precicontrol Cardiac | Boehringer Mannheim Corp. | 1996 | — |
| −5 | K983492 | Boehringer Mannheim Elecsys Presicontrol Cardiac | Boehringer Mannheim Corp. | 1998 | — |
| −4 | K032089 | Roche Diagnostics Elecsys Precicontrol Cardiac | Roche Diagnostics Corp. | 2003 | — |
| −3 | K033937 | Elecsys Precicontrol Multianalyte | Roche Diagnostics Corp. | 2004 | — |
| −2 | K051517 | Elecsys Precicontrol Anemia | Roche Diagnostics Corp. | 2005 | — |
| −1 | K082340 | Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing Reagent, Roche… | Roche Diagnostics Corp. | 2009 | — |
| 0 (this device) | K103716 | Roche Elecsys Folate RBC; Roche Elecsys Folate RBC Calset | Roche Diagnostics | 2011 | — |
| +1 | 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 |
|---|---|---|
| 2024 | 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? (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 |
|---|---|---|---|
| * | K082340 | Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing Reagent, Roche Elecsys…Summary page 3…ate RBC Test System is substantially equivalent to the equivalence Eleesys RBC Folate III Test System. This test system was previously cleared in K082340. Continued on next page... Page 3 of 8 Elecsys F… | 2009 |
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 |
|---|---|---|---|
| K233060 | Elecsys Folate III | 2024 | 0 |
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 18 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 20 ancestors has a recall of any class.
- Of its descendants, K233060 (Roche Diagnostics, 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K082340.
How does its category compare?
All CGN devicesCGN Acid, Folic, Radioimmunoassay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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) Eleesys Folate R-BC Assay: Measurements obtained by this device are used in the diagnosis and treatment of anemias on the Eleesys and cobas e immunoassay analyzers. For in vitro diagnostic use.
(2) Elecsys Folate RBC CalSet: Elecsys Folate RBC CalSet is used for calibrating the Elecsys Folate RBC assay on the Eleesys and cobas e immunmoassay analyzers. For in vitro diagnostic use.
(3) Eleesys Folate RBC CaiCheck: Eleesys Folate RBC CaiCheck is used for the verification of the calibration established by the Elecsys Folate RBC reagent on the indicated Elecsys and cobas e inmmoassay analyzers. For in vitro diagnostic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103716 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103716: Roche Elecsys Folate RBC; Roche Elecsys Folate RBC Calset.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103716
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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