510(k) · Cleared
ClearedElecsys Calcheck Folate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Dec 8, 1997 as substantially equivalent to K963147 (Boehringer Mannheim Corp., 1996) after a 17-day review. Its family tree reaches back 2 generations to 1992. 9 later devices descend from it.
- Decided
- Dec 8, 1997
- Review
- 17 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K924862 (1992). 9 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK924862 Aia-Pack HCG Calibration Verification Test SetTosoh Medics, Inc. · 1992
- 1 generation backK963147 Elecsys Calcheck TSHBoehringer Mannheim Corp. · 1996
- This deviceK974384 Elecsys Calcheck FolateBoehringer Mannheim Corp. · 1997
- Descendant · cites it directly · 8 of its ownK043320 Modification to Roche Elecsys Folate II Calcheck IIRoche Diagnostics Corp. · 2004
- Descendant · 2 generations on · 7 of its ownK082340 Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing…Roche Diagnostics Corp. · 2009
- Descendant · 3 generations on · 3 of its ownK111506 Elecsys Precicontrol Varia 3Roche Diagnostics · 2011 · Recalled
- Descendant · 4 generations on · 2 of its ownK132828 Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys…Roche Diagnostics · 2013
- Descendant · 3 generations on · 1 of its ownK103716 Roche Elecsys Folate RBC; Roche Elecsys Folate RBC CalsetRoche Diagnostics · 2011
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K043320Modification to Roche Elecsys Folate II Calcheck IIRoche Diagnostics Corp. · 2004 · cites it directly8descendants
- K082340Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing Reagent, Roche Elecsys…Roche Diagnostics Corp. · 2009 · 2 generations on7descendants
- K111506Elecsys Precicontrol Varia 3Roche Diagnostics · 2011 · 3 generations on3descendants
- K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3Roche Diagnostics · 2013 · 4 generations on2descendants
- K103716Roche Elecsys Folate RBC; Roche Elecsys Folate RBC CalsetRoche Diagnostics · 2011 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K924862 | Aia-Pack HCG Calibration Verification Test Set | Tosoh Medics, Inc. | 1992 | — |
| −1 | K963147 | Elecsys Calcheck TSH | Boehringer Mannheim Corp. | 1996 | — |
| 0 (this device) | K974384 | Elecsys Calcheck Folate | Boehringer Mannheim Corp. | 1997 | — |
| +1 | K043320 | Modification to Roche Elecsys Folate II Calcheck II | Roche Diagnostics Corp. | 2004 | — |
| +2 | K082340 | Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing Reagent, Roche… | Roche Diagnostics Corp. | 2009 | — |
| +3 | K111506 | Elecsys Precicontrol Varia 3 | Roche Diagnostics | 2011 | 1 |
| +4 | K132828 | Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol… | Roche Diagnostics | 2013 | — |
| +3 | K103716 | Roche Elecsys Folate RBC; Roche Elecsys Folate RBC Calset | Roche Diagnostics | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 JJY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K963147 | Elecsys Calcheck TSHSummary page 1…nassayed) The Boehringer Mannheim Elecsys® CalCheck™ Folate is substantially equivalent to the currently marketed Elecsys® CalCheck™ TSH Calibration Verification Test (K963147). The Boehringer Mannheim Elecsys® CalCheck™ Folate is manufactured using human serum albumin, Folate, stabilizers, and preserva… | 1996 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043320 | Modification to Roche Elecsys Folate II Calcheck II | 2004 | 8 |
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 5 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K043320 (Roche Diagnostics Corp., 2004) has gone furthest, with 8 descendants of its own.
- 7 other devices also cite its predicate K963147.
How does its category compare?
All JJY devicesJJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJY
3in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJY
78in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJY
13in 2025
MAUDE reports naming product code JJY, 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 | 11 | 49 | 5 | 2 |
| 2008 | 7 | 54 | 0 | 1 |
| 2009 | 8 | 80 | 2 | 3 |
| 2010 | 10 | 109 | 6 | 3 |
| 2011 | 14 | 120 | 1 | 6 |
| 2012 | 13 | 40 | 3 | 20 |
| 2013 | 16 | 82 | 2 | 5 |
| 2014 | 10 | 49 | 2 | 4 |
| 2015 | 4 | 153 | 1 | 4 |
| 2016 | 1 | — | 3 | 13 |
| 2017 | 3 | 78 | 4 | 12 |
| 2018 | 0 | — | 3 | 7 |
| 2019 | 0 | — | 4 | 1 |
| 2020 | 0 | — | 6 | 7 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 3 | 0 |
| 2023 | 0 | — | 3 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 2 | 13 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
Elecsys CalCheck Folate calibration verification solutions comprise three levels - low, mid, and high - each with a defined Folate concentration. The low solution concentration is near the clinical deficiency range of the assay. The mid solution is in the middle point of the measuring range. The high solution is near the upper limit of the measuring range.
The Elecsys CalCheck Folate is intended for use in periodic verification of the calibration of the Elecsys Folate assay.
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/K974384 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974384: Elecsys Calcheck Folate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974384
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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