510(k) · Cleared
ClearedElecsys Calcheck TSH
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Aug 23, 1996 as substantially equivalent to K924862 (Tosoh Medics, Inc., 1992) after a 10-day review. Its family tree reaches back 1 generation to 1992. 32 later devices descend from it.
- Decided
- Aug 23, 1996
- Review
- 10 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K924862 (1992). 32 later devices descend from it, 8 citing it directly.
- Root · 1 generation backK924862 Aia-Pack HCG Calibration Verification Test SetTosoh Medics, Inc. · 1992
- This deviceK963147 Elecsys Calcheck TSHBoehringer Mannheim Corp. · 1996
- Descendant · cites it directly · 10 of its ownK974383 Elecsys Calcheck Vitamin B12Boehringer Mannheim Corp. · 1997
- Descendant · 2 generations on · 9 of its ownK060755 Elecsys Vitamin B12 Immunoassay, Calset II and CalcheckRoche Diagnostics Corp. · 2006
- Descendant · cites it directly · 9 of its ownK974384 Elecsys Calcheck FolateBoehringer Mannheim Corp. · 1997
- Descendant · 2 generations on · 8 of its ownK043320 Modification to Roche Elecsys Folate II Calcheck IIRoche Diagnostics Corp. · 2004
- Descendant · 3 generations on · 7 of its ownK082340 Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing…Roche Diagnostics Corp. · 2009
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K974383Elecsys Calcheck Vitamin B12Boehringer Mannheim Corp. · 1997 · cites it directly10descendants
- K060755Elecsys Vitamin B12 Immunoassay, Calset II and CalcheckRoche Diagnostics Corp. · 2006 · 2 generations on9descendants
- K974384Elecsys Calcheck FolateBoehringer Mannheim Corp. · 1997 · cites it directly9descendants
- K043320Modification to Roche Elecsys Folate II Calcheck IIRoche 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924862 | Aia-Pack HCG Calibration Verification Test Set | Tosoh Medics, Inc. | 1992 | — |
| 0 (this device) | K963147 | Elecsys Calcheck TSH | Boehringer Mannheim Corp. | 1996 | — |
| +1 | K974383 | Elecsys Calcheck Vitamin B12 | Boehringer Mannheim Corp. | 1997 | — |
| +2 | K060755 | Elecsys Vitamin B12 Immunoassay, Calset II and Calcheck | Roche Diagnostics Corp. | 2006 | — |
| +1 | K974384 | Elecsys Calcheck Folate | Boehringer Mannheim Corp. | 1997 | — |
| +2 | K043320 | Modification to Roche Elecsys Folate II Calcheck II | Roche Diagnostics Corp. | 2004 | — |
| +3 | K082340 | Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing Reagent, Roche… | Roche Diagnostics Corp. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 6 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 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 JJX? 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 |
|---|---|---|---|
| * | K924862 | Aia-Pack HCG Calibration Verification Test SetSummary page 1…tion name: Single (specified) analyte controls (assayed + unassayed) We claim substantial equivalence to the Tosoh Medic AIA-Pack HCG Calibration Verification Test Set, K924862. The intended use for both products is to verify the calibration curve of automated immunoassay analyzers The Elecsys CalCheck T… | 1992 |
What descends from it? (32)
See all 328 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K974383 | Elecsys Calcheck Vitamin B12 | 1997 | 10 |
| K974384 | Elecsys Calcheck Folate | 1997 | 9 |
| K973973 | Elecsys Callcheck Digoxin | 1997 | 3 |
| K020369 | Elecsys Anti-TG Calcheck | 2002 | 1 |
| K970452 | Elecsys Calcheck Cea | 1997 | 1 |
| K093836 | Elecsys TSH Calcheck 5 | 2010 | 0 |
| K970458 | Elecsys Calcheck Psa | 1997 | 0 |
| K970459 | Elecsys Calcheck Cea | 1997 | 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?
How does its category compare?
All JJX devicesJJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJX
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJX
31in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJX
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJX
22in 2025
MAUDE reports naming product code JJX, 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 | 6 | 53 | 3 | 2 |
| 2008 | 8 | 52 | 3 | 0 |
| 2009 | 17 | 80 | 0 | 1 |
| 2010 | 24 | 80 | 3 | 6 |
| 2011 | 19 | 62 | 2 | 62 |
| 2012 | 15 | 40 | 0 | 32 |
| 2013 | 19 | 37 | 0 | 51 |
| 2014 | 22 | 30 | 1 | 48 |
| 2015 | 11 | 65 | 1 | 67 |
| 2016 | 6 | 31 | 2 | 37 |
| 2017 | 2 | — | 0 | 19 |
| 2018 | 0 | — | 2 | 35 |
| 2019 | 0 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 77 |
| 2021 | 0 | — | 1 | 43 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Elecsys CalCheck TSH is intended for use in the quantitative verification of the calibration curve established by the Elecsys TSH reagents and calibrators on Elecsys 1010 or 2010 immunoassay 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/K963147 · printed Nov 3, 2026
Cite this page
510(k) Report. “K963147: Elecsys Calcheck TSH.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K963147
Report an extraction error
Are you the manufacturer?
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