510(k) · Cleared
ClearedElecsys Anti-TSHR Calcheck
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Aug 22, 2008 as substantially equivalent to K040157 (Roche Diagnostics Corp., 2004) after a 169-day review. Its family tree reaches back 4 generations to 2000. 1 later device descends from it.
- Decided
- Aug 22, 2008
- Review
- 169 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K001015 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK001015 Elecsys Thyroglobulin CalcheckRoche Diagnostics Corp. · 2000
- 3 generations backK020883 Elecsys Probnp CalcheckRoche Diagnostics Corp. · 2002
- 2 generations backK031698 Elecys SHBG CalcheckRoche Diagnostics Corp. · 2003
- 1 generation backK040157 Elecsys C-Peptide CalcheckRoche Diagnostics Corp. · 2004
- This deviceK080643 Elecsys Anti-TSHR CalcheckRoche Diagnostics · 2008
- Descendant · cites it directly · 0 of its ownK152061 IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification…Siemens Healthcare Diagnostics, Inc. · 2016 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K152061IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001015 | Elecsys Thyroglobulin Calcheck | Roche Diagnostics Corp. | 2000 | — |
| −3 | K020883 | Elecsys Probnp Calcheck | Roche Diagnostics Corp. | 2002 | — |
| −2 | K031698 | Elecys SHBG Calcheck | Roche Diagnostics Corp. | 2003 | — |
| −1 | K040157 | Elecsys C-Peptide Calcheck | Roche Diagnostics Corp. | 2004 | — |
| 0 (this device) | K080643 | Elecsys Anti-TSHR Calcheck | Roche Diagnostics | 2008 | — |
| +1 | K152061 | IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | 2016 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 |
|---|---|---|---|
| * | K040157 | Elecsys C-Peptide CalcheckSummary page 1…oducts in commercial distribution intended for simrilar use. We claim equivalency to the currently marketed Eleesys (>Peptide CalCheck (K0401 57). IDevice T he Eleesys Anti-TSI IR CalCheck is a Iyophilized product consisting ol Description human anti-TSHR an… | 2004 |
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 |
|---|---|---|---|
| K152061 | IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material | 2016 | 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 8 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K152061 (Siemens Healthcare Diagnostics, Inc., 2016) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K040157.
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. 2008, this device’s year, is highlighted.
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?
For use in the verification of the calibration established by the Elecsys Anti-TSHR reagent on the indicated Elecsys and cobas e immunoassay analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080643 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080643: Elecsys Anti-TSHR Calcheck.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080643
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