510(k) · Cleared
ClearedElecsys HCG+B Calcheck
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Feb 14, 2001 after a 20-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 26 later devices descend from it.
- Decided
- Feb 14, 2001
- Review
- 20 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 0
26 later devices descend from it, 1 citing it directly.
- This deviceK010237 Elecsys HCG+B CalcheckRoche Diagnostics Corp. · 2001
- Descendant · cites it directly · 25 of its ownK092168 Elecsys HCG+B Calcheck 5Roche Diagnostics · 2009
- Descendant · 2 generations on · 16 of its ownK101075 Elecsys Insulin Calcheck 5Roche Diagnostics Corp. · 2010
- Descendant · 2 generations on · 13 of its ownK133128 Immulite 2000; HCG Calibration Verification Material, Insulin…Siemens Healthcare Diagnostics, Inc. · 2013
- Descendant · 3 generations on · 7 of its ownK140258 Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH…Siemens Healthcare Diagnostics, Inc. · 2014
- Descendant · 3 generations on · 3 of its ownK140818 Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I…Siemens Healthcare Diagnostics, Inc. · 2014
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K092168Elecsys HCG+B Calcheck 5Roche Diagnostics · 2009 · cites it directly25descendants
- K101075Elecsys Insulin Calcheck 5Roche Diagnostics Corp. · 2010 · 2 generations on16descendants
- K133128Immulite 2000; HCG Calibration Verification Material, Insulin Calibration Verification…Siemens Healthcare Diagnostics, Inc. · 2013 · 2 generations on13descendants
- K140258Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH Calibration Verification…Siemens Healthcare Diagnostics, Inc. · 2014 · 3 generations on7descendants
- K140818Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I Calibration…Siemens Healthcare Diagnostics, Inc. · 2014 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010237 | Elecsys HCG+B Calcheck | Roche Diagnostics Corp. | 2001 | — |
| +1 | K092168 | Elecsys HCG+B Calcheck 5 | Roche Diagnostics | 2009 | — |
| +2 | K101075 | Elecsys Insulin Calcheck 5 | Roche Diagnostics Corp. | 2010 | — |
| +2 | K133128 | Immulite 2000; HCG Calibration Verification Material, Insulin Calibration… | Siemens Healthcare Diagnostics, Inc. | 2013 | — |
| +3 | K140258 | Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH Calibration… | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
| +3 | K140818 | Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I… | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 11 | 0 |
| 2015 | 5 | 0 |
| 2016 | 2 | 0 |
| 2019 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (26)
See all 261 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092168 | Elecsys HCG+B Calcheck 5 | 2009 | 25 |
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?
- Of its descendants, K092168 (Roche Diagnostics, 2009) has gone furthest, with 25 descendants of its own.
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 | — |
https://510kreport.com/device/K010237 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010237: Elecsys HCG+B Calcheck.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010237
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026