510(k) · Cleared
ClearedElecsys Calcheck Testosterone
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 Jan 30, 1997 as substantially equivalent to K924863 (Tosoh Medics, Inc., 1992) after a 15-day review. Its family tree reaches back 1 generation to 1992. 4 later devices descend from it.
- Decided
- Jan 30, 1997
- Review
- 15 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K924863 (1992). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK924863 Aia-Pack FSH Calibration Verification Test SetTosoh Medics, Inc. · 1992
- This deviceK970146 Elecsys Calcheck TestosteroneBoehringer Mannheim Corp. · 1997
- Descendant · cites it directly · 3 of its ownK140505 Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master…Siemens Healthcare Diagnostics, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK151986 ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II…Siemens Healthcare Diagnostics, Inc. · 2016
- Descendant · 3 generations on · 0 of its ownK191533 ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBGSiemens Healthcare Diagnostics, Inc. · 2019
- Descendant · 3 generations on · 0 of its ownK190121 Ids SHBGImmunodiagnostic Systems, Ltd. · 2019
Most influential descendants
Showing 4 of 4 · See all- K140505Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master Curve Material, and…Siemens Healthcare Diagnostics, Inc. · 2014 · cites it directly3descendants
- K151986ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve…Siemens Healthcare Diagnostics, Inc. · 2016 · 2 generations on2descendants
- K191533ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBGSiemens Healthcare Diagnostics, Inc. · 2019 · 3 generations on0descendants
- K190121Ids SHBGImmunodiagnostic Systems, Ltd. · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924863 | Aia-Pack FSH Calibration Verification Test Set | Tosoh Medics, Inc. | 1992 | — |
| 0 (this device) | K970146 | Elecsys Calcheck Testosterone | Boehringer Mannheim Corp. | 1997 | — |
| +1 | K140505 | Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master Curve… | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
| +2 | K151986 | ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII)… | Siemens Healthcare Diagnostics, Inc. | 2016 | — |
| +3 | K191533 | ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG | Siemens Healthcare Diagnostics, Inc. | 2019 | — |
| +3 | K190121 | Ids SHBG | Immunodiagnostic Systems, Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 2 | 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 |
|---|---|---|---|
| * | K924863 | Aia-Pack FSH Calibration Verification Test SetSummary page 1…r Mannheim Elecsys CalCheck Testosterone is substantially Predicate equivalent to the currently marketed Tosoh Medics AIA-Pack FSH device Calibration Verification Test. (K924863) 4. The Boehringer Mannheim Elecsys CalCheck Testosterone is manufactured D"'c? ) using human serum albumin, testosterone, stabil… | 1992 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140505 | Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master Curve Material, and… | 2014 | 3 |
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?
The Boehringer Mannheim Elecsys CalCheck Testosterone is used to verify the calibration assignment for the Boehringer Mannheim Elecsys Testosterone 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/K970146 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970146: Elecsys Calcheck Testosterone.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970146
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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