510(k) · Cleared
ClearedAia-Pack FSH Calibration Verification Test Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tosoh Medics, Inc. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Nov 16, 1992 after a 49-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 15 later devices descend from it.
- Decided
- Nov 16, 1992
- Review
- 49 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 5 citing it directly.
- This deviceK924863 Aia-Pack FSH Calibration Verification Test SetTosoh Medics, Inc. · 1992
- Descendant · cites it directly · 6 of its ownK970147 Elecsys Calcheck ProlactinBoehringer Mannheim Corp. · 1997
- Descendant · 2 generations on · 5 of its ownK053059 Roche Diagnostics Elecsys Prolactin II CalcheckRoche Diagnostics · 2005
- Descendant · 3 generations on · 4 of its ownK060585 Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol ActhRoche Diagnostics Corp. · 2006
- Descendant · cites it directly · 4 of its ownK970146 Elecsys Calcheck TestosteroneBoehringer Mannheim Corp. · 1997
- Descendant · 2 generations on · 3 of its ownK140505 Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master…Siemens Healthcare Diagnostics, Inc. · 2014
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K970147Elecsys Calcheck ProlactinBoehringer Mannheim Corp. · 1997 · cites it directly6descendants
- K053059Roche Diagnostics Elecsys Prolactin II CalcheckRoche Diagnostics · 2005 · 2 generations on5descendants
- K060585Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol ActhRoche Diagnostics Corp. · 2006 · 3 generations on4descendants
- K970146Elecsys Calcheck TestosteroneBoehringer Mannheim Corp. · 1997 · cites it directly4descendants
- K140505Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master Curve Material, and…Siemens Healthcare Diagnostics, Inc. · 2014 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K924863 | Aia-Pack FSH Calibration Verification Test Set | Tosoh Medics, Inc. | 1992 | — |
| +1 | K970147 | Elecsys Calcheck Prolactin | Boehringer Mannheim Corp. | 1997 | — |
| +2 | K053059 | Roche Diagnostics Elecsys Prolactin II Calcheck | Roche Diagnostics | 2005 | — |
| +3 | K060585 | Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol Acth | Roche Diagnostics Corp. | 2006 | — |
| +1 | K970146 | Elecsys Calcheck Testosterone | Boehringer Mannheim Corp. | 1997 | — |
| +2 | K140505 | Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master Curve… | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2019 | 2 | 0 |
| 2023 | 1 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (15)
See all 155 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K970147 (Boehringer Mannheim Corp., 1997) has gone furthest, with 6 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/K924863 · printed Nov 6, 2026
Cite this page
510(k) Report. “K924863: Aia-Pack FSH Calibration Verification Test Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924863
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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