510(k) · Cleared
ClearedImmulite Acth
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Products Corp. · CKG Radioimmunoassay, Acth
Cleared on Feb 16, 1996 after a 42-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Feb 16, 1996
- Review
- 42 days
- Class
- Class II
- Product code
- CKG
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK960066 Immulite ActhDiagnostic Products Corp. · 1996
- Descendant · cites it directly · 4 of its ownK060585 Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol ActhRoche Diagnostics Corp. · 2006
- Descendant · 2 generations on · 1 of its ownK111335 ST Aia-Pack Acth, and ST Aia-Pack Acth Calibrator Set Model 025221…Tosoh Bioscience, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 0 of its ownK223867 Ids Acth IIImmunodiagnostic Systems Limited · 2023
- Descendant · 3 generations on · 0 of its ownK143296 AIA-PACK C-Peptide Control SetTosoh Bioscience, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK131662 Immulite 2000 Acth Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc. · 2013
Most influential descendants
Showing 5 of 5 · See all- K060585Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol ActhRoche Diagnostics Corp. · 2006 · cites it directly4descendants
- K111335ST Aia-Pack Acth, and ST Aia-Pack Acth Calibrator Set Model 025221 and 025321Tosoh Bioscience, Inc. · 2011 · 2 generations on1descendant
- K223867Ids Acth IIImmunodiagnostic Systems Limited · 2023 · 2 generations on0descendants
- K143296AIA-PACK C-Peptide Control SetTosoh Bioscience, Inc. · 2014 · 3 generations on0descendants
- K131662Immulite 2000 Acth Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960066 | Immulite Acth | Diagnostic Products Corp. | 1996 | — |
| +1 | K060585 | Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol Acth | Roche Diagnostics Corp. | 2006 | — |
| +2 | K111335 | ST Aia-Pack Acth, and ST Aia-Pack Acth Calibrator Set Model 025221 and 025321 | Tosoh Bioscience, Inc. | 2011 | 2 |
| +2 | K223867 | Ids Acth II | Immunodiagnostic Systems Limited | 2023 | — |
| +3 | K143296 | AIA-PACK C-Peptide Control Set | Tosoh Bioscience, Inc. | 2014 | — |
| +2 | K131662 | Immulite 2000 Acth Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 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 CKG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CKG device
- #1 K223867 Ids Acth IIscore 7.4 · 6 generations · no Class I recall
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? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060585 | Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol Acth | 2006 | 4 |
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, K060585 (Roche Diagnostics Corp., 2006) has gone furthest, with 4 descendants of its own.
How does its category compare?
All CKG devicesCKG Radioimmunoassay, Acth: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CKG
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · CKG
Too few CKG 510(k)s in any year since 2007 to give a median.
Recalls per year · CKG
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CKG
4in 2025
MAUDE reports naming product code CKG, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 1 | 2 |
| 2019 | 0 | — | 0 | 8 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 3 | 4 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K960066 · printed Nov 5, 2026
Cite this page
510(k) Report. “K960066: Immulite Acth.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K960066
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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