510(k) · Cleared
ClearedRoche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol Acth
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · CKG Radioimmunoassay, Acth
Cleared on May 3, 2006 as substantially equivalent to K960066 (Diagnostic Products Corp., 1996) and 2 other predicates after a 57-day review. Its family tree reaches back 5 generations to 1993. 4 later devices descend from it.
- Decided
- May 3, 2006
- Review
- 57 days
- Class
- Class II
- Product code
- CKG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K931172 (1993). 10 ancestors in all, the oldest K924863 (1992). 4 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK931172 Imx (R) Stat CK-MBAbbott Laboratories · 1993
- 4 generations backK961501 Elecsys CK-MBBoehringer Mannheim Corp. · 1996
- 3 generations backK962575 Elecsys Precicontrol CardiacBoehringer Mannheim Corp. · 1996
- 2 generations backK983492 Boehringer Mannheim Elecsys Presicontrol CardiacBoehringer Mannheim Corp. · 1998
- 1 generation backK031990 Elecsys Precicontrol Troponin TRoche Diagnostics Corp. · 2003
- This deviceK060585 Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol ActhRoche Diagnostics Corp. · 2006
- Descendant · cites it directly · 1 of its ownK111335 ST Aia-Pack Acth, and ST Aia-Pack Acth Calibrator Set Model 025221…Tosoh Bioscience, Inc. · 2011 · Recalled
- Descendant · cites it directly · 0 of its ownK223867 Ids Acth IIImmunodiagnostic Systems Limited · 2023
- Descendant · 2 generations on · 0 of its ownK143296 AIA-PACK C-Peptide Control SetTosoh Bioscience, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK131662 Immulite 2000 Acth Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc. · 2013
Most influential descendants
Showing 4 of 4 · See all- K111335ST Aia-Pack Acth, and ST Aia-Pack Acth Calibrator Set Model 025221 and 025321Tosoh Bioscience, Inc. · 2011 · cites it directly1descendant
- K223867Ids Acth IIImmunodiagnostic Systems Limited · 2023 · cites it directly0descendants
- K143296AIA-PACK C-Peptide Control SetTosoh Bioscience, Inc. · 2014 · 2 generations on0descendants
- K131662Immulite 2000 Acth Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K931172 | Imx (R) Stat CK-MB | Abbott Laboratories | 1993 | — |
| −4 | K961501 | Elecsys CK-MB | Boehringer Mannheim Corp. | 1996 | — |
| −3 | K962575 | Elecsys Precicontrol Cardiac | Boehringer Mannheim Corp. | 1996 | — |
| −2 | K983492 | Boehringer Mannheim Elecsys Presicontrol Cardiac | Boehringer Mannheim Corp. | 1998 | — |
| −1 | K031990 | Elecsys Precicontrol Troponin T | Roche Diagnostics Corp. | 2003 | — |
| 0 (this device) | K060585 | Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol Acth | Roche Diagnostics Corp. | 2006 | — |
| +1 | K111335 | ST Aia-Pack Acth, and ST Aia-Pack Acth Calibrator Set Model 025221 and 025321 | Tosoh Bioscience, Inc. | 2011 | 2 |
| +1 | K223867 | Ids Acth II | Immunodiagnostic Systems Limited | 2023 | — |
| +2 | K143296 | AIA-PACK C-Peptide Control Set | Tosoh Bioscience, Inc. | 2014 | — |
| +1 | K131662 | Immulite 2000 Acth Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2023 | 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 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? (3)
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 |
|---|---|---|---|
| * | K960066 | Immulite ActhSummary page 3…ices equivalence legally marketed in the United States. (1) Elecsys ACTH Immunoassay is equivalent to the Immulite ACTH assay (K960066). Both products are intended for use in the quantitative determination of ACTH in plasma. (2… | 1996 |
| * | K053059 | Roche Diagnostics Elecsys Prolactin II CalcheckSummary page 3…o the Immulite ACTH assay (K960066). (3) Elecsys ACTH CalCheck is equivalent to the Elecsys Prolactin II CalCheck (K053059). (4) Elecsys PreciControl ACTH is equivalent to the Elecsys PreciControl Troponin T (K03199… | 2005 |
| * | K031990 | Elecsys Precicontrol Troponin TSummary page 3…olactin II CalCheck (K053059). (4) Elecsys PreciControl ACTH is equivalent to the Elecsys PreciControl Troponin T (K031990). Continuedon next page… | 2003 |
What descends from it? (4)
3 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?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K111335 (Tosoh Bioscience, Inc., 2011) has gone furthest, with 1 descendant 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 | — |
What is it indicated for?
Elecsys ACTH Assay: Immunoasssay for the in vitro quantitative determination of adrenocorticotropic hormone (ACTH) in human EDTA plasma. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E 170 (Elecsys module) immunoassay analyzers. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushings syndrome…
Read the full statement (128 words)
Elecsys ACTH Assay:
Immunoasssay for the in vitro quantitative determination of adrenocorticotropic hormone (ACTH) in human EDTA plasma. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E 170 (Elecsys module) immunoassay analyzers. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushings syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.
Elecsys ACTH CalSet is used for calibrating the quantitative Elecsys ACTH assay on the Eleesys immunoassay analyzers.
Elecsys ACTH CalCheck:
For use in the verification of the calibration established by the Eleesys ACTH reagent on Eleesys 1010/2010 and MODULAR E170 immunoassay analyzers.
Elecsys PreciControl ACTH is used for quality control of the Elecsys ACTH immunoassay on the Elecsys immunoassay analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060585 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060585: Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol Acth.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060585
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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