# K060585: Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol Acth

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: May 3, 2006 after 57 days
- Product code: CKG (Radioimmunoassay, Acth)
- Device class: 2
- Regulation: 21 CFR 862.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K931172 (1993). 10 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960066: Immulite Acth, Diagnostic Products Corp. (1996) Summary page 3.
- K053059: Roche Diagnostics Elecsys Prolactin II Calcheck, Roche Diagnostics (2005) Summary page 3.
- K031990: Elecsys Precicontrol Troponin T, Roche Diagnostics Corp. (2003) Summary page 3.

## Most influential descendants
- K111335: ST Aia-Pack Acth, and ST Aia-Pack Acth Calibrator Set Model 025221 and 025321 (2011), 1 descendant of its own
- K223867: Ids Acth II (2023), 0 descendants of its own
- K143296: AIA-PACK C-Peptide Control Set (2014), 0 descendants of its own
- K131662: Immulite 2000 Acth Calibration Verification Material (2013), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K060585
Methodology: https://510kreport.com/methodology