# K223867: Ids Acth II

- Pathway: 510(k) (Traditional)
- Applicant: Immunodiagnostic Systems Limited
- Decided: Aug 18, 2023 after 238 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: 6 generations back to K931172 (1993). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060585: Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol Acth, Roche Diagnostics Corp. (2006) Summary page 5.

## Indications for use
IDS ACTH II assay is an automated in vitro diagnostic device intended for the quantitative, determination of ACTH in human K2 and K3 EDTA plasma on the IDS system. Results are to be used in conjunction with other clinical and laboratory data as an aid in the assessment of pituitary and adrenal gland function and the differential diagnosis of hyper- and hypo-cortisolism.

Source page: https://510kreport.com/device/K223867
Methodology: https://510kreport.com/methodology