# K050748: Acth Immunoradiometric (Irma) Assay Kit, Model 3KG011

- Pathway: 510(k) (Traditional)
- Applicant: Scantibodies Laboratory, Inc.
- Decided: May 20, 2005 after 59 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Scantibodies Laboratory, Inc. Adrenocorticotropic Hormone (ACTH) test system is a device intended to measure adrenocorticotropic hormone in plasma. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands, such as Cushing's syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.

Source page: https://510kreport.com/device/K050748
Methodology: https://510kreport.com/methodology