# K021032: Acth Immunoradiometric (Irma) Diagnostic Assay Kit, Model #3KG100

- Pathway: 510(k) (Traditional)
- Applicant: Scantibodies Laboratory, Inc.
- Decided: Jun 3, 2002 after 66 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/K021032
Methodology: https://510kreport.com/methodology