# K982608: Sangui Biotech, Inc. Acth (Adrenocorticotropic Hormone) Elisa Kit

- Pathway: 510(k) (Traditional)
- Applicant: Sangui Biotech, Inc.
- Decided: Aug 19, 1998 after 23 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. The FDA summary names its predicate without a number.
- (no number) Nichols Institute Diagnostics ACTH [Adrenocorticotropic Hormone] Radioisotopic Assay: named in the summary without a submission number

## Indications for use
The intended use of this product is the quantitative determination of ACTH [Adrenocorticotropic Hormone] in human EDTA plasma. This immunoassay is based on the principles of the two site “sandwich” Enzyme-Linked ImmunoSorbent Assay (ELISA).

Source page: https://510kreport.com/device/K982608
Methodology: https://510kreport.com/methodology