# K982491: Sangui Biotech, Inc. Calcitonin Elisa Kit

- Pathway: 510(k) (Traditional)
- Applicant: Sangui Biotech, Inc.
- Decided: Sep 3, 1998 after 48 days
- Product code: JKR (Radioimmunoassay, Calcitonin)
- Device class: 2
- Regulation: 21 CFR 862.1140
- Recalls of this device: 1 (0 Class I)
- 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) Scantibodies Calcitonin Assay Immunoradiometric (IRMA) Assay (Coated Bead Technology), Part Number 3KG552: named in the summary without a submission number
- (no number) Nichols Institute Diagnostics Calcitonin Chemiluminescence Assay: named in the summary without a submission number

## Recalls of this device
- Sep 18, 2014 · Class II · Z-0467-2015: A potential issue with false high values.

## Indications for use
The intended use of this product is the quantitative determination of Calcitonin in human serum. This immunocassay is based on the principles of the two site “sandwich” Enzyme-Linked ImmunoSorbent Assay (ELISA). Calcitonin measurements are used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism (excessive activity of the parathyroid gland).

Source page: https://510kreport.com/device/K982491
Methodology: https://510kreport.com/methodology