# K961276: Gastrin Eia Model 06B-555017

- Pathway: 510(k) (Traditional)
- Applicant: Biosyn, Ltd.
- Decided: May 30, 1996 after 57 days
- Product code: CGC (Radioimmunoassay, Gastrin)
- Device class: 1
- Regulation: 21 CFR 862.1325
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K821175 (1982). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K821175: Gastrin Radioimmunoassay Kit (125-I), Bd Becton Dickinson Vacutainer Systems Preanalytic (1982) Summary page 2.

## Indications for use
The intended use of the Gastrin EIA is for quantitative measurement of Gastrin in human serum. Gastrin is a polypeptide hormone produced and secreted by the G cells of the gastric antral mucosa. It occurs in the circulation in several different forms, among those Gastrin-17 and Gastrin-34, sulphated and non-sulphated. The determination of serum gastrin can be used as an aid in the diagnosis of Zollinger-Ellison Syndrome, gastric cancers, achlorhydia ( with or without pernicious anaemia), G-cell hyperplasia and duodenal ulcer. In all of these clinical conditions the serum gastrin concentration is elevated. Normal fasting serum gastrin concentrations are below 100 pg/ml, while fasting serum levels in the above conditions are significantly higher. Measurement of serum gastrin may also be used to monitor patients with previous gastric surgery. Treatment with histamine H, receptor antagonists and with antisecretory drugs may cause a rise in the serum gastrin concentration. Quantification of serum gastrin can then be used to monitor treatment with these drugs.

Source page: https://510kreport.com/device/K961276
Methodology: https://510kreport.com/methodology