GASTRIN EIA MODEL 06B-555017

K961276 · Biosyn , Ltd. · CGC · May 30, 1996 · Clinical Chemistry

Device Facts

• Record ID: K961276
• Device Name: GASTRIN EIA MODEL 06B-555017
• Applicant: Biosyn , Ltd.
• Product Code: CGC · Clinical Chemistry
• Decision Date: May 30, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1325
• Device Class: Class 1

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, achlorhydria (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 H₂ 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.

Device Story

In vitro enzyme immunoassay (EIA) for quantitative measurement of gastrin in human serum; utilizes competition reaction between serum gastrin and immobilized gastrin for anti-gastrin antibody binding; antibody binding inversely proportional to gastrin concentration; utilizes antibody-enzyme conjugate and chromogenic substrate for detection; replaces radioactive tracers used in traditional radioimmunoassays (RIA); performed in clinical laboratory settings; results used by physicians to diagnose gastric conditions and monitor therapeutic efficacy of antisecretory drugs; provides non-hazardous alternative to RIA with expanded standard curve for high-concentration samples.

Clinical Evidence

Clinical performance evaluated by comparing patient sample results from Gastrin EIA against predicate RIA using linear regression analysis. Results demonstrated no statistical difference between the two methods.

Technological Characteristics

In vitro enzyme immunoassay; competition reaction principle; multi-specific antiserum; antibody-enzyme conjugate and chromogenic substrate detection; non-radioactive; expanded standard curve compared to RIA; no extracted human components in standards.

Indications for Use

Indicated for quantitative measurement of gastrin in human serum to aid in diagnosis of Zollinger-Ellison Syndrome, gastric cancers, achlorhydria, G-cell hyperplasia, and duodenal ulcer; also used to monitor patients post-gastric surgery or undergoing treatment with histamine H2 receptor antagonists/antisecretory drugs.

Regulatory Classification

Identification

A gastrin test system is a device intended to measure the hormone gastrin in plasma and serum. Measurements of gastrin are used in the diagnosis and treatment of patients with ulcers, pernicious anemia, and the Zollinger-Ellison syndrome (peptic ulcer due to a gastrin-secreting tumor of the pancreas).

Predicate Devices

• Gastrin (l¹²⁵) Radioimmunoassay Kit (K821175)

Submission Summary (Full Text)

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2. 510(k) SUMMARY

K961276

MAY 30 1996

# 510(k) SUMMARY

[as required by Section 807.92 (c)]

Submitter's Name: Biosyn Ltd

Address: 10 Malone Road
Belfast
BT9 5BN
N. Ireland.

Phone: [phone]

Fax: [phone]

Contact Person: Jennifer McKay

Title: Technical Manager

Date: 29th March 1996.

## PRODUCT INFORMATION

Common/usual or classification name: Gastrin Enzyme Immunoassay Kit

Trade or proprietary name: Gastrin EIA

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K961276

5

Device to which Substantial Equivalence is claimed:
Gastrin (l¹²⁵) Radioimmunoassay Kit.
K821175

## Description of Gastrin EIA:

Gastrin EIA is an in vitro enzyme immunoassay for the quantitative measurement of gastrin in human serum. Gastrin in serum is assayed by a competition reaction using an antibody raised against a gastrin immunogen. Gastrin in standards and samples compete with immobilised Gastrin in binding the anti-gastrin antibody. The extent of antibody binding to the solid phase is inversely related to the concentration of Gastrin in the standard or patient sample.

## Intended 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, achlorhydria (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 H₂ 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.

## Comparison of Technological Characteristics of EIA and RIA:

Both are designed to quantify gastrin in a patient’s serum sample by means of a competition reaction. Both use a multi-specific antiserum generated against a gastrin immunogen.

The RIA utilizes a radioactive tracer as its means of detection while the EIA uses an antibody-enzyme conjugate and chromogenic substrate both of which are non-hazardous and non-carcinogenic.

The EIA expands on the RIA standard curve facilitating easier measurement of very high patient samples. Unlike the RIA, the EIA does not use any extracted human components in its standards.

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The EIA kit size and smaller RIA kit size are similar, but the EIA can be used for up to 4 separate assays.

## Assessment of Clinical Performance Data:

Patient samples were analysed by both EIA and RIA and results subjected to a linear regression analysis. Results obtained showed that their was no statistical difference between the two tests.

## Conclusions:

Comparison of the technological characteristics of the EIA and RIA in conjunction with the Clinical performance data show that the Gastrin EIA is substantially equivalent to the RIA K821175.