Cleared Traditional

GASTRIN RIA MODULE (K771953) - FDA 510(k) Clearance

Class I Immunology device.

K771953 · Inter Science Institute · Immunology device
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Jan 1978
Decision
95d
Days
Class 1
Risk

K771953 is an FDA 510(k) clearance for the GASTRIN RIA MODULE. Classified as Radioimmunoassay, Gastrin (product code CGC), Class I - General Controls.

Submitted by Inter Science Institute (Mchenry, US). The FDA issued a Cleared decision on January 20, 1978 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1325 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K771953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1977
Decision Date January 20, 1978
Days to Decision 95 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 104d · This submission: 95d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CGC Radioimmunoassay, Gastrin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1325
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.