Cleared Traditional

K771947 - INSULIN RIA MODULE

K771947 is an FDA 510(k) clearance for INSULIN RIA MODULE, manufactured by Inter Science Institute. The device is a Class 1 Immunology device with product code CFP cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K771947 · Inter Science Institute · Immunology device
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Jan 1978
Decision
95d
Days
Class 1
Risk

K771947 is an FDA 510(k) clearance for the INSULIN RIA MODULE. Classified as Radioimmunoassay, Immunoreactive Insulin (product code CFP), 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 862.1405 - 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.

FDA 510(k) Submission Details - K771947

510(k) Number K771947 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
10d faster than avg
Panel avg: 105d · This submission: 95d
Pathway characteristics
Predicate-based equivalence.

CFP Device Classification - Class 1, General Controls

Product Code CFP Radioimmunoassay, Immunoreactive Insulin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1405
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.

Regulatory Peers - CFP Radioimmunoassay, Immunoreactive Insulin

All 26
Devices cleared under the same product code (CFP) and FDA review panel - the closest regulatory comparables to K771947.
RIA, INSULIN, DOUBLE ANTIBODY
K790630 · Endocrine-Metabolic Center · Jul 1979
INSULIN AUTOPAK
K781086 · Micromedic Systems · Aug 1978
INSULIN RIA KIT
K781285 · Serono Laboratories, Inc. · Aug 1978
RSL INSULIN KIT
K772281 · Radioassay Systems Laboratories, Inc. · Jan 1978
CENTRIA INSULIN RIA
K771979 · Union Carbide Corp. · Nov 1977
NSULIN RIA KIT 125I
K771628 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1977
K771947 · INSULIN RIA MODULE
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