Cleared Traditional

INSULIN RIA MODULE (K771947) - FDA 510(k) Clearance

Class I Immunology device.

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.

View all Inter Science Institute devices

Submission Details

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
9d faster than avg
Panel avg: 104d · This submission: 95d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.
IMX INSULIN
K920109 · Abbott Laboratories · May 1992
ENZYMUN TEST(R) INSULIN
K901135 · Boehringer Mannheim Corp. · Apr 1990
REP(TM) SPE PLUS-30 PROCEDURES
K896572 · Helena Laboratories · Jan 1990
COAT-A-COUNT INSULIN KIT
K821861 · Diagnostic Products Corp. · Jul 1982
ARIA II INSULIN RIA
K811144 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1981
NSULIN RIA KIT 125I
K771628 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1977