Cleared Traditional

ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT (K922376) - FDA 510(k) Clearance

Class I Chemistry device.

K922376 · Icn Biomedicals, Inc. · Chemistry device
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Oct 1992
Decision
138d
Days
Class 1
Risk

K922376 is an FDA 510(k) clearance for the ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT. Classified as Radioimmunoassay, Follicle-stimulating Hormone (product code CGJ), Class I - General Controls.

Submitted by Icn Biomedicals, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on October 5, 1992 after a review of 138 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1300 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Icn Biomedicals, Inc. devices

Submission Details

510(k) Number K922376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1992
Decision Date October 05, 1992
Days to Decision 138 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 88d · This submission: 138d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CGJ Radioimmunoassay, Follicle-stimulating Hormone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1300
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 - CGJ Radioimmunoassay, Follicle-stimulating Hormone

All 87
Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K922376.
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AFFINITY FSH TEST SYSTEM
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ENZYMUN TEST(R) FSH
K900763 · Boehringer Mannheim Corp. · Mar 1990
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K895005 · Diagnostic Products Corp. · Oct 1989