Cleared Traditional

K922715 - IMMUCHEM PRL-MW ELISA

K922715 is an FDA 510(k) clearance for IMMUCHEM PRL-MW ELISA, manufactured by Icn Biomedicals, Inc.. The device is a Class 1 Chemistry device with product code CFT cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K922715 · Icn Biomedicals, Inc. · Chemistry device
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Oct 1992
Decision
122d
Days
Class 1
Risk

K922715 is an FDA 510(k) clearance for the IMMUCHEM PRL-MW ELISA. Classified as Radioimmunoassay, Prolactin (lactogen) (product code CFT), 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 122 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1625 - 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

FDA 510(k) Submission Details - K922715

510(k) Number K922715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1992
Decision Date October 05, 1992
Days to Decision 122 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
34d slower than avg
Panel avg: 88d · This submission: 122d
Pathway characteristics
Predicate-based equivalence.

CFT Device Classification - Class 1, General Controls

Product Code CFT Radioimmunoassay, Prolactin (lactogen)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1625
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 - CFT Radioimmunoassay, Prolactin (lactogen)

All 66
Devices cleared under the same product code (CFT) and FDA review panel - the closest regulatory comparables to K922715.
COBAS CORE PROLACTIN EIA
K930305 · Roche Diagnostic Systems, Inc. · Aug 1993
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IMMULITE PROLACTIN
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AMERLITE PROLACTIN-30 ASSAY
K922170 · Eastman Kodak Company · Sep 1992
PROLACTIN ENZYME IMMUNOASSAY TEST KIT (MODIFIED)
K920345 · Medix Biotech, Inc. · Mar 1992
AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086
K914135 · Amersham Corp. · Feb 1992