Cleared Traditional

IMMUCHEM PRL-MW ELISA (K922715) - FDA 510(k) Clearance

Class I Chemistry device.

K922715 · Icn Biomedicals, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 79
Devices cleared under the same product code (CFT) and FDA review panel - the closest regulatory comparables to K922715.
ELECSYS PROLACTIN ASSAY
K964748 · Boehringer Mannheim Corp. · Jan 1997
AXSYM PROLACTIN
K935675 · Abbott Laboratories · Jun 1994
COBAS CORE PROLACTIN EIA
K930305 · Roche Diagnostic Systems, Inc. · Aug 1993
VISTA PROLACTIN ASSAY
K926386 · Syva Co. · Mar 1993
IMMULITE PROLACTIN
K925846 · Diagnostic Products Corp. · Mar 1993
AMERLITE PROLACTIN-30 ASSAY
K922170 · Eastman Kodak Company · Sep 1992