Cleared Traditional

K922944 - IMMUCHEM LH-MW ELISA

K922944 is an FDA 510(k) clearance for IMMUCHEM LH-MW ELISA, manufactured by Icn Biomedicals, Inc.. The device is a Class 1 Chemistry device with product code CEP cleared through the Traditional 510(k) pathway after a 229-day FDA review.

K922944 · Icn Biomedicals, Inc. · Chemistry device
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Feb 1993
Decision
229d
Days
Class 1
Risk

K922944 is an FDA 510(k) clearance for the IMMUCHEM LH-MW ELISA. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Icn Biomedicals, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on February 2, 1993 after a review of 229 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1485 - 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 - K922944

510(k) Number K922944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1992
Decision Date February 02, 1993
Days to Decision 229 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
141d slower than avg
Panel avg: 88d · This submission: 229d
Pathway characteristics
Predicate-based equivalence.

CEP Device Classification - Class 1, General Controls

Product Code CEP Radioimmunoassay, Luteinizing Hormone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1485
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 - CEP Radioimmunoassay, Luteinizing Hormone

All 102
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K922944.
ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY
K940549 · Bio-Rad Laboratories, Inc. · Apr 1994
VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY
K926394 · Syva Co. · May 1993
COBAS CORE LH EIA
K930306 · Roche Diagnostic Systems, Inc. · May 1993
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
K921176 · Vitek Systems, Inc. · Apr 1992
LH GEN III SELF-TEST/CONCEIVE
K920160 · Quidel Corp. · Mar 1992
MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT
K920504 · Medix Biotech, Inc. · Mar 1992