Cleared Traditional

K922047 - IGE ENZYME IMMUNOASSAY TEST KIT CAT.NO....

K922047 is the FDA 510(k) clearance for IGE ENZYME IMMUNOASSAY TEST KIT CAT.NO.... by Medix Biotech, Inc.. It is a Class 2 Immunology device (product code DGC) cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K922047 · Medix Biotech, Inc. · Immunology device
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Aug 1992
Decision
96d
Days
Class 2
Risk

K922047 is an FDA 510(k) clearance for the IGE ENZYME IMMUNOASSAY TEST KIT CAT.NO. KIF4064. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by Medix Biotech, Inc. (Foster City, US). The FDA issued a Cleared decision on August 5, 1992 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - 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 Medix Biotech, Inc. devices

Submission Details

510(k) Number K922047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1992
Decision Date August 05, 1992
Days to Decision 96 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 104d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DGC Ige, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - DGC Ige, Antigen, Antiserum, Control

All 83
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K922047.
COBAS(R) CORE IGE TOTAL EIA
K930890 · Roche Diagnostic Systems, Inc. · Aug 1993
QUANTA LITE MITOCHONDRIA M2 ELISA
K933180 · Inova Diagnostics, Inc. · Aug 1993
ACCESS(R) TOTAL IGE ASSAY
K930984 · Bio-Rad Laboratories, Inc. · Jun 1993
ACS TOTAL IGE IMMUNOASSAY
K920372 · Ciba Corning Diagnostics Corp. · Apr 1992
KALLESTEAD TOTAL IGE MICROPLATE KIT
K912800 · Bio-Rad Laboratories, Inc. · Jul 1991
PHARMACIA SPECIFIC IGE CONTROL
K911631 · Pharmacia, Inc. · Apr 1991