Cleared Traditional

K922047 - IGE ENZYME IMMUNOASSAY TEST KIT CAT.NO. KIF4064

K922047 is an FDA 510(k) clearance for IGE ENZYME IMMUNOASSAY TEST KIT CAT.NO...., manufactured by Medix Biotech, Inc.. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K922047

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
9d faster than avg
Panel avg: 105d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DGC Device Classification - Class 2, Special Controls

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 90
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K922047.
COBAS(R) CORE IGE TOTAL EIA
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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