Cleared Traditional

K920087 - IGE EIA TEST KIT

K920087 is an FDA 510(k) clearance for IGE EIA TEST KIT, manufactured by The Binding Site, Ltd.. The device is a Class 2 Immunology device with product code DGO cleared through the Traditional 510(k) pathway after a 250-day FDA review.

K920087 · The Binding Site, Ltd. · Immunology device
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Sep 1992
Decision
250d
Days
Class 2
Risk

K920087 is an FDA 510(k) clearance for the IGE EIA TEST KIT. Classified as Ige, Peroxidase, Antigen, Antiserum, Control (product code DGO), Class II - Special Controls.

Submitted by The Binding Site, Ltd. (Los Angeles, US). The FDA issued a Cleared decision on September 14, 1992 after a review of 250 days - an extended review cycle.

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 The Binding Site, Ltd. devices

FDA 510(k) Submission Details - K920087

510(k) Number K920087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1992
Decision Date September 14, 1992
Days to Decision 250 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 105d · This submission: 250d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DGO Device Classification - Class 2, Special Controls

Product Code DGO Ige, Peroxidase, 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 - DGO Ige, Peroxidase, Antigen, Antiserum, Control

All 8
Devices cleared under the same product code (DGO) and FDA review panel - the closest regulatory comparables to K920087.
IMMULITE(R) ALLERGY FOOD PANEL FP5E
K943194 · Diagnostic Products Corp. · Feb 1995
ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIED
K911511 · Diagnostic Products Corp. · Apr 1991
QUIDEL TOTAL IGE TEST QUANTITATIVE VERSION
K894039 · Quidel Corp. · Jul 1989
BECKMAN EPSILON(TM) IGE REAGENT KIT
K893125 · Beckman Instruments, Inc. · Jun 1989
ALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 5
K872801 · Diagnostic Products Corp. · Sep 1987
ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEM
K860851 · Nichols Institute Diagnostics · Mar 1986