Cleared Traditional

K853607 - ALLERG-E IGE ENZYME IMMUNOASSAY KIT

K853607 is the FDA 510(k) clearance for ALLERG-E IGE ENZYME IMMUNOASSAY KIT by Dexall Biomedical Labs, Inc.. It is a Class 2 Immunology device (product code DGO) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K853607 · Dexall Biomedical Labs, Inc. · Immunology device
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Nov 1985
Decision
71d
Days
Class 2
Risk

K853607 is an FDA 510(k) clearance for the ALLERG-E IGE ENZYME IMMUNOASSAY KIT. Classified as Ige, Peroxidase, Antigen, Antiserum, Control (product code DGO), Class II - Special Controls.

Submitted by Dexall Biomedical Labs, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on November 7, 1985 after a review of 71 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dexall Biomedical Labs, Inc. devices

Submission Details

510(k) Number K853607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1985
Decision Date November 07, 1985
Days to Decision 71 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 104d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 9
Devices cleared under the same product code (DGO) and FDA review panel - the closest regulatory comparables to K853607.
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
EPSILON IGE TEST KIT
K831987 · Beckman Instruments, Inc. · Oct 1983
IMMUNOGLOBULIN E TEST KIT
K800995 · Calbiochem-Behring Corp. · May 1980