Cleared Traditional

K864696 - ALLERG*ENS ENZYME IMMUNOASSAY KIT

K864696 is the FDA 510(k) clearance for ALLERG*ENS ENZYME IMMUNOASSAY KIT by Dexall Biomedical Labs, Inc.. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K864696 · Dexall Biomedical Labs, Inc. · Immunology device
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Mar 1987
Decision
106d
Days
Class 2
Risk

K864696 is an FDA 510(k) clearance for the ALLERG*ENS ENZYME IMMUNOASSAY KIT. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Dexall Biomedical Labs, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on March 17, 1987 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5750 - 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 Dexall Biomedical Labs, Inc. devices

Submission Details

510(k) Number K864696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1986
Decision Date March 17, 1987
Days to Decision 106 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 104d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DHB System, Test, Radioallergosorbent (rast) Immunological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5750
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 - DHB System, Test, Radioallergosorbent (rast) Immunological

All 200
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K864696.
VENTRESCREEN CAT/DOG ALLERGY TEST KIT ENZYME IMMU.
K871331 · Ventrex Laboratories, Inc. · Apr 1987
VENTRESCREEN MITE/MOLD ALLERGY TEST KIT ENZYME IM.
K870009 · Ventrex Laboratories, Inc. · Apr 1987
VENTREX IP SPECIFIC E ENZYME IMMUNOASSAY
K870624 · Ventrex Laboratories, Inc. · Mar 1987
D. FARINAE ALLERGEN DISC
K870597 · Incstar Corp. · Mar 1987
CAT EPITHELIUM ALLERGEN DISC
K870264 · Incstar Corp. · Feb 1987
ADDITONAL ALLERGENS FOR IGE FAST (TM) TEST
K864104 · 3M Company · Feb 1987