Cleared Traditional

K874281 - MEDIX BIOTECH IGE VISUAL SCREENING TEST...

K874281 is the FDA 510(k) clearance for MEDIX BIOTECH IGE VISUAL SCREENING TEST... by Medix Biotech, Inc.. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K874281 · Medix Biotech, Inc. · Immunology device
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Dec 1987
Decision
59d
Days
Class 2
Risk

K874281 is an FDA 510(k) clearance for the MEDIX BIOTECH IGE VISUAL SCREENING TEST KIT. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Medix Biotech, Inc. (Foster City, US). The FDA issued a Cleared decision on December 18, 1987 after a review of 59 days - a notably fast clearance cycle.

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: 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 Medix Biotech, Inc. devices

Submission Details

510(k) Number K874281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1987
Decision Date December 18, 1987
Days to Decision 59 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 104d · This submission: 59d
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 199
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K874281.
TOTAL IGE IMMUNO RESPONSE TEST (IRT(R))
K875274 · Incstar Corp. · Feb 1988
MULTI-ALLERGEN IGE FAST SCREEN (MOLDS)
K880002 · 3M Company · Feb 1988
MULTI-ALLERGEN IGE FAST SCREEN (ENVIRONMENTAL)
K874446 · 3M Company · Dec 1987
LIVE OAK ALLERGEN DISC
K874440 · Incstar Corp. · Nov 1987
GIANT RAGWEED ALLERGEN DISC
K873969 · Incstar Corp. · Nov 1987
TOTAL IGE FAST (TM) TEST PACKAGE
K873998 · 3M Company · Nov 1987