Cleared Traditional

K926420 - MAST CLA ALLERGY SYSTEM

K926420 is the FDA 510(k) clearance for MAST CLA ALLERGY SYSTEM by Mast Immunosystems. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 439-day FDA review.

K926420 · Mast Immunosystems · Immunology device
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Mar 1994
Decision
439d
Days
Class 2
Risk

K926420 is an FDA 510(k) clearance for the MAST CLA ALLERGY SYSTEM. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Mast Immunosystems (Mountain View, US). The FDA issued a Cleared decision on March 7, 1994 after a review of 439 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Immunology submissions.

View all Mast Immunosystems devices

Submission Details

510(k) Number K926420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1992
Decision Date March 07, 1994
Days to Decision 439 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
335d slower than avg
Panel avg: 104d · This submission: 439d
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 K926420.
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K923420 · Ciba Corning Diagnostics Corp. · Feb 1993
SPECIFIC IGE EIA-TURBO ASSAY
K925425 · Hycor Biomedical, Inc. · Jan 1993
VENTREX ALLERGEN DISC
K924044 · Hycor Biomedical, Inc. · Dec 1992