Cleared Traditional

K934524 - MAST CLA ALLERGY SYSTEM

K934524 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 168-day FDA review.

K934524 · Mast Immunosystems · Immunology device
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Mar 1994
Decision
168d
Days
Class 2
Risk

K934524 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 168 days - an extended review 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: 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 Mast Immunosystems devices

Submission Details

510(k) Number K934524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1993
Decision Date March 07, 1994
Days to Decision 168 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
64d slower than avg
Panel avg: 104d · This submission: 168d
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 K934524.
IMMULITE ALATOP ALLERGY SCREEN
K941564 · Diagnostic Products Corp. · Dec 1994
ALATOP(R) MICROPLATE ALLERGY SCREEN
K935488 · Diagnostic Products Corp. · Mar 1994
ACCESS SPECIFIC IGE ASSAY
K935876 · Bio-Rad Laboratories, Inc. · Mar 1994
CIBA CORNING MAGIC LITE SQ SPECIFIC IGE ASSAY
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