Cleared Traditional

K934524 - MAST CLA ALLERGY SYSTEM

K934524 is an FDA 510(k) clearance for MAST CLA ALLERGY SYSTEM, manufactured by Mast Immunosystems. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K934524

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
63d slower than avg
Panel avg: 105d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHB Device Classification - Class 2, Special Controls

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 232
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
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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