Cleared Traditional

K914850 - CHEMILUMINESCENT SYSTEM ALLERGAN SPECIF...

K914850 is the FDA 510(k) clearance for CHEMILUMINESCENT SYSTEM ALLERGAN SPECIF... by Mast Immunosystems. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K914850 · Mast Immunosystems · Immunology device
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Dec 1991
Decision
42d
Days
Class 2
Risk

K914850 is an FDA 510(k) clearance for the CHEMILUMINESCENT SYSTEM ALLERGAN SPECIFIC IGE. 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 December 9, 1991 after a review of 42 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 Mast Immunosystems devices

Submission Details

510(k) Number K914850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1991
Decision Date December 09, 1991
Days to Decision 42 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
62d faster than avg
Panel avg: 104d · This submission: 42d
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 K914850.
VENTREX ALLERGEN DISC
K922538 · Hycor Biomedical, Inc. · Jul 1992
SPECIFIC IGE EIA-TURBO ASSAY
K914554 · Ventrex Laboratories, Inc. · Mar 1992
VENTREX ALLERGEN DISC
K913833 · Ventrex Laboratories, Inc. · Feb 1992
ABBOTT MATRIX AERO PLUS SYSTEM
K913150 · Abbott Laboratories · Nov 1991
ALLERGY INFORMATION MANAGER
K912294 · Diagnostic Products Corp. · Nov 1991
ALLERGANS PHARMACIA CAP SYS.RAST RIA/FEIA
K911903 · Pharmacia, Inc. · Aug 1991