Cleared Traditional

MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM (K914959) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K914959 · Ciba Corning Diagnostics Corp. · Immunology device
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Aug 1992
Decision
289d
Days
Class 2
Risk

K914959 is an FDA 510(k) clearance for the MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Ciba Corning Diagnostics Corp. (East Walpole, US). The FDA issued a Cleared decision on August 20, 1992 after a review of 289 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 Ciba Corning Diagnostics Corp. devices

Submission Details

510(k) Number K914959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1991
Decision Date August 20, 1992
Days to Decision 289 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
185d slower than avg
Panel avg: 104d · This submission: 289d
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 104
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K914959.
IMMULITE ALATOP ALLERGY SCREEN
K941564 · Diagnostic Products Corp. · Dec 1994
ALATOP(R) MICROPLATE ALLERGY SCREEN
K935488 · Diagnostic Products Corp. · Mar 1994
CIBA CORNING MAGIC LITE SQ SPECIFIC IGE ASSAY
K923420 · Ciba Corning Diagnostics Corp. · Feb 1993
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