Cleared Traditional

K905054 - CIBA CORNING MODEL 980 MAGIC LITE ALLER...

K905054 is an FDA 510(k) clearance for CIBA CORNING MODEL 980 MAGIC LITE ALLER..., manufactured by Ciba Corning Diagnostics Corp.. The device is a Class 2 Immunology device with product code DHB cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K905054 · Ciba Corning Diagnostics Corp. · Immunology device
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Mar 1991
Decision
134d
Days
Class 2
Risk

K905054 is an FDA 510(k) clearance for the CIBA CORNING MODEL 980 MAGIC LITE ALLERGY MANAGER. 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 March 22, 1991 after a review of 134 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K905054

510(k) Number K905054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1990
Decision Date March 22, 1991
Days to Decision 134 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 104d · This submission: 134d
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 214
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K905054.
ALLERGANS PHARMACIA CAP SYS.RAST RIA/FEIA
K911903 · Pharmacia, Inc. · Aug 1991
MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM
K912582 · Ciba Corning Diagnostics Corp. · Jul 1991
ALLERGEN MODULES FOR ALASTAT TM
K894227 · Diagnostic Products Corp. · Apr 1991
CAP SYSTEM RAST ASM/RIA AND ASM/FEIA
K910517 · Pharmacia, Inc. · Mar 1991
VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY
K905636 · Ventrex Laboratories, Inc. · Feb 1991
SPECIFIC ALLERGEN MODULES FOR ALASTAT ALLERGEN IGE
K910075 · Diagnostic Products Corp. · Jan 1991