Cleared Traditional

K905054 - CIBA CORNING MODEL 980 MAGIC LITE ALLERGY MANAGER

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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
29d slower than avg
Panel avg: 105d · 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 235
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