Cleared Traditional

K923420 - CIBA CORNING MAGIC LITE SQ SPECIFIC IGE...

K923420 is an FDA 510(k) clearance for CIBA CORNING MAGIC LITE SQ SPECIFIC IGE..., 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 225-day FDA review.

K923420 · Ciba Corning Diagnostics Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1993
Decision
225d
Days
Class 2
Risk

K923420 is an FDA 510(k) clearance for the CIBA CORNING MAGIC LITE SQ SPECIFIC IGE ASSAY. 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 February 23, 1993 after a review of 225 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

FDA 510(k) Submission Details - K923420

510(k) Number K923420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1992
Decision Date February 23, 1993
Days to Decision 225 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
121d slower than avg
Panel avg: 104d · This submission: 225d
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 K923420.
IMMULITE ALATOP ALLERGY SCREEN
K941564 · Diagnostic Products Corp. · Dec 1994
ALATOP(R) MICROPLATE ALLERGY SCREEN
K935488 · Diagnostic Products Corp. · Mar 1994
ACCESS SPECIFIC IGE ASSAY
K935876 · Bio-Rad Laboratories, Inc. · Mar 1994
SPECIFIC IGE EIA-TURBO ASSAY
K925425 · Hycor Biomedical, Inc. · Jan 1993
VENTREX ALLERGEN DISC
K924044 · Hycor Biomedical, Inc. · Dec 1992
VENTREX ALLERGEN DISC
K924209 · Hycor Biomedical, Inc. · Nov 1992