Cleared Traditional

K896592 - CIBA CORNING MAGIC LITE SQ SPECIFIC IGE ASSAY

K896592 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 13-day FDA review.

K896592 · Ciba Corning Diagnostics Corp. · Immunology device
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Dec 1989
Decision
13d
Days
Class 2
Risk

K896592 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 December 4, 1989 after a review of 13 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 Ciba Corning Diagnostics Corp. devices

FDA 510(k) Submission Details - K896592

510(k) Number K896592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1989
Decision Date December 04, 1989
Days to Decision 13 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
92d faster than avg
Panel avg: 105d · This submission: 13d
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 K896592.
3M MULTI-ALLERGEN IGE FASTSCREEN S7, (G3,4,5,6,8)
K897145 · 3M Company · Jan 1990
VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY
K896852 · Ventrex Laboratories, Inc. · Dec 1989
VENTREZYME VAST SPECIFIC IGE ASSAY
K896694 · Ventrex Laboratories, Inc. · Dec 1989
QUIDEL FOOD ALLERGEN SCREEN
K894253 · Quidel Corp. · Jul 1989
PHADEBAS RAST(R)/PHADEZYM(R) RAST ALLERGEN DISC
K893132 · Pharmacia, Inc. · Jun 1989
PHADIATOP PAEDIATRIC RIA AND EIA
K891135 · Pharmacia, Inc. · May 1989