Cleared Traditional

K896592 - CIBA CORNING MAGIC LITE SQ SPECIFIC IGE...

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
91d faster than avg
Panel avg: 104d · 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 214
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