Cleared Traditional

MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM (K934594) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K934594 · Ciba Corning Diagnostics Corp. · Immunology device
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Apr 1994
Decision
209d
Days
Class 2
Risk

K934594 is an FDA 510(k) clearance for the MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by Ciba Corning Diagnostics Corp. (East Walpole, US). The FDA issued a Cleared decision on April 21, 1994 after a review of 209 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - 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

Submission Details

510(k) Number K934594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1993
Decision Date April 21, 1994
Days to Decision 209 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
105d slower than avg
Panel avg: 104d · This submission: 209d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DGC Ige, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 - DGC Ige, Antigen, Antiserum, Control

All 42
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K934594.
N LATEX IGE MONO REAGENT
K991787 · Dade Behring, Inc. · Jul 1999
BOEHRINGER MANNHEIM TINA-QUANT IGE TEST
K983185 · Boehringer Mannheim Corp. · Nov 1998
UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH
K964152 · Pharmacia, Inc. · Apr 1997
COBAS(R) CORE IGE TOTAL EIA
K930890 · Roche Diagnostic Systems, Inc. · Aug 1993
QUANTA LITE MITOCHONDRIA M2 ELISA
K933180 · Inova Diagnostics, Inc. · Aug 1993
ACS TOTAL IGE IMMUNOASSAY
K920372 · Ciba Corning Diagnostics Corp. · Apr 1992