Cleared Traditional

K934594 - MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY ...

K934594 is an FDA 510(k) clearance for MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY ..., manufactured by Ciba Corning Diagnostics Corp.. The device is a Class 2 Immunology device with product code DGC cleared through the Traditional 510(k) pathway after a 209-day FDA review.

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

FDA 510(k) Submission Details - K934594

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.

DGC Device Classification - Class 2, Special Controls

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 86
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K934594.
AIA-PACK IGE II ASSAY
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UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH
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HY-TEC TOTAL IGE ENZYME IMMUNOASSAY
K940183 · Hycor Biomedical, Inc. · May 1994
COBAS(R) CORE IGE TOTAL EIA
K930890 · Roche Diagnostic Systems, Inc. · Aug 1993
QUANTA LITE MITOCHONDRIA M2 ELISA
K933180 · Inova Diagnostics, Inc. · Aug 1993
ACCESS(R) TOTAL IGE ASSAY
K930984 · Bio-Rad Laboratories, Inc. · Jun 1993