Cleared Traditional

K943194 - IMMULITE(R) ALLERGY FOOD PANEL FP5E

K943194 is an FDA 510(k) clearance for IMMULITE ALLERGY FOOD PANEL FP5E, manufactured by Diagnostic Products Corp.. The device is a Class 2 Immunology device with product code DGO cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K943194 · Diagnostic Products Corp. · Immunology device
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Feb 1995
Decision
233d
Days
Class 2
Risk

K943194 is an FDA 510(k) clearance for the IMMULITE(R) ALLERGY FOOD PANEL FP5E. Classified as Ige, Peroxidase, Antigen, Antiserum, Control (product code DGO), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on February 23, 1995 after a review of 233 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 Diagnostic Products Corp. devices

FDA 510(k) Submission Details - K943194

510(k) Number K943194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1994
Decision Date February 23, 1995
Days to Decision 233 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
128d slower than avg
Panel avg: 105d · This submission: 233d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DGO Device Classification - Class 2, Special Controls

Product Code DGO Ige, Peroxidase, 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 - DGO Ige, Peroxidase, Antigen, Antiserum, Control

All 8
Devices cleared under the same product code (DGO) and FDA review panel - the closest regulatory comparables to K943194.
IGE EIA TEST KIT
K920087 · The Binding Site, Ltd. · Sep 1992
ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIED
K911511 · Diagnostic Products Corp. · Apr 1991
QUIDEL TOTAL IGE TEST QUANTITATIVE VERSION
K894039 · Quidel Corp. · Jul 1989
BECKMAN EPSILON(TM) IGE REAGENT KIT
K893125 · Beckman Instruments, Inc. · Jun 1989
ALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 5
K872801 · Diagnostic Products Corp. · Sep 1987
ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEM
K860851 · Nichols Institute Diagnostics · Mar 1986