Cleared Traditional

K943194 - IMMULITE ALLERGY FOOD PANEL FP5E

K943194 is the FDA 510(k) clearance for IMMULITE ALLERGY FOOD PANEL FP5E by Diagnostic Products Corp.. It is a Class 2 Immunology device (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

Submission Details

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
129d slower than avg
Panel avg: 104d · This submission: 233d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 7
Devices cleared under the same product code (DGO) and FDA review panel - the closest regulatory comparables to K943194.
IGE EIA TEST KIT
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ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIED
K911511 · Diagnostic Products Corp. · Apr 1991
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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