Cleared Traditional

K032251 - IMMUNETECH TOTAL IGE SYSTEM

K032251 is an FDA 510(k) clearance for IMMUNETECH TOTAL IGE SYSTEM, manufactured by Immunetech Corporation. The device is a Class 2 Immunology device with product code DGC cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K032251 · Immunetech Corporation · Immunology device
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Dec 2003
Decision
150d
Days
Class 2
Risk

K032251 is an FDA 510(k) clearance for the IMMUNETECH TOTAL IGE SYSTEM. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by Immunetech Corporation (Rancho Santa Fe, US). The FDA issued a Cleared decision on December 19, 2003 after a review of 150 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 Immunetech Corporation devices

FDA 510(k) Submission Details - K032251

510(k) Number K032251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2003
Decision Date December 19, 2003
Days to Decision 150 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 105d · This submission: 150d
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 91
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K032251.
DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH
K063425 · Dade Behring, Inc. · Feb 2007
QUANTIA IGE
K050493 · Biokit, S.A. · Aug 2005
K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C
K042241 · Kamiya Biomedical Co. · Dec 2004
IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR
K024210 · Beckman Coulter, Inc. · Feb 2003
RANDOX IGE
K010855 · Randox Laboratories, Ltd. · May 2001
SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT
K002560 · The Binding Site, Ltd. · Oct 2000