Cleared Traditional

K024210 - IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR

K024210 is an FDA 510(k) clearance for IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (..., manufactured by Beckman Coulter, Inc.. The device is a Class 2 Immunology device with product code DGC cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K024210 · Beckman Coulter, Inc. · Immunology device
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Optimized for regulatory review, auditing and printing
Feb 2003
Decision
66d
Days
Class 2
Risk

K024210 is an FDA 510(k) clearance for the IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on February 24, 2003 after a review of 66 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Beckman Coulter, Inc. devices

FDA 510(k) Submission Details - K024210

510(k) Number K024210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2002
Decision Date February 24, 2003
Days to Decision 66 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 105d · This submission: 66d
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 90
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K024210.
DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH
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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
RANDOX IGE
K010855 · Randox Laboratories, Ltd. · May 2001
SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT
K002560 · The Binding Site, Ltd. · Oct 2000
BIOCHECK IGE ELISA, MODEL BC-1035
K992528 · Biocheck, Inc. · Sep 1999