Cleared Traditional

K050493 - QUANTIA IGE

K050493 is an FDA 510(k) clearance for QUANTIA IGE, manufactured by Biokit, S.A.. The device is a Class 2 Immunology device with product code DGC cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K050493 · Biokit, S.A. · Immunology device
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Aug 2005
Decision
169d
Days
Class 2
Risk

K050493 is an FDA 510(k) clearance for the QUANTIA IGE. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by Biokit, S.A. (Barcelona, ES). The FDA issued a Cleared decision on August 16, 2005 after a review of 169 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 Biokit, S.A. devices

FDA 510(k) Submission Details - K050493

510(k) Number K050493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2005
Decision Date August 16, 2005
Days to Decision 169 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
64d slower than avg
Panel avg: 105d · This submission: 169d
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 K050493.
ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls
K161899 · Phadia AB · Jul 2016
IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH
K133404 · Phadia AB · Feb 2014
DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH
K063425 · Dade Behring, Inc. · Feb 2007
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