Cleared Special

K214068 - Quantia IgE

K214068 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 Special 510(k) pathway after a 421-day FDA review.

K214068 · Biokit, S.A. · Immunology device
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Feb 2023
Decision
421d
Days
Class 2
Risk

K214068 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. (Lliçà D´Amunt, ES). The FDA issued a Cleared decision on February 21, 2023 after a review of 421 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - the FDA immunology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Immunology submissions.

View all Biokit, S.A. devices

FDA 510(k) Submission Details - K214068

510(k) Number K214068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2021
Decision Date February 21, 2023
Days to Decision 421 days
Submission Type Special
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
316d slower than avg
Panel avg: 105d · This submission: 421d
Pathway characteristics
Modification to existing cleared device.

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 K214068.
Kenota 1 Total IgE
K231151 · Kenota, Inc. · May 2024
Total Immunoglobulin E (IgE)
K220178 · Beckman Coulter, Inc. · Mar 2022
ADVIA Centaur Total IgE (tIgE)
K193493 · Siemens Healthcare Diagnostics, Inc. · Jan 2020
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