Cleared Special

K133404 - IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH

K133404 is an FDA 510(k) clearance for IMMUNOCAP TOTAL IGE: CONJUGATE, manufactured by Phadia AB. The device is a Class 2 Immunology device with product code DGC cleared through the Special 510(k) pathway after a 110-day FDA review.

K133404 · Phadia AB · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
110d
Days
Class 2
Risk

K133404 is an FDA 510(k) clearance for the IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTRO.... Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by Phadia AB (Portage, US). The FDA issued a Cleared decision on February 24, 2014 after a review of 110 days - within the typical 510(k) review window.

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: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K133404

510(k) Number K133404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2013
Decision Date February 24, 2014
Days to Decision 110 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
5d slower than avg
Panel avg: 105d · This submission: 110d
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 112
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K133404.
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K133404 · IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH
Download PDF FDA Summary Phadia AB