Cleared Traditional

K113841 - IMMUNOCAP ALLERGEN COMPONENTS BUNDLE

K113841 is an FDA 510(k) clearance for IMMUNOCAP ALLERGEN COMPONENTS BUNDLE, manufactured by Phadia US, Inc.. The device is a Class 2 Immunology device with product code DHB cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K113841 · Phadia US, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
260d
Days
Class 2
Risk

K113841 is an FDA 510(k) clearance for the IMMUNOCAP ALLERGEN COMPONENTS BUNDLE. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Phadia US, Inc. (Portage, US). The FDA issued a Cleared decision on September 13, 2012 after a review of 260 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5750 - 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 Phadia US, Inc. devices

FDA 510(k) Submission Details - K113841

510(k) Number K113841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2011
Decision Date September 13, 2012
Days to Decision 260 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
156d slower than avg
Panel avg: 104d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHB Device Classification - Class 2, Special Controls

Product Code DHB System, Test, Radioallergosorbent (rast) Immunological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5750
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 - DHB System, Test, Radioallergosorbent (rast) Immunological

All 218
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K113841.
IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN i4, PAPER WASP VENOM
K123275 · Phadia AB · Jun 2013
AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES
K121156 · Phadia AB · Mar 2013
IMMUNOCAP ALLERGEN K82
K121463 · Thermo Fisher Scientific · Jan 2013
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K112523 · Siemens Healthcare Diagnostics, Inc. · Jan 2012
IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS
K111919 · Phadia US, Inc. · Dec 2011
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K101572 · Siemens Healthcare Diagnostics · Aug 2011