Cleared Traditional

K111919 - IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE

K111919 is an FDA 510(k) clearance for IMMUNOCAP SPECIFIC IGE ALLERGEN 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 168-day FDA review.

K111919 · Phadia US, Inc. · Immunology device
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Dec 2011
Decision
168d
Days
Class 2
Risk

K111919 is an FDA 510(k) clearance for the IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS. 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 December 22, 2011 after a review of 168 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 - K111919

510(k) Number K111919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2011
Decision Date December 22, 2011
Days to Decision 168 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: 104d · This submission: 168d
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 K111919.
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K121463 · Thermo Fisher Scientific · Jan 2013
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K113841 · Phadia US, Inc. · Sep 2012
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K112523 · Siemens Healthcare Diagnostics, Inc. · Jan 2012
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K101572 · Siemens Healthcare Diagnostics · Aug 2011
IMMUNOCAP ALLERGEN D202, ALLERGEN COMPONENT NDER P 1, HOUSE DUST MITE, IMMUNOCAP ALLERGEN D203, ALLERGEN
K101251 · Phadia AB · May 2011
IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6
K093987 · Siemens Healthcare Diagnostics, Inc. · Mar 2011