Cleared Traditional

K163370 - ImmunoCAP Allergen w1

Also marketed or referenced as:
ImmunoCAP Specific IgE

K163370 is the FDA 510(k) clearance for ImmunoCAP Allergen w1 by Phadia AB. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K163370 · Phadia AB · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
155d
Days
Class 2
Risk

K163370 is an FDA 510(k) clearance for the ImmunoCAP Allergen w1, Common ragweed. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Phadia AB (Uppsala, SE). The FDA issued a Cleared decision on May 5, 2017 after a review of 155 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 AB devices

Submission Details

510(k) Number K163370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2016
Decision Date May 05, 2017
Days to Decision 155 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 104d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 188
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K163370.
AP3600 Automated Instrument
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NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus
K182479 · Hycor Biomedical · Dec 2018
ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut
K173726 · Phadia AB · Apr 2018
IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY
K132801 · Siemens Healthcare Diagnostics, Inc. · May 2014
IMMUNOCAP ALLERGEN K82
K121463 · Thermo Fisher Scientific · Jan 2013
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K112523 · Siemens Healthcare Diagnostics, Inc. · Jan 2012