Cleared Traditional

K173726 - ImmunoCAP Specific IgE

K173726 is an FDA 510(k) clearance for ImmunoCAP Specific IgE, manufactured by Phadia AB. The device is a Class 2 Immunology device with product code DHB cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K173726 · Phadia AB · Immunology device
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Optimized for regulatory review, auditing and printing
Apr 2018
Decision
132d
Days
Class 2
Risk

K173726 is an FDA 510(k) clearance for the ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6,.... 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 April 16, 2018 after a review of 132 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K173726

510(k) Number K173726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2017
Decision Date April 16, 2018
Days to Decision 132 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
28d slower than avg
Panel avg: 104d · This submission: 132d
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 Consultant

Phadia US, Inc.
Martin Mann

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K173726.
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