Cleared Traditional

K190315 - ImmunoCAP Allergen e229

K190315 is the FDA 510(k) clearance for ImmunoCAP Allergen e229 by Phadia AB. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K190315 · Phadia AB · Immunology device
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May 2019
Decision
90d
Days
Class 2
Risk

K190315 is an FDA 510(k) clearance for the ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen .... 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 14, 2019 after a review of 90 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

Submission Details

510(k) Number K190315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2019
Decision Date May 14, 2019
Days to Decision 90 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
14d faster than avg
Panel avg: 104d · This submission: 90d
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 Consultant

Phadia US, Inc.
Sheryl Skinner

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 187
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