Cleared Traditional

K092050 - IMMUNOCAP ALLERGEN D201

K092050 is the FDA 510(k) clearance for IMMUNOCAP ALLERGEN D201 by Phadia AB. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K092050 · Phadia AB · Immunology device
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Nov 2009
Decision
136d
Days
Class 2
Risk

K092050 is an FDA 510(k) clearance for the IMMUNOCAP ALLERGEN D201, HOUSE DUST MITE, MODEL 4-4896-01. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Phadia AB (Portage, US). The FDA issued a Cleared decision on November 20, 2009 after a review of 136 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 K092050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2009
Decision Date November 20, 2009
Days to Decision 136 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
32d slower than avg
Panel avg: 104d · This submission: 136d
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
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