Cleared Special

K151029 - Phadia Prime (FDA 510(k) Clearance)

Class II Immunology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K151029 · Phadia AB · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2016
Decision
277d
Days
Class 2
Risk

K151029 is an FDA 510(k) clearance for the Phadia Prime. 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 January 19, 2016 after a review of 277 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Phadia AB devices

Submission Details

510(k) Number K151029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2015
Decision Date January 19, 2016
Days to Decision 277 days
Submission Type Special
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
173d slower than avg
Panel avg: 104d · This submission: 277d
Pathway characteristics
Modification to existing cleared device.

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 263
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K151029.
NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea)
K252775 · Hycor Biomedical · Jan 2026
NOVEOS Specific IgE (sIgE)
K252493 · Hycor Biomedical · Dec 2025
NOVEOS Specific IgE (sIgE) Assay
K242531 · Hycor Biomedical · Apr 2025
ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed
K212181 · Phadia AB · Aug 2022
Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria
K220162 · Hycor Biomedical · Feb 2022
Allergen-Specific IgE Assay 12 Allergen Bundle
K193613 · Hitachi Chemical Diagnostics, Inc. · Oct 2021