Cleared Traditional

ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite

K150597 · Phadia AB · Immunology
Feb 2016
Decision
357d
Days
Class 2
Risk

About This 510(k) Submission

K150597 is an FDA 510(k) clearance for the ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite, a System, Test, Radioallergosorbent (rast) Immunological (Class II — Special Controls, product code DHB), submitted by Phadia AB (Uppsala, SE). The FDA issued a Cleared decision on February 29, 2016, 357 days after receiving the submission on March 9, 2015. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5750.

Submission Details

510(k) Number K150597 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 2015
Decision Date February 29, 2016
Days to Decision 357 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DHB — System, Test, Radioallergosorbent (rast) Immunological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5750

Similar Devices — DHB System, Test, Radioallergosorbent (rast) Immunological

All 263
NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin, Milk; Capture Reagent F077, Bos d 5 ?-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, Egg
K252775 · Hycor Biomedical · Jan 2026
NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica)
K252493 · Hycor Biomedical · Dec 2025
NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz
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