Cleared Traditional

IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS

K111919 · Phadia US, Inc. · Immunology
Dec 2011
Decision
168d
Days
Class 2
Risk

About This 510(k) Submission

K111919 is an FDA 510(k) clearance for the IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS, a System, Test, Radioallergosorbent (rast) Immunological (Class II — Special Controls, product code DHB), submitted by Phadia US, Inc. (Portae, US). The FDA issued a Cleared decision on December 22, 2011, 168 days after receiving the submission on July 7, 2011. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5750.

Submission Details

510(k) Number K111919 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 2011
Decision Date December 22, 2011
Days to Decision 168 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

More from Phadia US, Inc.

View all
ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250
K141375 · DBM · Feb 2015
ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO
K140225 · MOB · Oct 2014
EIA SMDP IMMUNOASSAY
K132631 · LKP · Aug 2014
ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY
K131821 · MID · Dec 2013
AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES
K122197 · DHB · Aug 2013