Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

DHB — Predicate Candidate Screening

268 FDA 510(k) clearances under this product code; the 50 most recent screened below.

77 daysmedian FDA review time

252 days90th percentile

268clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K261027	NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (G	Hycor Biomedical	2026-07-24	116	0
K260591	NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed	Hycor Biomedical	2026-07-21	148	0
K260280	NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Tri	Hycor Biomedical	2026-06-18	140	0
K260059	NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut	Hycor Biomedical	2026-05-15	127	0
K252775	NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Ar	Hycor Biomedical	2026-01-16	136	0
K252493	NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Sh	Hycor Biomedical	2025-12-23	137	0
K242531	NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, John	Hycor Biomedical	2025-04-23	240	0
K212181	ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, W	Phadia AB	2022-08-03	386	0
K220162	Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Ca	Hycor Biomedical	2022-02-18	29	0
K193613	Allergen-Specific IgE Assay 12 Allergen Bundle	Hitachi Chemical Diagnostics, Inc.	2021-10-18	662	0
K200825	NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E00	Hycor Biomedical	2020-06-26	88	0
K200279	ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-	Phadia AB	2020-05-01	87	0
K191510	Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Ca	Hycor Biomedical	2019-07-31	55	0
K190315	ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, Im	Phadia AB	2019-05-14	90	0
K182793	AP3600 Automated Instrument	Hitachi Chemical Diagnostics, Inc.	2019-03-19	169	0
K182479	NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assa	Hycor Biomedical	2018-12-04	85	0
K173726	ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Co	Phadia AB	2018-04-16	132	0
K163370	ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific Ig	Phadia AB	2017-05-05	155	0
K150597	ImmunoCAP Allergen d202, Allergen component rDer p 1,House d	Phadia AB	2016-02-29	357	0
K151029	Phadia Prime	Phadia AB	2016-01-19	277	0
K150854	ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; I	Phadia AB	2015-12-14	258	0
K132801	IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY	Siemens Healthcare Diagnostics, Inc.	2014-05-28	257	0
K122197	AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF	Phadia US, Inc.	2013-08-28	400	1
K131738	IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CON	Phadia AB	2013-07-10	27	1
K123275	IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AN	Phadia AB	2013-06-28	252	1
K121156	AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF	Phadia AB	2013-03-13	331	1
K121463	IMMUNOCAP ALLERGEN K82	Thermo Fisher Scientific	2013-01-29	257	1
K112910	AP 72OS SEMI-AUTOMATED INSTRUMENT	Hitachi Chemical Diagnostics, Inc.	2012-12-20	444	0
K113841	IMMUNOCAP ALLERGEN COMPONENTS BUNDLE	Phadia US, Inc.	2012-09-13	260	0
K112523	IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT	Siemens Healthcare Diagnostics, Inc.	2012-01-06	128	0
K111919	IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONEN	Phadia US, Inc.	2011-12-22	168	0
K101572	IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT	Siemens Healthcare Diagnostics	2011-08-01	423	4
K101251	IMMUNOCAP ALLERGEN D202, ALLERGEN COMPONENT NDER P 1, HOUSE	Phadia AB	2011-05-27	388	0
K100910	IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6	Siemens Medical Solutions Diagnostics	2011-05-11	405	0
K093987	IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6	Siemens Healthcare Diagnostics, Inc.	2011-03-28	459	0
K100999	IMMUNOCAP ALLERGEN F20, ALMOND MODEL: 14-4179-01	Phadia AB	2010-12-15	247	0
K093107	IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT	Siemens Healthcare Diagnostics	2010-09-30	364	0
K092978	IMMUNOCAP RAPID READER, MODEL 12-3600-10	Phadia US, Inc.	2010-01-19	113	0
K092050	IMMUNOCAP ALLERGEN D201, HOUSE DUST MITE, MODEL 4-4896-01	Phadia AB	2009-11-20	136	0
K091984	IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6	Siemens Medical Solutions Diagnostics	2009-10-28	118	0
K091289	IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT	Siemens Healthcare Diagnostics	2009-08-06	97	0
K090257	IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT	Siemens Healthcare Diagnostics	2009-05-26	113	0
K083853	IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT	Siemens Healthcare Diagnostics	2009-03-24	90	0
K081830	IMMUNOCAP RAPID INHALANT PROFILE , IMMUNOCAP RAPID READER, I	Phadia AB	2009-03-16	259	0
K083314	IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT	Siemens Healthcare Diagnostics	2009-03-11	121	0
K081217	HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM	Hycor Biomedical, Inc.	2008-05-22	22	0
K080322	HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREE	Hycor Biomedical, Inc.	2008-03-05	28	0
K071913	IMMUNOCAP ALLERGEN F338, SCALLOP WITH MODEL(S): 14-4895-01	Phadia AB	2007-08-24	44	0
K051677	OPTIGEN ALLERGEN SPECIFIC IGE ASSAY	Hitachi Chemical Diagnostics, Inc.	2006-01-23	216	1
K051218	MODIFICATION TO: UNICAP SPECIFIC IGE	Pharmacia Diagnostics AB	2005-06-09	28	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda