510(k) · Cleared

Cleared

Immunocap Specific Ige Allergen Bundle, 12 Allergen Components

K111919510(k) TraditionalCleared Dec 22, 2011168-day reviewClass II21 CFR 866.5750

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Phadia US, Inc. · DHB System, Test, Radioallergosorbent (Rast) Immunological

Cleared on Dec 22, 2011 as substantially equivalent to K051218 (Pharmacia Diagnostics AB, 2005) and 1 other predicate after a 168-day review. Its family tree reaches back 2 generations to 1996.

Decided: Dec 22, 2011
Review: 168 days
Class: Class II
Product code: DHB
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K962274 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK962274 Unicap 100Pharmacia, Inc. · 1996
1 generation backK051218 Modification to: Unicap Specific IgePharmacia Diagnostics AB · 2005 · Recalled
This deviceK111919 Immunocap Specific Ige Allergen Bundle, 12 Allergen ComponentsPhadia US, Inc. · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K962274	Unicap 100	Pharmacia, Inc.	1996	—
−1	K051218	Modification to: Unicap Specific Ige	Pharmacia Diagnostics AB	2005	3
0 (this device)	K111919	Immunocap Specific Ige Allergen Bundle, 12 Allergen Components	Phadia US, Inc.	2011	—

FIG. 1 — Lineage of K111919, 1996–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DHB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DHB device

#1 K260331 IMMULITE 2000 3gAllergy Specific IgE Vantage…score 12.3 · 2 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K051218	Modification to: Unicap Specific Ige Summary page 2 …ts Product Code DHB Class 11 CFR 866.5750 Substantial Equivalence to: ImmunoCAP Specific 1gB (k051218) UniCAP 100 (k962274) Indications For Use Statement ImmunoCAP Specific 1gE is an in vitro quantitative assay…	Pharmacia Diagnostics AB	2005	3
*	K962274	Unicap 100 Summary page 2 …ass 11 CFR 866.5750 Substantial Equivalence to: ImmunoCAP Specific 1gB (k051218) UniCAP 100 (k962274) Indications For Use Statement ImmunoCAP Specific 1gE is an in vitro quantitative assay for the measurement of allergen specific…	Pharmacia, Inc.	1996	—

Also cleared against K051218: 26 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 8.7 years on median.
1 of the 2 ancestors has a recall of any class.
26 other devices also cite its predicate K051218.

How does its category compare?

All DHB devices

DHB System, Test, Radioallergosorbent (Rast) Immunological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · DHB

2in 2025

2007high 7 (2009) · low 0 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DHB

90in 2019

2007high 405 (2011) · low 90 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DHB

14in 2025

2007high 14 (2025) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DHB

6in 2025

2007high 11 (2017) · low 0 (2007)2025

MAUDE reports naming product code DHB, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	0	0
2008	2	—	0	1
2009	7	118	0	0
2010	3	247	0	0
2011	5	405	0	1
2012	3	260	1	2
2013	5	257	0	0
2014	1	—	1	0
2015	1	—	0	1
2016	2	—	0	0
2017	1	—	1	11
2018	2	—	1	6
2019	3	90	0	4
2020	2	—	0	0
2021	1	—	0	7
2022	2	—	3	1
2023	0	—	0	6
2024	0	—	0	10
2025	2	—	14	6
2026	6	138	0	—

What is it indicated for?

immunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma (EDTA or Na-Heparin). immunoCAP Specific IgE is to be used with instruments Phadia 100, Phadia 250, and Phadia 1000. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings, and is to be used in clinical laboratories.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K111919 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111919: Immunocap Specific Ige Allergen Bundle, 12 Allergen Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111919

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026