# K051218: Modification to:  Unicap Specific Ige

- Pathway: 510(k) (Special)
- Applicant: Pharmacia Diagnostics AB
- Decided: Jun 9, 2005 after 28 days
- Product code: DHB (System, Test, Radioallergosorbent (Rast) Immunological)
- Device class: 2
- Regulation: 21 CFR 866.5750
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K962274 (1996). 1 ancestor in all.
30 later devices descend from it; 27 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962274: Unicap 100, Pharmacia, Inc. (1996) Summary page 1.

## Most influential descendants
- K161899: ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls (2016), 1 descendant of its own
- K113841: Immunocap Allergen Components Bundle (2012), 1 descendant of its own
- K101251: Immunocap Allergen D202, Allergen Component Nder P 1, House Dust Mite, Immunocap Allergen D203, Allergen (2011), 1 descendant of its own
- K261027: NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent F017, Hazelnut (Corylus avellana); Capture Reagent F352, Ara h 8 PR-10, Peanut; Capture Reagent F423, Ara h 2, Peanut; Capture Reagent F447, Ara h 6, Peanut (2026), 0 descendants of its own
- K260591: NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture Reagent F020, Almond (Amygdalus communis);Capture Reagent F078, Bos d 8 Casein, Milk; Capture Reagent F080, Lobster (Homarus gammarus);Capture Reagent F422, Ara h 1, Peanut (2026), 0 descendants of its own

## Recalls of this device
- Jul 9, 2019 · Class II · Z-2397-2019: code 7-102 Liquid Sensor Error
- Dec 18, 2017 · Class II · Z-1312-2018: The stability specifications of ImmunoCAP Allergen c5, Ampicilloyl were not met.
- Dec 18, 2017 · Class II · Z-1313-2018: The stability specifications of ImmunoCAP Allergen c6, Amoxicilloyl were not met.

## Indications for use
UniCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma. UniCAP Specific IgE is to be used with the instrument ImmunoCAP/UniCAP 250 and ImmunoCAP/UniCAP 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. The UniCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma. UniCAP Specific IgE is to be used with the instrument ImmunoCAP 100/UniCAP 100. 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, as well as physician office laboratories.

Source page: https://510kreport.com/device/K051218
Methodology: https://510kreport.com/methodology