# 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

- Pathway: 510(k) (Special)
- Applicant: Phadia AB
- Decided: Jul 28, 2016 after 17 days
- Product code: DGC (Ige, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5510
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K962274 (1996). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051218: Modification to:  Unicap Specific Ige, Pharmacia Diagnostics AB (2005) Summary page 5.
- K133404: Immunocap Total Ige: Conjugate, Anti-Ige, Calibrators, Curve Controls, Control LMH, Phadia AB (2014) Summary page 6.

## Most influential descendants
- K231151: Kenota 1 Total IgE; Kenota 1 (instrument) (2024), 0 descendants of its own

## Recalls of this device
- Jul 5, 2017 · Class II · Z-0387-2018: The "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results.

## Indications for use
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, Phadia 1000, Phadia 2500 and Phadia 5000. 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. ImmunoCAP Total IgE is an in vitro test system for the quantitative measurement of circulating total IgE in human serum and plasma. 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. ImmunoCAP Total IgE is to be used with the instruments Phadia 100, Phadia 250, Phadia 1000, Phadia 2500 or Phadia 5000.

Source page: https://510kreport.com/device/K161899
Methodology: https://510kreport.com/methodology