# K133404: Immunocap Total Ige: Conjugate, Anti-Ige, Calibrators, Curve Controls, Control LMH

- Pathway: 510(k) (Special)
- Applicant: Phadia AB
- Decided: Feb 24, 2014 after 110 days
- Product code: DGC (Ige, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5510
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K964152 (1997). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964152: Unicap Total Ige Assay/Pharmacia Total Ige Controls LMH, Pharmacia, Inc. (1997) 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
- 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.
- Nov 20, 2014 · Class II · Z-0947-2015: During an investigation of instrument logs it was determined that In specific circumstances involving multiple steps, a rack sequencing error may occur. This will result in a mismatch between the samp

## Indications for use
ImmunoCAP Total IgE is an in vitro test system for the quantitative measurement of circulating total IgE in human serum or 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. ImmunoCAP Total IgE Control LMH is used for monitoring ImmunoCAP Total IgE measurements performance in Phadia instruments.

Source page: https://510kreport.com/device/K133404
Methodology: https://510kreport.com/methodology