# K032251: Immunetech Total Ige System

- Pathway: 510(k) (Traditional)
- Applicant: Immunetech Corporation
- Decided: Dec 19, 2003 after 150 days
- Product code: DGC (Ige, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K991945 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020387: Myallergytest System, Immunetech Corporation (2002) Summary page 2.
- K991945: Pharmacia Cap System Ige Feia, Model 10-9395-01, Pharmacia & Upjohn Co. (1999) Summary page 2.

## Indications for use
The ImmuneTechTM Total IgE System is a quantitative in vitro diagnostic test system that measures total IgE in human serum. The ImmuneTechTM Total IgE System is intended for clinical laboratory use. The ImmuneTechT M Total IgE System may only be run on the Luminex 100TM Integrated System.

Source page: https://510kreport.com/device/K032251
Methodology: https://510kreport.com/methodology