# K050493: Quantia Ige

- Pathway: 510(k) (Traditional)
- Applicant: Biokit, S.A.
- Decided: Aug 16, 2005 after 169 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 K964152 (1997). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 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
- K214068: Quantia IgE (2023), 0 descendants of its own

## Indications for use
Quantia IgE is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of Immunoglobulin E concentration in human serum or plasma (EDTA, heparin, citrate) on the AEROSET System. Measurement of IgE is useful in the clinical diagnosis of IgE-mediated allergies, if used in conjunction with other clinical studies. Quantia Ferritin / Myoglobin / IgE control is intended for use in monitoring the quality control of results obtained with Quantia Ferritin, Quantia Myoglobin and Quantia IgE reagents by turbidimetry. (NOTE: These controls were previously FDA cleared for use with quantex Ferritin, reference K040879 and also cleared for use with quantex Myoglobin K042982). For in vitro diagnostic use. Quantia IgE Standard is intended for use in establishing the calibration curve for the Quantia IgE reagents by turbidimetry. For in vitro diagnostic use.

Source page: https://510kreport.com/device/K050493
Methodology: https://510kreport.com/methodology