# K972697: Aia-Pack Ige II Assay

- Pathway: 510(k) (Traditional)
- Applicant: Tosoh Medics, Inc.
- Decided: Oct 3, 1997 after 77 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Mar 5, 2018 · Class II · Z-2097-2018: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.

## Indications for use
AIA-PACK IGE II is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of immunoglobulin E (IgE) in human serum on TOSOH AIA System analyzers. Measurements obtained by this device aid in the diagnosis of atopic disorders, allergic conditions and the body’s inability to resist infectious agents.

Source page: https://510kreport.com/device/K972697
Methodology: https://510kreport.com/methodology