# K983185: Boehringer Mannheim Tina-Quant Ige Test

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Nov 12, 1998 after 62 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
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. The FDA summary names its predicate without a number.
- (no number) Behring N IgE test: named in the summary without a submission number

## Indications for use
For the quantitative in vitro determination of IgE in human serum and plasma on automated clinical chemistry analyzers. IgE determinations are used as an aid in the diagnosis of allergic diseases.

Source page: https://510kreport.com/device/K983185
Methodology: https://510kreport.com/methodology