# K991787: N Latex Ige Mono Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jul 7, 1999 after 43 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 K890530 (1989). 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)
- K890530: N Latex Ige Kit (Immunoglobulin E Reagents), Behring Diagnostics, Inc. (1989) Summary page 1.

## Most influential descendants
- K063425: Dimension Vista Ige Flex Reagent Cartridge, Protein 1 Calibrator, Protein 1 Control Medium, and Protein 1 Control High (2007), 0 descendants of its own

## Indications for use
In vitro diagnostic reagent for the quantitative determination of IgE in human serum or plasma by particle enhanced immunonephelometry using the Behring Nephelometer Systems, and aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Source page: https://510kreport.com/device/K991787
Methodology: https://510kreport.com/methodology