# K063425: Dimension Vista Ige Flex Reagent Cartridge, Protein 1 Calibrator, Protein 1 Control Medium, and Protein 1 Control High

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Feb 15, 2007 after 94 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: 2 generations back to K890530 (1989). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991787: N Latex Ige Mono Reagent, Dade Behring, Inc. (1999) Summary page 1.
- K012470: Modification to N Protein Standard SL, Dade Behring, Inc. (2001) Summary page 1.
- K012468: Modification to N/T Protein Control SL, Dade Behring, Inc. (2001) Summary page 1.

## Indications for use
The IGE method is an in vitro diagnostic test for the quantitative determination of Immunoglobulin E in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of IGE aid in the diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings. PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin E (IGE), Immunoglobulin G (IGG), Immunoglobulin M (IGM), and Prealbumin (PREALB) methods on the Dimension Vista System. PROT1 CON L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of C3 Complement (C3), C4 Complement (C4), immunoglobulin A (IGA), immunoglobulin E (IGE), immunoglobulin G (IGG), immunoglobulin M (IGM), and prealbumin (PREALB) on the Dimension Vista® System.

Source page: https://510kreport.com/device/K063425
Methodology: https://510kreport.com/methodology