# K093128: Illumina Beadxpress System

- Pathway: 510(k) (Traditional)
- Applicant: Illumina, Inc.
- Decided: Apr 28, 2010 after 208 days
- Product code: NSU (Instrumentation For Clinical Multiplex Test Systems)
- Device class: 2
- Regulation: 21 CFR 862.2570
- 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 K060564 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060564: Infiniti System, AutoGenomics, Inc. (2007) Summary page 4.

## Indications for use
The BeadXpress® System is an in vitro diagnostic device intended for the simultaneous detection of multiple analytes in a DNA sample utilizing VeraCode holographic microbead technology. The BeadXpress System consists of the BeadXpress Reader and VeraScan software.

Source page: https://510kreport.com/device/K093128
Methodology: https://510kreport.com/methodology