# K121399: Luminex Flexmap 3D Instrument System, Luminex Xponent 4.0 Spi Software, Flexmap 3D Ivd Calibration Kit, Flexmap 3D Ivd P

- Pathway: 510(k) (Traditional)
- Applicant: Luminex Corp.
- Decided: Jan 9, 2013 after 245 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
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.

## Indications for use
The LuminexO FLEXMAP 3D* system with xPONENTI software version 4.0 SPi is a clinical multiplex test system intended to measure and sort multiple signals generated in an in vitro diagnostic assay from a clinical sample. This instrumentation is intended for use with specific IVID cleared or approved assays citing its use, to measure multiple similar analytes that establish a single indicator to aid in diagnosis.

Source page: https://510kreport.com/device/K121399
Methodology: https://510kreport.com/methodology