# K073506: Luminex LX 100/200 Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Luminex Corp.
- Decided: Mar 7, 2008 after 85 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.
2 later devices descend 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K113830: Vantera Clinical Analyzer (2012), 1 descendant of its own
- K133849: Vantera Clinical Analyzer (2014), 0 descendants of its own

## Indications for use
The Luminex LX 100/200 Instrument 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 used with a specific assay to measure multiple similar analytes that establish a single indicator to aid in diagnosis. The device includes a signal reader unit, raw data storage mechanisms, data acquisition software and software to process detected signals.

Source page: https://510kreport.com/device/K073506
Methodology: https://510kreport.com/methodology