# K091539: IQ 200 Urine Analizer Body Fluids Module

- Pathway: 510(k) (Traditional)
- Applicant: Iris Diagnostics
- Decided: Aug 31, 2010 after 462 days
- Product code: GKL (Counter, Cell, Automated (Particle Counter))
- Device class: 2
- Regulation: 21 CFR 864.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K040073 (2004). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091313: Sysmex Model XT-4000I, Sysmex America, Inc. (2010). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K210127: iQ200 System, iChemVELOCITY Automated Urine Chemistry System (2021), 1 descendant of its own
- K252580: iQ200 Series (2025), 0 descendants of its own

## Indications for use
The iQ®200 Urine Analyzer Body Fluids Module is an in-vitro diagnostic device used by an appropriately trained laboratory user to examine and count red blood cells and nucleated cells in cerebrospinal fluid, serous fluids and synovial fluid. This module is a capability added to the iQ®200 Urine Analyzer.

Source page: https://510kreport.com/device/K091539
Methodology: https://510kreport.com/methodology