# K050235: IQ 200 Urine Analyzer Body Fluids Module

- Pathway: 510(k) (Traditional)
- Applicant: Iris International, Inc.
- Decided: Mar 23, 2005 after 50 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: 1 generation back to K914256 (1992). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914256: Yellow Iris Urinalysis Wrksta W/Iriscope Bdy Flu, Intl. Remote Imaging Systems (1992) Summary page 2.
- K934539: The Yellow Iris Urinalysis Workstation with Iriscope Body Fluid Analysis Capability, Intl. Remote Imaging Systems (1994) Summary page 2.
- K954006: Yellow Iris Urinalysis Workstation W/Iriscope Body Fluid Analysis Capability, Intl. Remote Imaging Systems (1996) Summary page 2.
- K040073: Sysmex Automated Hematology Analyzer, XE-2100 Series (XE-2100, XE-2100L), Sysmex America, Inc. (2004) Summary page 2.
- (no number) Manual body fluid microscopic cell-count examination by a competent observer using a light microscope: named in the summary without a submission number

## 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 a competent human observer to examine and count red blood cells and nucleated cells in cerebrospinal fluid and serous fluids. Cerebrospinal fluid analysis is ordered by physicians to diagnose meningitis, intracranial hemorrhage, leukemias, malignancies and central nervous system disorders. Serous fluid analysis is ordered by physicians to diagnose infections, hemorrhages, malignancies and other disorders. Cell count determination is a part of these analyses. The information produced by the iQ 200 Urine Analyzer Body Fluids Module concerning the cell concentrations in CSF and serous body fluids is ordered at the discretion of the physician, and is part of a larger body of laboratory and other test results available to assist the physician in health assessments or differential diagnoses. Cell count findings are always subject to judgment and interpretation by physicians relative to the patient's overall clinical presentation and history.

Source page: https://510kreport.com/device/K050235
Methodology: https://510kreport.com/methodology