# K960054: 900UDX Urine Pathology System

- Pathway: 510(k) (Traditional)
- Applicant: Intl. Remote Imaging Systems
- Decided: Mar 22, 1996 after 78 days
- Product code: KQO (Automated Urinalysis System)
- Device class: 1
- Regulation: 21 CFR 862.2900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) The Yellow IRIS® Urinalysis Workstation with CHEMSTRIP® Reader: named in the summary without a submission number
- (no number) IRIS Flow Microscope: named in the summary without a submission number

## Most influential descendants
- K101852: Chem Velocity Automated Urine Chemistry System, Strips and Calchek Kit (2011), 3 descendants of its own
- K171083: iChemVELOCITY Automated Urine Chemistry System (2017), 2 descendants of its own
- 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 900UDx Urine Pathology System performs routine urinalysis, including urine chemistry, specific gravity, and sediment microscopic examination.

Source page: https://510kreport.com/device/K960054
Methodology: https://510kreport.com/methodology