# K972141: The Yellow Iris Urinalysis Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Intl. Remote Imaging Systems
- Decided: Aug 25, 1997 after 80 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.
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. The FDA summary names no predicate by number.

## Indications for use
The Yellow IRIS is used by a competent human operator to produce a complete urinalysis profile, including chemistry, sediment microscopy and specific gravity determinations. It is capable of detecting and reporting all types of formed urine sediment elements and of quantitating such elements, when desired, based on observed proportion of total particulate count. The Yellow IRIS is intended to replace the conventional intensive manipulatively manual complete urinalysis procedure as well as the abbreviated.

Source page: https://510kreport.com/device/K972141
Methodology: https://510kreport.com/methodology