# K093555: Cobas U411 Test System

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Apr 2, 2010 after 136 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
Longest line of descent: 1 generation back to K921087 (1992). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921087: Chemstrip Urine Analyzer, Boehringer Mannheim Corp. (1992) Summary page 2.
- K931602: Chemstrip Urine Analyzer, Boehringer Mannheim Corp. (1993)

## Most influential descendants
- K183432: cobas u 601 urinalysis test system (2019), 0 descendants of its own

## Indications for use
The cobas 1141 1 urine analyzer is a semi-automated, benchtop analyzer which is designed to read the Chemstrip 10 UA (Combur' 0 Test M) test strips for urinalysis for the measurement of bilirubin, blood, glucose, ketone, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen and color (if selected). These measurements are useful in the evaluation of renal, urinary and metabolic disorders. Tests performed using the cobas u41 I are intended for prescription, in vitro diagnostic use only.

Source page: https://510kreport.com/device/K093555
Methodology: https://510kreport.com/methodology