# K033548: Roche Diagnostics Urisys 1100 Urine Analyzer

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Nov 24, 2003 after 12 days
- Product code: KHE (Reagent, Occult Blood)
- Device class: 2
- Regulation: 21 CFR 864.6550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K943592 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983510: Chemstrip 101 Urine Analyzer, Boehringer Mannheim Corp. (1998) Summary page 1.

## Recalls of this device
- Sep 24, 2018 · Class II · Z-0301-2019: Limits of Detection (LoD) for protein, nitrite, leukocytes, and erythrocytes on the Urisys 1100 urine analyzer with Chemstrip 5 OB, Chemstrip 7, Chemstrip 10 MD, and Chemstrip 10 UA test strips were h

## Indications for use
The Urisys 1100 Urine Analyzer is a reflectance photometer designed to automatically read and evaluate the results of Chemstrip 5 OB, Chemstrip 7 and Chemstrip 10 MD urine test strips for various urine analytes: specific gravity, pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin and blood.

Source page: https://510kreport.com/device/K033548
Methodology: https://510kreport.com/methodology