# K012397: Urisys 2400 Urine Test Strip

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Sep 26, 2001 after 61 days
- Product code: JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative))
- Device class: 2
- Regulation: 21 CFR 862.1340
- 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: 1 generation back to K934042 (1993). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934042: Chemstrip Super UA Urine Analyzer, Boehringer Mannheim Corp. (1993) Summary page 2.

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

## Recalls of this device
- Jul 15, 2016 · Class II · Z-0099-2017: Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarif

## Indications for use
For semi-quantitative determination of pH, leukocytes, nitrite, protein, glucose, ketone bodies, urobilinogen, bilirubin and blood in urine by reflectance photometry with the Urisys 2400 photometer.

Source page: https://510kreport.com/device/K012397
Methodology: https://510kreport.com/methodology