# K082811: Uritest 10G & 11G Urine Reagent Strips and Uritest-50 and Uritest-500B Urine Analyzers

- Pathway: 510(k) (Traditional)
- Applicant: Urit Medical Electronic Co., Ltd.
- Decided: Sep 11, 2009 after 352 days
- Product code: JIO (Blood, Occult, Colorimetric, In Urine)
- Device class: 2
- Regulation: 21 CFR 864.6550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K861255 (1986). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K926359: Clinitek 200+ Urine Chemistry Analyzer, Heraeus Kulzer, Inc. (1993) Summary page 1.
- K052719: Uritest 10 Urinalysis Reagent Strips, Arj Medical, Inc. (2006) Summary page 1.
- K040703: Uristik H Series Reagent Strips for Urinalysis, Dirui Industrial Co., Ltd. (2004)

## Most influential descendants
- K232317: UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips (2024), 0 descendants of its own

## Indications for use
The Uritest-50 and Uritest-500B urine analyzers are semi-automated, bench top instruments which are intended for professional, in vitro diagnostic use only. Depending on the reagent strips being used, the instruments perform semi-quantitative detection of the following analytes in urine: leukocytes, ketone, nitrite, urobilinogen, bilirubin, protein, glucose, specific gravity, blood, pH and ascorbic acid (Uritest 10G urine reagent strips don't have the ascorbic acid pad). Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria. The instruments use the accompanying check strip for daily calibration. Uritest 10G urine reagent strips provide semi-quantitative tests for leukocytes, ketone, nitrite, urobilinogen, bilirubin, protein, glucose, specific gravity, blood and pH in urine. The Uritest 10G urine reagent strips are for use with the Uritest-50 urine analyzer and are for professional, in vitro diagnostic use only. Uritest 11 G urine reagent strips provide semi-quantitative tests for leukocytes, ketone, nitrite, urobilinogen, bilirubin, protein, glucose, specific gravity, blood, pH and ascorbic acid in urine. The Uritest 11 G urine reagent strips are for use with Uritest-500B urine analyzer and are for professional, in vitro diagnostic use only.

Source page: https://510kreport.com/device/K082811
Methodology: https://510kreport.com/methodology