# K232317: UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips

- Pathway: 510(k) (Traditional)
- Applicant: Urit Medical Electronic Co., Ltd.
- Decided: Apr 26, 2024 after 267 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: 5 generations back to K890577 (1989). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082811: Uritest 10G & 11G Urine Reagent Strips and Uritest-50 and Uritest-500B Urine Analyzers, Urit Medical Electronic Co., Ltd. (2009) Summary page 5.
- K142391: Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine ), ACON Laboratories, Inc. (2014) Summary page 5.
- K093098: Aution Max Model AX-4030 Urinalysis System, Arkray, Inc. (2009) Summary page 5.

## Indications for use
The UC-1800 Automatic Urine Analyzer is automated instrument which is 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: ascorbic acid, microalbumin, leukocytes, creatinine, ketone, urobilinogen, bilirubin, glucose, protein, specific gravity, blood and pH in urine and for qualitative determination of nitrite in urine. The urine hydrometer (optional) can determine the color and turbidity of urine. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria. The URIT 11FA urine reagent strips provide semi-quantitative tests for ascorbic acid, leukocytes, ketone, urobilinogen, bilirubin, glucose, protein, specific gravity, blood and pH in urine and for qualitative determination of nitrite in urine. The URIT 11FA urine reagent strips are for use with the UC-1800 Automatic Urine Analyzer and are for professional, in vitro diagnostic use only. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria. The URIT 12FA urine reagent strips provide semi-quantitative tests for microalbumin, leukocytes, creatinine, ketone, urobilinogen, bilirubin, glucose, protein, specific gravity, blood and pH in urine and for qualitative determination of nitrite in urine. The URIT 12FA urine reagent strips are for use with the UC-1800 Automatic Urine Analyzer and are for professional, in vitro diagnostic use only. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria.

Source page: https://510kreport.com/device/K232317
Methodology: https://510kreport.com/methodology