# K040703: Uristik H Series Reagent Strips for Urinalysis

- Pathway: 510(k) (Traditional)
- Applicant: Dirui Industrial Co., Ltd.
- Decided: Aug 26, 2004 after 162 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: 1 generation back to K861255 (1986). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K861255: Behring Rapignost Total Screen L Urine Test Strips, Behring Diagnostics, Inc. (1986) Summary page 2.
- K896454: Chemstrip (R) 10 with SG Urine Test Strips, Boehringer Mannheim Corp. (1990) Summary page 2.
- K993850: Urinalysis Reagent Strips (10 Parameters), International Newtech Development, Inc. (2000) Summary page 2.
- (no number) Bayer Corporation MULTISTIX 10 SG Reagent Strips: named in the summary without a submission number

## Most influential descendants
- K082811: Uritest 10G & 11G Urine Reagent Strips and Uritest-50 and Uritest-500B Urine Analyzers (2009), 1 descendant of its own
- K232317: UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips (2024), 0 descendants of its own
- K111999: Healgen 11 Reagent Strip for Urinalysis, Healgen 10 Reagent Strip for Urinalysis, and Healgen 4 Reagent Strip for Urinal (2012), 0 descendants of its own

## Indications for use
URISTIK H Series Reagent Strips provide qualitative and semi-quantitative tests for ascorbic acid, pH, specific gravity, ketones (acetoacetic acid), blood, protein, nitrite, leukocytes, glucose, bilirubin, and urobilinogen in urine. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria. Dirui H Series Reagent Strips are for single use in professional near-patient screening (point-of-care) and centralized laboratory locations. The strips are intended for use in at-risk patients to assist diagnosis in the following areas: Kidney function Urinary tract infections Carbohydrate metabolism (e.g. diabetes mellitus) Liver function Acid-base balance Urine concentration Test results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed.

Source page: https://510kreport.com/device/K040703
Methodology: https://510kreport.com/methodology