Uristik H Series Reagent Strips for Urinalysis
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K040703 FDA 510(k)
- FDA Product Code
- JIO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.6550 FDA 510(k)
- Regulation Number
- 864.6550 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Uristik H Series Reagent Strips for Urinalysis are dry reagent strips designed for qualitative and semi-quantitative urinalysis. These firm plastic strips are impregnated with multiple chemical reagents to detect and measure various urine constituents, including urobilinogen, bilirubin, ketone, blood, protein, nitrite, leukocytes, glucose, specific gravity, pH, and ascorbic acid. They function by changing color when exposed to specific analytes in urine, enabling visual or instrumental analysis.
These strips are intended for single-use in clinical settings and are supplied in sterile packaging. They are compatible with Dirui’s H-50, H-100, and H-500 Urine Analyzers for instrumental reading or can be read visually against a color chart. The device holds FDA 510(k) clearance (K040703) and IVDD authorization, adhering to regulatory standards for in vitro diagnostic devices. Storage conditions and expiration dates are specified on the packaging to maintain reagent integrity.
Frequently asked questions
Are these reagent strips designed for repeated use in clinical settings, or are they intended for single-use only?
The Uristik H Series reagent strips are explicitly designed for single-use in clinical settings. This is confirmed by their packaging being described as sterile, which is a standard requirement for single-use diagnostic devices to prevent cross-contamination and ensure reagent integrity.
What specific urine constituents can these strips detect, and how do they work?
The Uristik H Series detects and measures urobilinogen, bilirubin, ketone, blood, protein, nitrite, leukocytes, glucose, specific gravity, pH, and ascorbic acid through colorimetric reactions. Each reagent on the strip changes color when exposed to specific analytes in urine, allowing for qualitative or semi-quantitative analysis—either visually against a color chart or instrumentally using Dirui’s H-50, H-100, or H-500 analyzers.
How should these reagent strips be stored, and what happens if they’re exposed to improper conditions?
Storage conditions and expiration dates are clearly marked on the packaging to maintain reagent integrity. While the exact details aren’t specified, typical dry reagent strips like these require protection from moisture, extreme temperatures, and light. Exposure to improper conditions could degrade the reagents, leading to inaccurate test results or invalid readings.
Can these strips be used with any urinalysis analyzer, or are they compatible only with Dirui’s systems?
The Uristik H Series is compatible only with Dirui’s H-50, H-100, and H-500 Urine Analyzers for instrumental reading. While they can also be read visually against a color chart, they are specifically designed to integrate with Dirui’s analyzers for automated, precise measurements.
What regulatory pathways have these strips undergone, and what does that mean for their use in clinical settings?
The Uristik H Series holds FDA 510(k) clearance (K040703) and IVDD authorization, meaning it meets U.S. and European regulatory standards for in vitro diagnostic devices. This clearance indicates the device has been deemed substantially equivalent to a predicate device and adheres to safety and performance requirements, ensuring reliability for clinical use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Uristik H Series Reagent Strips for Urinalysis, Uristik H Series Reagent Strips for Urinalysis, PDF 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY DEVICE ..., Uristik H10 Strip Urine Automatic (100 tests) -Biolab Diagnostics
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K040703 | Class II | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- FDA Applicant
- Dirui Industrial Co., Ltd.
Sources (2)
- FDA 510(k) K040703 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026