URS-2GP Urine Strips (Glucose Protein)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K131600 FDA 510(k)
- FDA Product Code
- JIL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1340 FDA 510(k)
- Regulation Number
- 862.1340 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The URS-2GP Urine Strips are semi-quantitative, visually read reagent strips designed for the qualitative detection of glucose and protein in urine. Classified as an enzymatic, non-quantitative method for urinary analysis, these strips provide rapid, point-of-care results to assess carbohydrate metabolism and kidney function.
These single-use, non-sterile strips are supplied in bottles of 100 and are intended for manual use in clinical chemistry settings. They are not MRI-compatible and require comparison against a color chart on the bottle for interpretation. Regulated under FDA 510(k) clearance (K131600), they fall under device class II and are intended for prescription use.
Frequently asked questions
What are the URS-2GP urine strips used for?
The URS-2GP urine strips are designed for the qualitative detection of glucose and protein in urine. They use an enzymatic method to assess carbohydrate metabolism (e.g., diabetes monitoring) and kidney function (e.g., proteinuria screening). Results are semi-quantitative and visually interpreted against the included color chart, making them ideal for point-of-care clinical chemistry testing.
How are the URS-2GP urine strips supplied, and what is their sterility status?
These strips are supplied in bottles containing 100 single-use units. They are non-sterile, meaning they are not intended for invasive procedures or sterile environments. The packaging ensures stability for manual clinical use but does not guarantee sterility beyond the manufacturer’s specifications.
Are these strips reusable, and how should they be stored?
The URS-2GP urine strips are strictly single-use only. For proper storage, keep the bottle tightly sealed in a cool, dry place away from direct sunlight or extreme temperatures. Avoid exposure to moisture or contaminants, as this could compromise test accuracy. Check the expiration date on the bottle before use.
How do I interpret the results from these urine strips?
Results are determined by comparing the color change on the strip to the color chart provided on the bottle. The enzymatic reaction produces a visible hue proportional to the concentration of glucose or protein in the urine sample. For precise interpretation, ensure the strip is fully immersed in urine for the recommended duration (typically 1–2 minutes) and avoid reading after the specified time.
What regulatory approvals apply to the URS-2GP urine strips?
These strips are cleared by the FDA under the 510(k) pathway (K131600) and fall under device class II. They are intended for prescription use only and comply with regulatory standards for enzymatic, non-quantitative urinary glucose and protein detection. The clearance confirms they meet performance requirements for clinical chemistry applications.
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: Urinalysis - Teco Diagnostics, URS-2GP (GLUCOSE PROTEIN) URINE STRIPS - Innolitics, Urine Reagent Strip 2P - Teco Diagnostics, Teco URS-2P Protein-Glucose Reagent Strips | 100 Strips/Bottle
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K131600 | Class II | Active |
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Manufacturer
- Manufacturer
- Teco Diagnostics
Sources (1)
- FDA 510(k) K131600 24 fields · synced Oct 1, 2026