Accutest URS 11 Parameter Urine Reagent Strips-100 Strips/Bottle
$18.50
FDA 510(k) Cleared
Professional Use
100 Strips per Bottle
100 strips per bottle • $0.19 per strip
Accutest® URS-11 Urine Reagent Strips provide qualitative and semi-quantitative visual urinalysis for glucose, bilirubin, ketone, specific gravity, ascorbic acid, blood, pH, protein, urobilinogen, nitrite and leukocytes in human urine. This professional-use configuration is CLIA waived when read visually.
- 11 urinalysis parameters on one single-use strip
- Includes an ascorbic-acid reagent area
- Qualitative results read between 1 and 2 minutes
- Semi-quantitative results compared with the bottle color chart at the specified times
- 100 strips per bottle
Call for bulk pricing: 866-205-9215
Accutest URS-11 Urine Reagent Strips Overview
Accutest® URS-11 Urine Reagent Strips are in vitro diagnostic test devices for qualitative and semi-quantitative urinalysis. Eleven reagent areas on each strip screen human urine for glucose, bilirubin, ketone, specific gravity, ascorbic acid, blood, pH, protein, urobilinogen, nitrite and leukocytes.
The strips are intended for single use in professional near-patient facilities and centralized laboratory settings. Results may be used with other diagnostic information when evaluating conditions that may involve diabetes, metabolic abnormalities, liver disease, kidney function or urinary tract infection. The product provides preliminary screening information and does not replace confirmatory testing or clinical evaluation.
FDA 510(k) Cleared
Professional Use
11 Parameters
Features and Benefits
Screens 11 urinalysis parameters on one reagent strip
Includes a dedicated reagent area for ascorbic acid
Provides qualitative and semi-quantitative visual results
Qualitative results are read between 1 and 2 minutes
Color blocks on the bottle label support direct visual comparison
CLIA waived when the strips are read visually
No analyzer or separate reagent preparation is required for visual use
100 single-use strips supplied per bottle
Product Details
UA711
DTK-109211
100 Strips
CR230297 / K111999
Technical Specifications
| Specification | Details |
|---|---|
| Test method | Visual color-comparison urine reagent strip |
| Result type | Qualitative and semi-quantitative |
| Parameters | Glucose, bilirubin, ketone, specific gravity, ascorbic acid, blood, pH, protein, urobilinogen, nitrite and leukocytes |
| Specimen | Fresh, well-mixed human urine collected in a clean, dry container |
| Qualitative read time | Between 1 and 2 minutes |
| Semi-quantitative read time | Read each reagent area at the time specified on the bottle color chart |
| Regulatory status | FDA 510(k) cleared; CLIA waived when read visually |
| Intended user | Professional in vitro diagnostic use only; not an over-the-counter self-test |
| Storage | 36-86°F (2-30°C) in the original bottle; keep dry and protect from heat and light; do not refrigerate |
| Opened-bottle stability | Up to 3 months after opening when stored below 65% relative humidity, without exceeding the labeled expiration date |
| Package size | 100 single-use strips per bottle |
11 Urinalysis Parameters
| Parameter | Reportable Range from the Package Insert |
|---|---|
| Glucose | Negative to 2,000 mg/dL |
| Bilirubin | Negative to 6 mg/dL |
| Ketone | Negative to 160 mg/dL |
| Specific gravity | 1.000 to 1.030 |
| Ascorbic acid | 0 to 100 mg/dL |
| Blood | Negative to 200 cells/µL |
| pH | 5.0 to 8.5 |
| Protein | Negative to 2,000 mg/dL |
| Urobilinogen | 0.2 to 8 mg/dL |
| Nitrite | Negative or positive |
| Leukocytes | Negative to 500 cells/µL |
Reportable ranges describe the color-chart values available for this test system; they are not diagnostic thresholds. Interpret every result according to the current bottle label and package insert and in the context of other clinical information.
How to Perform the Test
Collect fresh urine: Use a clean, dry container, mix the specimen and test it within 2 hours of collection.
Remove one strip: Take out only the strip needed for immediate testing and replace the bottle cap tightly.
Immerse and remove: Completely immerse all reagent areas in the urine, then remove the strip immediately.
Remove excess urine: Run the strip edge against the specimen-container rim, then hold the strip horizontally or place it on a flat surface.
Compare the colors: Match each reagent area with the corresponding color block on the bottle label at the specified time.
This procedure summary does not replace the package insert or bottle color chart. The insert permits pH and protein to be read immediately or up to 60 seconds after dipping, directs qualitative results to be read between 1 and 2 minutes and states that color changes after 2 minutes have no diagnostic value.
About the Ascorbic-Acid Parameter
The URS-11 configuration includes a reagent area that detects ascorbic acid in urine. The manufacturer explains that the ascorbic-acid result can provide information about a factor that may affect the glucose, bilirubin, blood and nitrite reactions. Follow the bottle color chart and the package insert when interpreting this reagent area.
Important Result and Testing Information
- This product provides preliminary qualitative and semi-quantitative urinalysis results; abnormal findings require appropriate clinical evaluation and confirmation when indicated.
- Test performance and visual interpretation can be affected by specimen composition, specific gravity, pH, lighting, color perception and interfering substances.
- Each color block represents a range of values, so a specimen near the boundary between two nominal levels may be reported at either level.
- Use fresh urine. Water must not be used as a negative control, and preservatives do not prevent deterioration of ketone, bilirubin or urobilinogen.
- Do not touch the reagent areas and do not use strips with discolored test pads.
- Follow applicable laboratory quality-control requirements and the complete instructions supplied with the product.
Storage and Handling
Store in the original bottle at 36-86°F (2-30°C)
Keep the strips dry and protect them from ambient moisture, light and heat
Do not refrigerate
Replace the bottle cap tightly immediately after removing a strip
After opening, the remaining strips are stable for up to 3 months when humidity is below 65% RH
Never use a strip after the expiration date printed on the product
Instructions and Product Documents
Frequently Asked Questions
What does the Accutest URS-11 strip measure?
Each strip screens urine for glucose, bilirubin, ketone, specific gravity, ascorbic acid, blood, pH, protein, urobilinogen, nitrite and leukocytes.
Is the Accutest URS-11 test CLIA waived?
Yes, when read visually. The manufacturer identifies the Accutest URS-11 strips as CLIA waived when read visually.
Is this an over-the-counter home test?
No. The package insert identifies the strips for professional use only, and the FDA 510(k) record identifies prescription use rather than over-the-counter use.
How quickly are results available?
For a qualitative result, the package insert directs users to read the reagent areas between 1 and 2 minutes. For semi-quantitative results, read each reagent area at the time specified on the bottle color chart. Do not interpret color changes that occur after 2 minutes.
Does the test require an analyzer?
No analyzer is required for visual interpretation. Compare the reagent areas directly with the corresponding color blocks on the bottle label and follow the package insert.
What is the difference between URS-11 and URS-10?
The URS-11 configuration includes all 10 parameters found on URS-10 plus an ascorbic-acid reagent area. UA711 is the 100-strip URS-11 bottle; UA710B is the separate 100-strip URS-10 configuration.
How long are the strips stable after opening?
The package insert states that the remaining strips are stable for up to 3 months after the bottle is opened when stored at less than 65% relative humidity. Keep the cap tightly closed and never use strips after the labeled expiration date.
What is included?
This configuration contains 100 single-use Accutest URS-11 reagent strips in one bottle. A urine specimen container and quality-control materials are not listed as included.
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Additional information
| Weight | 1 lbs |
|---|---|
| Dimensions | 2 × 6 × 2 in |
