Fentanyl Urine Test Cassette – OTC (20 Tests/Kit)
$99.00
FDA 510(k) Cleared
20 tests per kit
$4.95 per test
Over-the-counter urine test cassette for the qualitative detection of fentanyl at a cutoff concentration of 1 ng/mL. Preliminary results are available in 5 minutes.
- FDA 510(k) cleared under K233417
- Uses three drops of collected urine
- Easy visual result interpretation
- Individually sealed, single-use test cassettes
| 1-5 | 6-10 | 11+ |
| $99.00 | $91.08 | $86.13 |
Fentanyl Urine Test Cassette Overview
The AllTest Fentanyl Urine Test Cassette is an over-the-counter lateral-flow immunoassay for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1 ng/mL. The test is simple to perform and provides preliminary results in 5 minutes. Each kit contains 20 single-use tests.
FDA 510(k) Cleared
1 ng/mL Cutoff
20 Tests per Kit
Features and Benefits
Cleared for over-the-counter use
FDA 510(k) cleared under K233417
Detects fentanyl at a 1 ng/mL cutoff
Preliminary results in 5 minutes
Requires only three drops of urine
Easy visual result interpretation
DFY-A102H
DTK-108103
20 tests per kit
This test provides only a qualitative, preliminary result. A presumptive positive result should be confirmed using a more specific laboratory method. GC/MS or LC/MS is the preferred confirmatory method.
Fentanyl Cutoff and Detection Window
| Detectable Drug | Abbreviation | Cutoff | Estimated Detection Window |
|---|---|---|---|
| Fentanyl | FYL | 1 ng/mL | 1–3 days |
Detection windows are general estimates and can vary based on frequency and duration of use, the amount consumed, individual metabolism and other biological factors. Always follow the package insert when performing and interpreting the test.
How to Perform the Test
- Allow the test to reach room temperature and wash your hands thoroughly.
- Collect the urine specimen in a clean, dry container.
- Open the foil pouch and remove the test cassette and dropper.
- Place the cassette on a clean, level surface.
- Hold the dropper vertically and add three full drops of urine to the specimen well marked “S.”
- Start the timer and read the results at 5 minutes.
- Do not interpret the result after 10 minutes.
Understanding the Results
Negative: Two colored lines appear—one next to “C” and one next to “T.” A faint test line should still be interpreted as negative.
Preliminary positive: One colored line appears next to “C,” with no line next to “T.” Laboratory confirmation is required.
Invalid: No control line appears. Repeat the procedure using a new test cassette.
Storage and Handling
Store the test in its sealed pouch at 35.6–86°F (2–30°C), away from direct sunlight, moisture and heat. Do not freeze. Do not use the test after the expiration date or if the foil pouch is damaged.
Instructions and Regulatory Documents
Frequently Asked Questions
Is this fentanyl urine test available over the counter?
Yes. The AllTest Fentanyl Urine Test Cassette is FDA 510(k) cleared for over-the-counter use.
What is the fentanyl cutoff concentration?
The test detects fentanyl in human urine at a cutoff concentration of 1 ng/mL.
How quickly are results available?
Read the test result at 5 minutes. Do not interpret the result after 10 minutes.
Does a positive result confirm fentanyl use?
No. The cassette provides only a preliminary screening result. A presumptive positive result should be confirmed by a laboratory using GC/MS or LC/MS.
What does a faint test line mean?
Any visible line next to the “T,” even a faint line, should be interpreted as negative when the control line is also present.
How many tests are included?
Each kit contains 20 single-use fentanyl urine test cassettes.
Looking for fentanyl information?
Review information about fentanyl, its effects and related safety concerns from the U.S. Drug Enforcement Administration.
Additional information
| Weight | 6 lbs |
|---|---|
| Dimensions | 15 × 15 × 4.5 in |
