Professional Drug Test Cup Medical Diagnostic Kit FDA 510K Approval
Integrated Split Cup of Multi Drug Abuse Testing with Key to Control Test
Direction for use
SPECIMEN COLLECTION AND PREPARATION
WHEN TO COLLECT URINE FOR THE TEST?
The minimum detection time is 2-7 hours, so you may collect urine samples 2-7 hours after suspected drug use.
HOW TO COLLECT URINE?
1. Urinate directly into the provided urine cup.
2. Open the Labeled Vial and carefully pour the urine specimens from the urine cup into the Labeled Vial. Fill the vial to about two thirds (2/3) full and tightly close the cap. This Labeled Vial urine sample is for shipping to the laboratory for confirmation testing. Make sure that the number on the Labeled Vial matches your personal Identification Number.
3. The residual urine sample in the urine cup is for your self-testing.
Specimen Storage
Urine specimens may be stored at 2-8°C for up to 48 hours prior to testing. For prolonged storage, specimens may be frozen and stored below -20°C. Frozen specimens should be thawed and mixed well before testing.
Note: Allow the test cup to come to room temperature [15-30℃ (59-86℉)] prior to test.
1. Bring the pouch to room temperature before opening it. Remove the cup from the sealed pouch and use it as soon as possible.
2. Remove the key by twisting it from the center of the cup cap.
3. Collect specimen in the cup and secure cap tightly by pressing down on the pull tab until an audible click is heard.
4. Technician dates and initials the security seal and attaches the security seal over the cup cap.
5. Place the cup on a flat surface and push the key to a fully closed position to initiate the test. Start the timer.
6. Remove the peel off label covering the test results.
7. If adulteration is included on the test cup, read the adulteration strip(s) between 3 and 5 minutes. Compare the colors on the adulteration strip to the enclosed color chart. If the specimen indicates adulteration, refer to your Drug Free Policy for
guidelines on adulterated specimens. We recommend not to interpret the drug test results and either retest the urine or collect another specimen.
8. Read the drug strip results at 5 minutes. The drug test results remain stable for up to ONE HOUR.
| Test | Calibrator | Cut-off (ng/mL) |
| Methamphetamine (MET, mAMP ) | D-Methamphetamine | 1,000 |
| Methamphetamine (MET, mAMP ) | D-Methamphetamine | 500 |
| Cocaine(COC ) | Benzoylecgonine | 300 |
| Cocaine(COC ) | Benzoylecgonine | 150 |
| Marijuana (THC ) | 11-nor-Δ9-THC-9 COOH | 50 |
| Morphine (MOP ) | Morphine | 2,000 |
| Morphine (MOP ) | Morphine | 300 |
| Benzodiazepines (BZO) | Oxazepam | 300 |
| MDMA(Ecstasy) | D,L- Methylenedioxy-methamphetamine | 500 |
| Oxycodone (OXY ) | Oxycodone | 100 |
| Barbiturates (BAR) | Secobarbital | 300 |
| Buprenorphine (BUP) | Buprenorphine | 10 |
| Methadone (MTD) | Methadone | 300 |
| Phencyclidine (PCP) | Phencyclidine | 25 |
| Amphetamine (AMP) | D-Amphetamine | 1,000 |
| Amphetamine (AMP) | D-Amphetamine | 500 |
| EDDP (Methadone Metabolites) | 2-Ethylidene-1,5-dimethyl-3,3-dipheylpyrrolidine (EDDP) | 300 |
| Tricyclic Antidepressants (TCA) | Nortriptyline | 1,000 |
| Propoxyphene (PPX) | Propoxyphene | 300 |
This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
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