Product Specifications
| Specification | Details |
| Manufacturer / Brand | Wondfo USA Co., Ltd. / SAFElife™ T-Cup® |
| Manufacturer # / SKU | TDOA-254A3 |
| CLIA / Regulatory Status | CLIA Waived / FDA 510(k) Cleared |
| Sample Type | Human Urine |
| Read Time | 5 Minutes |
| Accuracy Rate | Up to 99% agreement with reference GC/MS methods |
| Panels Tested (5 Drugs) | AMP, COC, mAMP/MET, OPI, THC |
| Adulterant Testing (SVT) | Creatinine (CR), Specific Gravity (SG), pH |
| Temperature Strip | Integrated (90°F to 100°F / 32°C to 38°C) |
| Storage Temperature | 2°C to 30°C (36°F to 86°F) (Do not freeze) |
| Packaging Configuration | 25 Test Cups per Box |
| Latex / Sterility | Non-Sterile / Diagnostic Device |
Panel Configuration & Cutoff Levels
| Drug / Assay | Abbreviation | Cutoff Level |
| Amphetamine | AMP | 1,000 ng/mL |
| Cocaine | COC | 300 ng/mL |
| Methamphetamine | mAMP / MET | 1,000 ng/mL |
| Opiates | OPI | 2,000 ng/mL |
| Marijuana | THC | 50 ng/mL |
Key Features & Clinical Applications
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All-in-One Self-Contained Cup: Eliminates direct urine handling, dipping, and pipette transfers. Specimen is collected directly in the cup and visual results activate automatically upon contact.
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Core 5-Panel SAMHSA Screening: Focuses on the primary five illicit drug classes (AMP, COC, mAMP, OPI, THC), making it ideal for standard pre-employment, criminal justice, and clinical monitoring protocols.
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Integrated Specimen Validity Testing (SVT): Features built-in adulteration strips checking Creatinine, Specific Gravity, and pH directly inside the cup to immediately catch synthetic, diluted, or adulterated samples.
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Built-in Temperature Strip: Includes a rapid-reacting thermal strip on the exterior cup wall to verify fresh specimen collection ($90^\circ\text{F}$ to $100^\circ\text{F}$) within 4 minutes.
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CLIA Waived & FDA Cleared: Fully cleared for use across CLIA-waived medical practices, urgent care centers, occupational health clinics, and point-of-care settings.
⚠️ Preliminary Screening Notice: This rapid assay provides qualitative preliminary analytical test results only. A more specific alternative chemical method—such as Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) or Gas Chromatography-Mass Spectrometry (GC-MS)—must be used to obtain a confirmed quantitative analytical result.
⚠️ Leak-Prevention Notice: Ensure the cap is screwed on tightly until sealed to prevent leaking during handling or laboratory transport for confirmation testing.
⚠️ Result Time Limit: Read test and adulteration results strictly at 5 minutes. Do not interpret visual test strip lines after 10 minutes, as color intensity may alter over time.
