Product Specifications
| Specification | Details |
| Manufacturer / Brand | Wondfo USA Co., Ltd. / SAFElife™ C-Cup® (Compact) |
| Manufacturer # / SKU | CDOA-9125A3E3F |
| CLIA / Regulatory Status | Forensic Use Only (FUO) |
| Sample Type | Human Urine |
| Read Time | 5 Minutes |
| Accuracy Rate | Up to 99% agreement with reference methods |
| Panels Tested (12 Drugs) | AMP, BUP, BZO, COC, ETG, FTY, mAMP, MDMA, MOP/OPI, MTD, OXY, THC |
| Adulterant Testing (SVT) | Creatinine (CR), pH, Specific Gravity (SG) |
| 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 |
| Buprenorphine | BUP | 10 ng/mL |
| Benzodiazepines | BZO | 300 ng/mL |
| Cocaine | COC | 300 ng/mL |
| Ethyl Glucuronide (Alcohol) | ETG | 300 ng/mL or 500 ng/mL |
| Fentanyl | FTY / FYL | 20 ng/mL |
| Methamphetamine | mAMP / MET | 1,000 ng/mL |
| Ecstasy | MDMA | 500 ng/mL |
| Opiates / Morphine | MOP / OPI | 300 ng/mL |
| Methadone | MTD | 300 ng/mL |
| Oxycodone | OXY | 100 ng/mL |
| Marijuana | THC | 50 ng/mL |
Key Features & Clinical Applications
-
Comprehensive 12-Panel Detection: Combines standard drugs of abuse with specialty screening targets—including Fentanyl (FTY) and the extended alcohol metabolite Ethyl Glucuronide (ETG)—in a single testing cup.
-
Integrated Specimen Validity Testing (SVT): Features a built-in 3-pad adulteration strip checking Creatinine, pH, and Specific Gravity to detect synthetic urine or dilution attempts.
-
Temperature Verification: Equipped with a rapid-reacting thermal strip on the exterior wall to confirm fresh specimen collection ($90^\circ\text{F}$ to $100^\circ\text{F}$) within 4 minutes.
-
Compact Low-Volume Well: The specialized “C-Cup” design allows test strips to run efficiently even when smaller urine sample volumes are provided.
-
Rapid Visual Interpretation: Clear visual bands appear within 5 minutes, allowing fast, qualitative screening decisions.
⚠️ 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.
⚠️ Regulatory Classification: Classified for Forensic Use Only (FUO). Not intended for diagnostic clinical decision-making or medical diagnostic use in hospital settings without confirmatory testing.
⚠️ Result Time Limit: Read test results strictly at 5 minutes. Do not interpret visual test strip control or test lines after 10 minutes, as false readings may occur.
