(30 days)
Wondfo Methadone Urine Test (MTD 200) is an immunochromatographic assay for the qualitative determination of Methadone in human urine at a Cut-Off concentration of 200 ng/mL. The test is available in a Dip Card format and a Cup format. This product is only intended for prescription use and is not intended for point-of-care use. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
Wondfo Morphine Urine Test (MOP 100) is an immunochromatographic assay for the qualitative determination of Morphine in human urine at a Cut-Off concentration of 100 ng/mL. The test is available in a Dip Card format and a Cup format. This product is only intended for prescription use and is not intended for point-of-care use. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
Immunochromatographic assays for Methadone and Morphine Urine Tests use a lateral flow, one step system for the qualitative detection of Methadone and Morphine (target analyte) in human urine. Each assay uses a monoclonal antibody-dye conjugate against drugs with gold chloride and fixed drug-protein conjugates and anti-mouse IgG polyclonal antibody in membranes.
Here's a summary of the acceptance criteria and study details for the Wondfo Methadone Urine Test (MTD200) and Wondfo Morphine Urine Test (MOP100), based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in a quantitative manner (e.g., "sensitivity must be >X%"). Instead, the precision study demonstrates performance at various concentrations relative to the cut-off, and the comparison study evaluates agreement with GC/MS. The implied acceptance criteria are that the device should accurately classify samples at and above the cut-off as positive, and samples below the cut-off as negative, with high consistency.
Wondfo Methadone Urine Test (MTD200)
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|---|
| Precision | Consistent results across multiple runs and lots. | Cup Format: At -100% to -25% cut-off, all 50 tests per lot were negative. At +25% to +100% cut-off, all 50 tests per lot were positive. At the cut-off, 45-46 out of 50 tests were positive (some variability within 3 lots). |
| Dip Card Format: Similar results, with 45-47 out of 50 tests positive at the cut-off. | ||
| Cut-off Verification | Accurate measurement at specified cut-off. | All samples at and above +25% Cut-off were positive. All samples at and below -25% Cut-off were negative. Verified cut-off for Methadone: 200 ng/mL. |
| Interference | No interference from common substances at specified concentrations. | Many common substances (listed in the document) showed no interference at 100 ug/mL when spiked into drug-free urine and urine with target drugs at ±25% cut-off. No differences between Dip Card and Cup formats. |
| Specificity (Cross-Reactivity) | Minimal cross-reactivity with structurally similar compounds. | Methadone: Doxylamine showed 0.5% cross-reactivity at 40,000 ng/mL (i.e., 40,000 ng/mL of Doxylamine produced a positive result, equivalent to 200 ng/mL Methadone). |
| Effect of Specific Gravity & pH | Stable performance across physiological ranges. | Results were all positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off, for urine specific gravity 1.000 |
| Method Comparison (vs. GC/MS) | High agreement with GC/MS, especially near the cut-off. | Cup Format (Viewer A, B, C): Out of 80 clinical samples (40 negative, 40 positive), no false positives in drug-free or low negative GC/MS samples. Few false negatives in "Near Cut-Off Negative" samples (e.g., Viewer A: 2 negatives out of 17 near cut-off negatives were called positive by Wondfo; meaning Wondfo correctly identified 15/17. Discordant results for Viewer A: MTD2061 (186 ng/mL) and MTD2063 (192 ng/mL) were positive by Wondfo but are below 200ng/mL cut-off by GC/MS, so these are false positives for a 200ng/mL cut-off. This is not explicitly highlighted as a failure criterion. |
| Dip Card Format (Viewer A, B, C): Similar pattern to Cup format. Discordant results also noted for samples just below the cut-off. |
Wondfo Morphine Urine Test (MOP100)
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|---|
| Precision | Consistent results across multiple runs and lots. | Cup Format: At -100% to -25% cut-off, all 50 tests per lot were negative. At +25% to +100% cut-off, all 50 tests per lot were positive. At the cut-off, 45-46 out of 50 tests were positive. |
| Dip Card Format: Similar results, with 45-49 out of 50 tests positive at the cut-off. | ||
| Cut-off Verification | Accurate measurement at specified cut-off. | All samples at and above +25% Cut-off were positive. All samples at and below -25% Cut-off were negative. Verified cut-off for Morphine: 100 ng/mL. |
| Interference | No interference from common substances at specified concentrations. | Many common substances (listed in the document) showed no interference at 100 ug/mL when spiked into drug-free urine and urine with target drugs at ±25% cut-off. No differences between Dip Card and Cup formats. |
| Specificity (Cross-Reactivity) | Minimal cross-reactivity with structurally similar compounds. | Morphine: |
- Codeine: 100% cross-reactivity (100 ng/mL)
- Ethylmorphine: 50% cross-reactivity (200 ng/mL)
- Hydrocodone: 25% cross-reactivity (400 ng/mL)
- Hydromorphine: 50% cross-reactivity (200 ng/mL)
- Levorphanol: 2.0% cross-reactivity (5000 ng/mL)
- σ-Monoacetylmorphine: 50% cross-reactivity (200 ng/mL)
- Morphine 3-β-D-glucuronide: 50% cross-reactivity (200 ng/mL)
- Norcodeine: 20% cross-reactivity (500 ng/mL)
- Normorphine: 2.0% cross-reactivity (5000 ng/mL)
- Oxycodone: 10% cross-reactivity (1000 ng/mL)
- Oxymorphine: 10% cross-reactivity (1000 ng/mL)
- Procaine:
§ 862.3620 Methadone test system.
(a)
Identification. A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.(b)
Classification. Class II (special controls). A methadone test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).