Search Results
Found 1 results
510(k) Data Aggregation
(28 days)
WONDOFO MULTI-DRUG URINE TEST CUP / PANEL
Wondfo Multi-Drug Urine Test Cup and Wondfo Multi-Drug Urine Test Panel are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, o Oxazepam, Cocaine, Cocaine, Connelinoids, Contraliae, Methylenedioxymethamphetamine, Morphine, Morphine 2000, Phencyclidine, Oxycodone and Buprenorphine in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
|---|---|
| Amphetamine(AMP) | 1000 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300 ng/mL |
| Cannabinoids (THC) | 50 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP) | 300 ng/mL |
| Morphine 2000 (OPI) | 2000 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
Configuration of the Wondfo Multi-Drug Urine Test Cup and Wondfo Multi-Drug Urine Test Panel can consist of any combination of the above listed drug analytes.
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.
The test will yield preliminary positive results when prescription drugs Buprenorphine, Oxazepam, Oxycodone and Secobarbital are ingested, even at or above therapeutic doses. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
Wondfo Multi-Drug Urine Test Cup and Wondfo Multi-Drug Urine Test Panel are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Oxazepam, Amphetamine, Secobarbital, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine 2000, Phencyclidine, Oxycodone and Buprenorphine in human urine samples. Wondfo Multi-Drug devices detect each of analytes on different strips.
A positive urine sample will not generate a colored-line for the specific drug tested in the designated region. A negative urine specimen or a urine sample containine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methylenedioxymethamphetamine, Morphine, Morphine, Morphine 2000, Phencyclidine, Oxycodone and Buprenorphine at the concentration below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a test control, a color line will always appear at the control region.
The document describes the Wondfo Multi-Drug Urine Test Cup and Panel, which are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of various drugs in human urine. The acceptance criteria and study details are extracted below.
1. Table of Acceptance Criteria and Reported Device Performance:
The document implicitly defines the acceptance criteria as the detection of the specified drugs at or above defined cut-off levels. The "reported device performance" is not presented in a formal table with specific metrics like sensitivity, specificity, or accuracy compared to a gold standard. Instead, the document states that the device is "substantially equivalent" to legally marketed predicate devices, implying that its performance meets the established standards for such devices. The document does not provide a direct performance study comparing the device against a confirmed ground truth with quantitative metrics for true positives, true negatives, false positives, and false negatives.
| Drug (Identifier) | Cut-off level (Acceptance Criteria) | Reported Device Performance (Implicitly meets predicate device performance) |
|---|---|---|
| Amphetamine (AMP) | 1000 ng/mL | Qualitatively detects at or above cut-off |
| Secobarbital (BAR) | 300 ng/mL | Qualitatively detects at or above cut-off |
| Oxazepam (BZO) | 300 ng/mL | Qualitatively detects at or above cut-off |
| Cocaine (COC) | 300 ng/mL | Qualitatively detects at or above cut-off |
| Cannabinoids (THC) | 50 ng/mL | Qualitatively detects at or above cut-off |
| Methamphetamine (MET) | 1000 ng/mL | Qualitatively detects at or above cut-off |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL | Qualitatively detects at or above cut-off |
| Morphine (MOP) | 300 ng/mL | Qualitatively detects at or above cut-off |
| Morphine 2000 (OPI) | 2000 ng/mL | Qualitatively detects at or above cut-off |
| Phencyclidine (PCP) | 25 ng/mL | Qualitatively detects at or above cut-off |
| Oxycodone (OXY) | 100 ng/mL | Qualitatively detects at or above cut-off |
| Buprenorphine (BUP) | 10 ng/mL | Qualitatively detects at or above cut-off |
2. Sample Size and Data Provenance for the Test Set:
The provided document does not contain information regarding the specific sample size used for a test set or the data provenance (e.g., country of origin, retrospective or prospective) for any performance study. The submission is a 510(k) summary demonstrating substantial equivalence, not a detailed clinical study report.
3. Number of Experts and Qualifications for Ground Truth:
The document does not provide information regarding the number of experts used to establish a ground truth or their qualifications. The device is for in-vitro diagnostics, and for such devices, ground truth is typically established by laboratory reference methods.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method as no specific test set or human interpretation of results is detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is mentioned or referenced in the provided document. This device is an in-vitro diagnostic test, not a medical imaging or interpretation aid where human reader performance would be a primary metric.
6. Standalone (Algorithm Only) Performance Study:
The document does not detail a "standalone" algorithmic performance study in the context of AI. The device itself is a standalone immunoassay. The information provided is a description of the device and its intended use, along with a comparison to predicate devices, to establish substantial equivalence. Implicitly, the performance referred to is the device's ability to qualitatively detect drugs at the specified cut-off levels.
7. Type of Ground Truth Used:
While not explicitly stated within the provided text, for in-vitro diagnostic devices like drug test cups, the "ground truth" for demonstrating performance is typically established by confirmatory analytical methods such as Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS). The document mentions this: "A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method." This indicates that these methods would be used to verify the presence and concentration of drugs in urine samples to establish ground truth for testing the immunoassay's accuracy.
8. Sample Size for the Training Set:
The document does not provide information regarding the sample size used for any training set. This is a descriptive document for regulatory submission, not a machine learning development report.
9. How the Ground Truth for the Training Set Was Established:
The document does not provide information regarding how ground truth for a training set was established. Given the nature of a lateral flow immunoassay, a "training set" in the machine learning sense is not typically applicable for its development or validation process as described in this type of regulatory submission. The device's performance relies on established chemical and immunological principles, not on learning from a data set.
Ask a specific question about this device
Page 1 of 1