(55 days)
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 Methamphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Amphetamine, Phencyclidine, Notriptyline and Methadone, Methylenedioxymethamphetamine, Morphine, Oxycodone 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 |
| Methadone (MTD) | 300 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Notriptyline (TCA) | 1000 ng/mL |
| Oxycodone (OXY) | 100 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 or LC/MS is the preferred confirmatory method.
The test will yield preliminary positive results when prescription drugs Notriptyline, 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 Methamphetamine, Cannabinoids, Oxazepam, Cocaine, Amphetamine, Secobarbital, Notriptyline and Methadone, Phencyclidine, Methylenedioxymethamphetamine, Morphine, Oxycodone 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 designation of third. Creating region. A negative urine specimen or a urine sample containing Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Phencyclidine, Notriptyline and Oxycodone below the cutoff levels will produce a colored line in the test region for the drug. To serve as a test control, a color line will always appear at the control region.
The provided text describes an in vitro diagnostic device (Wondfo Multi-Drug Urine Test Cup and Panel) for drug screening. As such, the typical acceptance criteria and study designs associated with AI/ML-driven medical devices (e.g., performance metrics like sensitivity/specificity, sample sizes for test sets, expert ground truth, MRMC studies) are not applicable.
This device is a qualitative immunoassay for the simultaneous detection of various drugs in human urine. The "acceptance criteria" here refer to the device's ability to accurately detect the presence or absence of specific drugs at defined cutoff concentrations. The "study" would involve testing the device's performance against known positive and negative urine samples.
Based on the provided document, here's a breakdown of the requested information, adapted for this type of device:
Acceptance Criteria and Device Performance for Wondfo Multi-Drug Urine Test Cup and Panel
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this type of device are primarily based on its ability to correctly identify positive and negative samples relative to established cutoff concentrations. While a detailed performance table from a specific study is not provided in the summary, the "Intended Use" section defines the critical cutoff levels for each drug. The "Description of the device" further details the expected visual results for positive and negative samples, which form the basis of performance evaluation during validation.
| Drug (Identifier) | Cut-off Level (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Amphetamine (AMP) | 1000 ng/mL | (Not specified in document) |
| Secobarbital (BAR) | 300 ng/mL | (Not specified in document) |
| Oxazepam (BZO) | 300 ng/mL | (Not specified in document) |
| Cocaine (COC) | 300 ng/mL | (Not specified in document) |
| Cannabinoids (THC) | 50 ng/mL | (Not specified in document) |
| Methamphetamine (MET) | 1000 ng/mL | (Not specified in document) |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL | (Not specified in document) |
| Morphine (MOP) | 300 ng/mL | (Not specified in document) |
| Methadone (MTD) | 300 ng/mL | (Not specified in document) |
| Phencyclidine (PCP) | 25 ng/mL | (Not specified in document) |
| Notriptyline (TCA) | 1000 ng/mL | (Not specified in document) |
| Oxycodone (OXY) | 100 ng/mL | (Not specified in document) |
Note: The document states "Wondfo Multi-Drug devices detect each of analytes on different strips" and describes how positive/negative samples are indicated visually. The regulatory submission implies that the device successfully meets performance requirements for detecting these substances at the specified cut-off levels, but the specific performance metrics (e.g., sensitivity, specificity, accuracy, precision data) from the validation studies are not included in this summary. These would typically be found in the full 510(k) submission.
2. Sample Size Used for the Test Set and the Data Provenance
The provided 510(k) summary does not include details on the specific sample sizes used for the validation or test sets. Similarly, data provenance (e.g., country of origin of data, retrospective or prospective) for the performance evaluation is not specified. For in vitro diagnostics, performance studies typically involve testing a statistically significant number of known positive and negative urine samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
For an in vitro diagnostic device like this, the "ground truth" is established through highly accurate analytical methods in a laboratory setting, rather than through expert human interpretation of images.
- Ground Truth Establishment: The document explicitly states: "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 Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) would be used to objectively determine the true presence and concentration of drugs in urine samples, serving as the gold standard.
- Experts: The "experts" involved would be highly skilled analytical chemists or laboratory professionals proficient in operating and interpreting results from GC/MS or LC/MS systems. The number and specific qualifications are not mentioned in this summary.
4. Adjudication Method for the Test Set
Not applicable in the conventional sense. The "adjudication" for an immunoassay largely relies on the objective results from the confirmatory chemical methods (GC/MS or LC/MS) rather than a consensus among human reviewers. Discrepancies between the immunoassay and the confirmatory method would be analyzed to understand the immunoassay's performance characteristics (e.g., false positives/negatives).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
Not applicable. MRMC studies are typically used to assess algorithmic performance in interpretation tasks that traditionally involve human readers (e.g., radiology, pathology). This device is a biochemical assay for drug detection, not an interpretive algorithm.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This device operates as a standalone diagnostic test. Humans are involved in applying the sample and visually reading the result (presence/absence of a line), but the core detection mechanism is an immunoassay, not an AI algorithm. The performance evaluation would inherently be "standalone" in the sense of the immunoassay itself, without requiring human "interpretation" beyond reading the literal presence or absence of a line.
7. The Type of Ground Truth Used
The ground truth used for validating this device would be definitive analytical testing, specifically GC/MS or LC/MS, as stated in the intended use: "GC/MS or LC/MS is the preferred confirmatory method."
8. The Sample Size for the Training Set
Not applicable in the context of an immunoassay. Immunoassays are not "trained" in the way AI/ML algorithms are. Their performance is inherent to their biochemical design (antibodies, reagents, flow characteristics). Therefore, there is no "training set" in the AI/ML sense.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for this type of device.
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).