(29 days)
The Wondfo CR3 Keyless Split Sample Cup is a competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Oxycodone, Buprenorphine, Methadone and Notriptyline in human urine at the cutoff concentrations of:
| Drug(Identifier) | Cut-off level |
|---|---|
| Amphetamine | 1000 ng/mL |
| Secobarbital | 300 ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine | 300 ng/mL |
| Cannabinoids | 50 ng/mL |
| Methamphetamine | 1000 ng/mL |
| Methylenedioxymethamphetamine | 500 ng/mL |
| Morphine | 300 ng/mL or 2000 ng/mL |
| Phencyclidine | 25 ng/mL |
| Oxycodone | 100 ng/mL |
| Buprenorphine | 10 ng/mL |
| Methadone | 300 ng/mL |
| Notriptyline | 1000ng/mL |
Configuration of the Wondfo CR3 Keyless Split Sample Cup can consist of any combination of the above listed drug analytes.
The test provides only preliminary test results. A more specific alternative chemical 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 Buprenorphine. Oxazepam, Oxycodone and Secobarbital are ingested, even at or above therapeutic doses. It is not intended to distinguish between prescription use or abuse of these drugs.
Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
The Wondfo CR3 Keyless Split Sample Cup uses immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Phencyclidine, Oxycodone Buprenorphine, Methadone and Notriptyline in human urine samples. The test is a lateral flow, competitive binding system. The test is the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.
Here's a breakdown of the acceptance criteria and study information for the Wondfo CR3 Keyless Split Sample Cup, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the device as a qualitative test, meaning it determines the presence or absence of a substance, not its exact quantity. The performance is assessed against specific cut-off levels for each drug. The provided text, however, focuses on analytical performance being established in previous 510(k) submissions for individual drug tests and then verifying functionality in a multi-drug cup configuration. It explicitly states: "The test strips of the candidate device are the same as those cleared with the predicate devices. Drug cutoffs of the candidate device are also identical to the predicate devices. Analytical performance was established for each device in the submissions as stated below."
Therefore, the acceptance criteria are implicitly tied to the performance demonstrated in those predicate device submissions. The table below lists the drugs and their cut-off levels, which are the primary performance metric. The "Reported Device Performance" here refers to the device's ability to qualitatively detect these drugs at or above these cut-off levels, which was verified to be consistent with the predicate.
| Drug (Identifier) | Acceptance Criteria (Cut-off level) | Reported Device Performance (as stated in document) |
|---|---|---|
| Amphetamine (AMP) | 1000 ng/mL | Qualitatively detects at/above cut-off |
| Secobarbital (BAR) | 300 ng/mL | Qualitatively detects at/above cut-off |
| Oxazepam (BZO) | 300 ng/mL | Qualitatively detects at/above cut-off |
| Cocaine (COC) | 300 ng/mL | Qualitatively detects at/above cut-off |
| Cannabinoids (THC) | 50 ng/mL | Qualitatively detects at/above cut-off |
| Methamphetamine (MET) | 1000 ng/mL | Qualitatively detects at/above cut-off |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL | Qualitatively detects at/above cut-off |
| Morphine (MOP) | 300 ng/mL or 2000 ng/mL | Qualitatively detects at/above cut-off |
| Phencyclidine (PCP) | 25 ng/mL | Qualitatively detects at/above cut-off |
| Oxycodone (OXY) | 100 ng/mL | Qualitatively detects at/above cut-off |
| Buprenorphine (BUP) | 10 ng/mL | Qualitatively detects at/above cut-off |
| Methadone (MTD) | 300 ng/mL | Qualitatively detects at/above cut-off |
| Notriptyline (TCA) | 1000 ng/mL | Qualitatively detects at/above cut-off |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not explicitly state a specific sample size for the current 510(k) submission's test set. It refers to "verification studies" for the multi-drug cup modification, including interference studies and a lay-user study. The analytical performance was established in previous 510(k) submissions (e.g., K141532 for Amphetamine). To get the detailed sample sizes for the analytical performance, one would need to refer to those predicate submissions.
- Data Provenance: The document does not specify the country of origin for the data used in the "verification studies" or the previous analytical performance studies. It mentions the submitter is Guangzhou Wondfo Biotech Co., Ltd., from P.R. China, but this doesn't directly indicate where the clinical or analytical samples were sourced. The studies appear to be retrospective in the sense that the individual drug test performance was already established and used, but the verification of the multi-drug cup format would likely involve prospective testing with new samples in the modified device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
The document does not provide this information. Given that this is an in vitro diagnostic device for drug detection in urine, the "ground truth" for analytical performance is typically established by reference laboratory methods (e.g., GC/MS or LC/MS), not human expert consensus on subjective interpretations. For the lay-user study, if included, experts might be involved in evaluating user comprehension and performance, but this is not detailed.
4. Adjudication Method for the Test Set:
Not applicable. For a qualitative drug test where ground truth is established by chemical analysis (GC/MS or LC/MS), there is no need for expert adjudication in the traditional sense, as the reference method provides a definitive result.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with image-based diagnostics where multiple readers interpret cases and their performance is compared with and without AI assistance. The Wondfo CR3 Keyless Split Sample Cup is a rapid, qualitative immunoassay for drug detection, where the result is typically read visually as "positive" or "negative" based on line appearance, not complex interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, the analytical performance studies (both for the predicate devices and the verification studies for the new cup format) represent standalone performance. The device itself produces a visual result, and its accuracy is tested against a chemical comparator without a human actively "interpreting" or making a diagnostic decision beyond reading the visual output. The device's performance is independent of human interpretation variability once the result lines are formed.
7. The Type of Ground Truth Used:
The primary type of ground truth used would be chemical analysis, specifically GC/MS or LC/MS (Gas Chromatography/Mass Spectrometry or Liquid Chromatography/Mass Spectrometry). The document explicitly states: "A more specific alternative chemical 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 serve as the gold standard for confirming drug presence and concentration.
8. The Sample Size for the Training Set:
The document does not explicitly state a sample size for the training set. For in vitro diagnostic devices like this, antibody and assay development would involve extensive experimentation and optimization (which can be considered analogous to "training") using a variety of standards and spiked samples, but a formal "training set" in the machine learning sense is not typically described in these submissions. The analytical performance data from the predicate devices could be considered the "learned" performance that the new device aims to replicate in its modified format.
9. How the Ground Truth for the Training Set Was Established:
As above, the concept of a "training set" in the machine learning context isn't directly applicable here. For the development and optimization of the assays (the "training" equivalent), ground truth would have been established using known concentrations of drug analytes and metabolites in synthetic or drug-free human urine samples, confirmed through highly accurate analytical methods like GC/MS or LC/MS. This allows for precise calibration and characterization of the assay's sensitivity and specificity.
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).