(46 days)
BIOEASY Multi-Drug Test Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of:
| Drug(Identifier) | Cut-off level |
|---|---|
| Amphetamine | 1000 ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine | 300 ng/mL |
| Marijuana | 50 ng/mL |
| Methamphetamine | 1000 ng/mL |
| Morphine | 300 ng/mL or 2000 ng/mL |
| Oxycodone | 100 ng/mL |
| Secobarbital | 300 ng/mL |
| Buprenorphine | 10 ng/mL |
| Methylenedioxy-methamphetamine | 500 ng/mL |
| Phencyclidine | 25 ng/mL |
| Methadone | 300 ng/mL |
| Nortriptyline | 1000 ng/mL |
| d-Propoxyphene | 300 ng/mL |
Configuration of the BIOEASY Multi-Drug Test Cup tests can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed 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 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.
For in vitro diagnostic use only.
The BIOEASY Multi-Drug Test Cup tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine, Phencyclidine, Methadone, Nortriptyline and Propoxyphene (target analytes) in human urine. The products are single-use in vitro diagnostic devices. Each test kit contains a Test Device, a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch
The provided document describes the performance of the BIOEASY Multi-Drug Test Cup, an in-vitro diagnostic device for qualitative and simultaneous detection of various drugs in human urine. Here's a breakdown of the acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in a separate table. However, the performance is demonstrated through precision studies and lay-user studies, showing the device's ability to correctly identify drug presence/absence at specific concentrations relative to the defined cutoff levels. The implicit acceptance criteria appear to be high percentages of correct results, particularly at and beyond the +/- 25% cutoff concentrations. For the lay user study, 90-100% correct results were generally achieved across different drug panels and concentrations close to the cutoff, with 100% correct results for samples far from the cutoff.
Here's an aggregated summary of the performance for each drug panel from the lay user study, which serves as a key indicator of device performance in the hands of intended users:
| Drug Panel (Cut-off) | % Correct Results (-100% Cutoff) | % Correct Results (-75% Cutoff) | % Correct Results (-50% Cutoff) | % Correct Results (-25% Cutoff) | % Correct Results (+25% Cutoff) | % Correct Results (+50% Cutoff) | % Correct Results (+75% Cutoff) |
|---|---|---|---|---|---|---|---|
| Amphetamine (1000 ng/mL) | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| Secobarbital (300 ng/mL) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| Cocaine (300 ng/mL) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| Buprenorphine (10 ng/mL) | 100% | 100% | 100% | 95% | 90% | 100% | 100% |
| Methamphetamine (1000 ng/mL) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| Methadone (300 ng/mL) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| Morphine (2000 ng/mL) | 100% | 100% | 100% | 100% | 95% | 100% | 100% |
| Oxycodone (100 ng/mL) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| Phencyclidine (25 ng/mL) | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| Marijuana (50 ng/mL) | 100% | 100% | 100% | 90% | 95% | 100% | 100% |
| Oxazepam (300 ng/mL) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| MDMA (500 ng/mL) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| Nortriptyline (1000 ng/mL) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| Propoxyphene (300 ng/mL) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Precision Studies: For each drug concentration point tested (-100% cut off, -75% cut off, -50% cut off, -25% cut off, +25% cut off, +50% cut off, +75% cut off, and +100% cut off), tests were performed for 25 days per device, with two runs per day for each drug. This means 50 runs per concentration for each drug across three lots (total of 150 runs per concentration per drug across lots). The samples were prepared in-house by spiking drugs into negative samples. The data provenance is implied to be from the manufacturer's lab, likely Shenzhen, China, where the submitter is located. This appears to be a prospective internal study.
- Method Comparison Studies: 80 (40 negative and 40 positive) unaltered clinical samples for each drug were used. The samples were blind labeled. These appear to be retrospective clinical samples, but the country of origin is not specified.
- Lay-user Study: 300 lay persons participated. Urine samples were prepared at varying concentrations: negative, +/-75%, +/-50%, +/-25% of the cutoff. Each participant received one blind-labeled sample and one device. The number of samples tested at each concentration varied per drug, as shown in the tables (e.g., 20 samples for -100% cutoff, 160 for -50% cutoff, 40 for +50% cutoff). These were likely prepared in-house or externally for the study, making it a prospective study, though the country of origin for the lay users is not specified (but likely related to the submitter's regions of operation or intended market).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Precision and Lay-user Studies: The "ground truth" for the urine samples in these studies was established by LC/MS (Liquid Chromatography/Mass Spectrometry) or LC/MS/MS, which is a gold standard analytical method for drug concentration determination. The number or qualifications of the individuals performing the LC/MS analysis are not specified, but it's presumed to be trained laboratory personnel.
- Method Comparison Studies: The ground truth for the 80 clinical samples was also established by LC/MS. The number or qualifications of the individuals performing the LC/MS analysis are not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Precision Studies: The document doesn't explicitly state an adjudication method. "All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing." The results presented are counts of "positive" and "negative" outcomes.
- Method Comparison Studies: The studies were performed in-house with three laboratory assistants for each device. The results are summarized by "Viewer A," "Viewer B," and "Viewer C." This indicates a multi-reader approach. However, there's no mention of an adjudication process (e.g., 2+1, 3+1) if their readings disagreed. The discordant results table lists individual discrepancies.
- Lay-user Study: Each participant tested one device and recorded their results. The assessment of whether their result was "correct" was based on the LC/MS confirmed concentration of the sample they received. No adjudication among lay users is mentioned or appropriate for this type of study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human readers improving with AI vs. without AI assistance was not done. This device is a lateral flow immunoassay, a point-of-care test that human users (including lay users) interpret visually. It is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm-only performance study was not done, as this device does not incorporate an AI algorithm. Its performance is based on the chemical reaction and visual interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used for validating the device's performance was primarily analytical confirmation by LC/MS or LC/MS/MS. This is considered a highly accurate and quantitative laboratory diagnostic method for determining drug concentrations.
8. The sample size for the training set
The document does not describe a "training set" in the context of an AI/ML algorithm. This device is a lateral flow immunoassay and does not employ machine learning or AI that would require a separate training dataset. The studies described are for analytical and clinical validation of the immunoassay.
9. How the ground truth for the training set was established
As there is no AI/ML component mentioned and thus no "training set," this question is not applicable to the information provided.
§ 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).