(278 days)
The Applied DNA Technologies Bionexia™ DOA Panels are rapid chromatographic immunoassays for the qualitative and simultaneous detection of one to thirteen of the following drugs in a variety of combinations in human urine. The designed cutoff concentrations and direct calibrator for these drugs are as follows:
| Analyte | Abbreviation | Calibrator | Cutoff Concentration |
|---|---|---|---|
| Amphetamine | AMP | Amphetamine | 1000 ng/ml |
| Barbiturate | BAR | Secobarbital | 300 ng/ml |
| Benzodiazepines | BZO | Oxazepam | 300 ng/ml |
| Cocaine | COC | Benzoylecgonine | 300 ng/ml |
| Marijuana | THC | 11-nor- $\Delta^{9}$ -THC9-COOH | 50 ng/ml |
| Methamphetamine | MET | Methamphetamine | 1000 ng/ml |
| Methadone | MTD | Methadone | 300 ng/ml |
| Morphine | MOR | Morphine | 2000 ng/ml |
| Morphine | MOR | Morphine | 300 ng/ml |
| Phencyclidine | PCP | Phencyclidine | 25 ng/ml |
| Nortriptyline | NOR | Nortriptyline | 1000 ng/ml |
| Ecstasy | MDMA | 3,4-Methylenediioxy-MET | 500 ng/ml |
| Buprenorphine | BUP | BUP-3-D-Glucuronide | 10 ng/ml |
| EDDP | EDDP | 2-ethylidene-1,5-dimethyl- | |
| 3,3-diphenylpyrrolidine | 100 ng/ml |
For health care professionals use including professionals at point of care sites (POC) to assist in the determination of drug compliance.
This assay provided only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory method.
Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
One-step, colloidal gold based chromatographic immunoassay for the rapid, qualitative detection of Marijuana, Cocaine, Phencyclidine, Morphine, Methamphetamine, Methadone, Amphetamine, Barbiturates, Benzodiazepines, Nortriptyline, Ecstasy, Buprenorphine and Methadone metabolite -EDDP, in human urine.
This document describes the validation of the Bionexia™ Single and Multi-Strip Cassette/Dipstick DOA Screen Panels for detecting various drugs of abuse in human urine.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the reported "Overall Agreement" percentages, which demonstrate the device's accuracy compared to confirmatory methods (GC/MS or LC/MS). While explicit numerical acceptance criteria for each analyte are not stated, the consistently high agreement rates (all above 93%) suggest a benchmark for acceptable performance.
| Analyte | Reported Agreement (Previously Approved Panels) | Reported Agreement (Additional Panels) |
|---|---|---|
| Amphetamine (AMP) | 98.1% | N/A |
| Barbiturate (BAR) | 98.0% | N/A |
| Benzodiazepines (BZO) | 93.9% | N/A |
| Cocaine (COC) | 98.2% | N/A |
| Methamphetamine (MET) | 98.3% | N/A |
| Morphine (MOR) | 98.1% | 97.9% (for 300 ng/ml cutoff) |
| Methadone (MTD) | 98.1% | N/A |
| Phencyclidine (PCP) | 98.9% | N/A |
| Nortriptyline (NOR) | 96.8% | N/A |
| Marijuana (THC) | 97.5% | N/A |
| MDMA | N/A | 100.0% |
| EDDP | N/A | 100.0% |
| Buprenorphine (BUP) | N/A | 100.0% |
Note: For analytes listed in both tables, the 'Previously Approved Panels' table likely refers to clinical specimen correlation against GC/MS/LC/MS, while the 'Additional Panels' table further breaks down agreement by concentration range for newer analytes. The morphine (MOR) entry appears twice with different cutoffs, 2000 ng/ml in the first table and 300 ng/ml in the second.
2. Sample Sizes and Data Provenance
Previously Approved Panels (Table 1):
The sample sizes for the test set vary by analyte and are provided as the denominator in the agreement percentages. For example:
- AMP: 103 samples
- BAR: 98 samples
- BZO: 99 samples
- COC: 110 samples
- MET: 115 samples
- MOR (2000 ng/ml): 105 samples
- MTD: 105 samples
- PCP: 94 samples
- NOR: 95 samples
- THC: 122 samples
Additional Panels (Table 2):
For each drug, the total number of samples is the sum of all categories (No Drug present, Negative, Near-Cutoff Negative, Near-Cutoff Positive, High Positive). For example:
- MDMA: 35 + 7 + 9 + 12 + 63 = 126 samples
- EDDP: 38 + 0 + 4 + 1 + 65 = 108 samples
- BUP: 35 + 1 + 5 + 0 + 72 = 113 samples
- MOR (300 ng/ml): 35 + 0 + 12 + 2 + 50 = 99 samples
Data Provenance: The data is derived from "blind-labeled clinical specimen correlation study" and "blind-labeled spiked control studies including point-of-care site study." This indicates the data is retrospective (clinical specimens) and prospective (spiked control studies). The country of origin for the data is not specified, but the submission is to the U.S. FDA, suggesting the studies were conducted to U.S. regulatory standards.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of human experts to establish ground truth for the test set. Instead, the ground truth is established by "Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) methodology," which are analytical chemical methods.
4. Adjudication Method for the Test Set
Since the ground truth is established by GC/MS or LC/MS, there is no human adjudication method (e.g., 2+1, 3+1) described or implied for the test set. The device results are directly compared to the analytical results from the confirmatory methods.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no MRMC comparative effectiveness study mentioned in the document. The study focuses on the performance of the Bionexia™ device compared to predicate devices and confirmatory chemical methods. There is no information provided regarding human readers' performance with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was conducted. The tables provided (Table 1 and Table 2) detail the Bionexia™ device's performance (algorithm only, as it's an immunoassay) against the gold standard methods (GC/MS or LC/MS) or predicate devices. This represents the device's performance without a human-in-the-loop directly influencing the test result interpretation (though a healthcare professional would interpret the device's output).
7. Type of Ground Truth Used
The type of ground truth used is confirmatory analytical chemical methods, specifically Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS). The document explicitly states these are "the preferred confirmatory method."
8. Sample Size for the Training Set
The document does not provide information regarding a separate "training set" or its sample size. The studies described are performance evaluations, implying these samples were used for validation rather than algorithm training. For a traditional immunoassay, there wouldn't typically be an "algorithm training set" in the same sense as machine learning. The device's characteristics are determined during its development and manufacturing process, then validated against known samples.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set in the context of algorithm development, there is no information on how its ground truth was established. For the validation/test sets, as described in point 7, the ground truth was established using GC/MS or LC/MS.
§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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).