(68 days)
The Nano-Check™ DAT 5 Multi Drug Screening Test for Marijuana, Opiates, Cocaine, Methamphetamine and Phencyclidine is a rapid, self-controlled immunoassay for the qualitative detection of Cannabinoids (THC), Opiates (OPI), Benzoylecgonine (COC), Methamphetamine (mAMP) and Phencyclidine (PCP) compounds and their metabolites in human urine. The detection limits (cut-off concentrations) of this test are as follows: Cannabinoids at 50 ng/ml, Opiates at 2000 ng/ml, Cocaine at 300 ng/ml, Methamphetamine at 1000 ng/ml and Phencyclidine at 25 ng/ml. This assay is intended for Professional and Laboratory In-Vitro Use Only.
The Nano-Check™ DAT 5M test is a one step, type II, competitive immuochromatographic assay for the qualitative detection of Cannabinoid, Opiate, Benzoylecgonine, Methamphetamine and Phencyclidine compounds and their metabolites in human urine. The Nano-Check™ DAT 5M test device contains a membrane strip on which either antibodies against drug or drug conjugate to protein are immobilized at each specific test line. The colored indicator antibody or antigen coupled with Gold colloidal particles is place at the end of membrane.
The test is a single-use visually read cassette device in a plastic housing. It contains the test strip containing 5 test lines and 1 control line. Urine sample can be dropped onto sample well using plastic disposable dropper, which is provided. Drug positive urines will not show a colored band, while drug negative urine sample or urine sample containing drugs below cutoff level will generate red colored band.
The device is sealed in a pouch desiccant and provided with instructions for use and a disposable sample dropper.
The provided document describes the Nano-Check™ DAT 5 Multi Drug Screening Test for Cannabinoids (THC), Opiates (OPI), Cocaine (COC), Methamphetamine (mAMP), and Phencyclidine (PCP).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) with specific thresholds. Instead, it focuses on demonstrating substantial equivalence to predicate devices. The "acceptance criteria" can be inferred from the comparison table highlighting similarities and the successful outcome of the non-clinical tests. The primary performance characteristic mentioned is the detection limits (cut-off concentrations).
| Performance Metric | Acceptance Criteria (Implicit from Predicate Devices) | Reported Device Performance |
|---|---|---|
| Cut-off Concentration | THC: 50 ng/ml | THC: 50 ng/ml |
| OPI: 2000 ng/ml | OPI: 2000 ng/ml | |
| COC: 300 ng/ml | COC: 300 ng/ml | |
| mAMP: 1000 ng/ml | mAMP: 1000 ng/ml | |
| PCP: 25 ng/ml | PCP: 25 ng/ml | |
| Test Principle | Immunochromatographic, lateral-flow, competitive assay | Same |
| Type of test | Qualitative | Same |
| Assay time | 10 min | Same |
| Sample type | Human urine | Same |
| Intended use | Professional use | Same |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states "Discussion of Clinical Tests Performed: Not Applicable." This indicates that no clinical test set with human subject samples was used for this submission. The evaluation was based on non-clinical tests performed to demonstrate analytical performance and comparison to predicate devices.
Therefore:
- Sample size for the test set: Not applicable (no clinical test set).
- Data provenance: Not applicable (no clinical data).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since no clinical tests were performed and thus no clinical test set was used, there were no experts involved in establishing ground truth for a clinical test set.
4. Adjudication Method for the Test Set
As there was no clinical test set involved, there was no adjudication method applied.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission explicitly states "Discussion of Clinical Tests Performed: Not Applicable," and the performance evaluation was based on analytical characteristics and comparison to existing predicate devices.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, in a sense, a "standalone" performance was evaluated, though it's important to clarify the context. The device is a visually read cassette, meaning a human reads the results. However, the tests performed (analytical performance, detection limit, specificity, etc.) evaluate the device's intrinsic ability to detect the drugs at specified cut-off levels prior to human interpretation. The analytical performance data represents this standalone capability.
7. The Type of Ground Truth Used
The ground truth for the non-clinical tests would have been established by:
- Known concentrations of drug analytes: For tests like precision/reproducibility, detection limit, and assay cut-off, spiked urine samples or controlled synthetic urine samples with precisely known concentrations of the target drugs and their metabolites would be used.
- Known interfering substances: For analytical specificity, samples with known concentrations of potential interfering substances would be used.
- Predicate device results: For method comparison studies, the results obtained from the predicate devices (ACON test strips) on the same samples would serve as a comparative "ground truth."
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning or AI. This device is an immunoassay, not an AI/ML device, so typical AI training sets do not apply. The development process would have involved internal validation and optimization, but not typically referred to as a "training set" in this manner.
9. How the Ground Truth for the Training Set Was Established
Since this is not an AI/ML device, the concept of a training set and its ground truth in that context is not applicable. The assay's parameters (e.g., antibody concentrations, membrane properties) would have been optimized during its development using controlled experiments with known concentrations of analytes, similar to the ground truth described in point 7.
§ 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).