(69 days)
The ACON multi-CLIN™ Drug Screen Test Device is a rapid chromatographic immunoassays for the qualitative and simultaneous detection of Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methylenedioxymethamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants in human urine at cut-off concentrations:
1,000 ng/mL Amphetamine
300 ng/mL Barbiturates
300 ng/mL Benzodiazepines
300 ng/mL Cocaine
50 ng/mL Marijuana
500 ng/mL Methylenedioxymethamphetamine
300 ng/mL Opiates
100 ng/mL Oxycodone
25 ng/mL Phencyclidine
300 ng/mL Propoxyphene
1,000 ng/mL Tricyclic Antidepressants
They are intended for healthcare professional use only including professionals at the point of care sites.
This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is 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 used.
The ACON multi-CLIN™ Drug Screen Test Device is a competitive binding, lateral flow immunochromatographic assay for the qualitative and simultaneous detection of Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methylenedioxymethamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants in human urine.
The test is based on the principle of antigen-antibody immunochemistry. It utilizes mouse monoclonal antibodies to selectively detect elevated levels of Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methylenedioxymethamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants in human urine. These tests can be performed without the use of an instrument.
A drug-positive urine specimen will not generate a colored-line for the specific drug tested in the designated test region. A negative urine specimen or a urine specimen containing the drug concentration below the cut-off level will generate a colored-line in the designated test region for the drug. To serve as a procedural control, there must be no line next to the Positive Control Region (POS) and a clear line will always appear in the Negative Control region (NEG), indicating that sufficient volume of specimen applied and proper membrane wicking occurred. If NO line appears in the Negative Control region (NEG) and/or a line withing other Positive Control Region (POS) during testing, the test becomes INVALID. A true positive control is incorporated in each test strip employed.
Here's a breakdown of the acceptance criteria and study details for the ACON multi-CLIN™ Drug Screen Test Device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the desired level of agreement for each drug tested, as demonstrated by the study results when compared to GC/MS analysis. While explicit percentage targets aren't listed as "acceptance criteria," the reported performance in the table below represents what was accepted as substantially equivalent.
| Analyte (Drug) | Performance Measure | Acceptance Criteria (Implied by Study) | Reported Device Performance |
|---|---|---|---|
| Amphetamine (AMP) | Positive Agreement | High (>90%) | 99% (134/136) |
| Negative Agreement | High (>90%) | 98% (308/314) | |
| Overall Agreement | High (>90%) | 98% (442/450) | |
| Barbiturates (BAR) | Positive Agreement | High (>90%) | 98% (99/101) |
| Negative Agreement | High (>90%) | 99% (305/309) | |
| Overall Agreement | High (>90%) | 99% (404/410) | |
| Benzodiazepines (BZO) | Positive Agreement | High (>90%) | >99% (139/140) |
| Negative Agreement | High (>90%) | >99% (308/310) | |
| Overall Agreement | High (>90%) | >99% (447/450) | |
| Cocaine (COC) | Positive Agreement | High (>90%) | >99% (119/119) |
| Negative Agreement | High (>90%) | 95% (308/325) | |
| Overall Agreement | High (>90%) | 96% (427/444) | |
| Marijuana (THC) | Positive Agreement | High (>90%) | 96% (116/121) |
| Negative Agreement | High (>90%) | 95% (311/327) | |
| Overall Agreement | High (>90%) | 95% (427/448) | |
| MDMA | Positive Agreement | High (>90%) | >99% (88/88) |
| Negative Agreement | High (>90%) | 99% (301/305) | |
| Overall Agreement | High (>90%) | 99% (389/393) | |
| Opiates (OPI) | Positive Agreement | High (>90%) | >99% (140/140) |
| Negative Agreement | High (>90%) | 97% (300/309) | |
| Overall Agreement | High (>90%) | 98% (440/449) | |
| Oxycodone (OXY) | Positive Agreement | High (>90%) | 99% (140/141) |
| Negative Agreement | High (>90%) | 99% (306/309) | |
| Overall Agreement | High (>90%) | 99% (446/450) | |
| Phencyclidine (PCP) | Positive Agreement | High (>90%) | 99% (85/86) |
| Negative Agreement | High (>90%) | 99% (300/304) | |
| Overall Agreement | High (>90%) | 99% (385/390) | |
| Propoxyphene (PPX) | Positive Agreement | High (>90%) | >99% (145/146) |
| Negative Agreement | High (>90%) | >99% (304/304) | |
| Overall Agreement | High (>90%) | >99% (449/450) | |
| Tricyclic Antidepressants (TCA) | Positive Agreement | High (>80%) | >99% (32/32) |
| Negative Agreement | High (>80%) | 93% (316/338) | |
| Overall Agreement | High (>80%) | 94% (348/370) |
Note: The specific percentage acceptance criteria are not explicitly stated in the provided text, but the strong agreement percentages demonstrate that the device met the requirements for substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 1,704 clinical urine specimens.
- Data Provenance: The data was from "clinical urine specimens," implying human samples, and a portion (approximately 10%) included samples with drug concentrations in the -25% to +25% cut-off range to challenge the device at critical concentrations. The country of origin is not specified but given the FDA submission, it's likely US-based or intended for the US market. The study was retrospective in nature as it compared the device against existing predicate devices and customary GC/MS analysis.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) analysis, which is an analytical instrument-based method, not human expert interpretation in this context.
- Qualifications of Experts: Not applicable, as GC/MS is a laboratory analytical method.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The ground truth was established by GC/MS, which provides quantitative, objective results. Discrepancies would be resolved through re-testing or review of the GC/MS data, rather than expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on the standalone analytical accuracy of the device against a gold standard (GC/MS).
- Effect Size of AI Improvement: Not applicable, as this was not an AI-assisted human reader study.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study: Yes, a standalone study was performed. The "ACON Multi-CLIN™ Drug Screen Test Device vs. GC/MS Analysis" section directly reports the performance of the device (product) working independently, compared to the GC/MS gold standard. There is no mention of human interpretation being part of the device's output or a human-in-the-loop process for these results. The device itself produces the qualitative result (positive/negative).
7. Type of Ground Truth Used
- Type of Ground Truth: Gas Chromatography/Mass Spectrometry (GC/MS) analysis. GC/MS is considered the gold standard for confirmatory drug testing due to its sensitivity and specificity in identifying and quantifying substances.
8. Sample Size for the Training Set
- Sample Size for Training Set: The document does not specify a separate training set. The clinical evaluation used 1,704 clinical specimens for testing the device's performance. For immunoassay devices like this, the "training" (development and calibration) would typically involve internal laboratory studies using spiked samples and known-concentration controls during the manufacturing and R&D phases, but a distinct "training set" for an algorithm in the sense of machine learning is not mentioned as this is a chemical immunoassay device.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not explicitly stated in the document, as a training set for an algorithm is not described. For the general development of such immunoassay devices, ground truth for calibration and initial validation (analogous to training) would typically be established using:
- Known concentrations of drugs or their metabolites prepared in a laboratory.
- Certified reference materials.
- Laboratory analysis using established methods like GC/MS to confirm the actual concentrations in prepared samples.
§ 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).