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510(k) Data Aggregation
(73 days)
The ACON TRI-fect™ Drug Screen Test Device is a rapid chromatographic immunoassay 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.
The ACON TRI-fect" 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, a colored line will always appear at the control region (CTL), indicating that sufficient volume of specimen applied and proper membrane wicking occurred. If a control line fails to develop during testing, the test becomes invalid.
Acceptance Criteria and Study for ACON TRI-fect™ Drug Screen Test Device
1. Table of Acceptance Criteria and Reported Device Performance:
The acceptance criteria for the ACON TRI-fect™ Drug Screen Test Device are implied by the "substantial equivalency" determination to previously FDA-cleared predicate devices and comparison to GC/MS analysis. The reported device performance is presented as Positive Agreement, Negative Agreement, and Overall Agreement with GC/MS analysis. While specific numerical acceptance thresholds are not explicitly stated in this document (e.g., "must be >95%"), the reported performance is expected to demonstrate high agreement for all analytes.
Here is the table summarizing the device performance against the gold standard (GC/MS):
| Analyte | Cut-off Concentration (ng/mL) | Positive Agreement (95% CI) | Negative Agreement (95% CI) | Overall Agreement (95% CI) |
|---|---|---|---|---|
| Amphetamine (AMP) | 1,000 | 99% (95% - 99%) | 98% (96% - 99%) | 98% (97% - 99%) |
| Barbiturates (BAR) | 300 | 98% (93% - 99%) | 99% (97% - 99%) | 99% (97% - 99%) |
| Benzodiazepines (BZO) | 300 | 96% (92% - 99%) | >99% (98% - 99%) | 98% (97% - 99%) |
| Cocaine (COC) | 300 | >99% (97% - 99%) | 95% (92% - 97%) | 96% (94% - 98%) |
| Marijuana (THC) | 50 | 96% (91% - 99%) | 95% (92% - 97%) | 95% (93% - 97%) |
| Methylenedioxymethamphetamine (MDMA) | 500 | >99% (96% - 99%) | 99% (97% - 99%) | 99% (97% - 99%) |
| Opiates (OPI) | 300 | >99% (97% - 99%) | 97% (95% - 99%) | 98% (96% - 99%) |
| Oxycodone (OXY) | 100 | 99% (96% - 99%) | 99% (97% - 99%) | 99% (98% - 99%) |
| Phencyclidine (PCP) | 25 | 99% (94% - 99%) | 99% (97% - 99%) | 99% (97% - 99%) |
| Propoxyphene (PPX) | 300 | >99% (96% - 99%) | >99% (99% - 99%) | >99% (99% - 99%) |
| Tricyclic Antidepressants (TCA) | 1,000 | >99% (89% - 99%) | 93% (90% - 96%) | 94% (91% - 96%) |
Note: For entries like ">99%", the document clarifies this indicates a 97.5% confidence interval since the proportion cannot go above 100%.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: 1,704 clinical urine specimens.
- Data Provenance: The document states "clinical evaluation was conducted using clinical urine specimens." The country of origin is not specified, but the submission is from ACON Laboratories, Inc. in San Diego, California, USA. The data is retrospective as it uses existing "clinical urine specimens" compared against previously obtained GC/MS data and previously FDA-cleared single drug tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) analysis. This is an analytical chemical method and does not typically involve human "experts" in the same way clinical adjudication does. GC/MS results are considered the definitive chemical confirmation for drug presence and concentration. Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth via GC/MS is not applicable in this context.
4. Adjudication method for the test set:
The adjudication method was a direct comparison of the ACON TRI-fect™ Drug Screen Test Device results against GC/MS analysis data. Discrepancies (e.g., presumptive positive by device, negative by GC/MS, or vice-versa) would be noted and reported in the agreement percentages, but the GC/MS result served as the final arbiter for ground truth. There is no mention of a human expert adjudication process (e.g., 2+1) in this document.
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 was not done. This device is an immunoassay for drug detection, not an AI-assisted diagnostic device interpreted by human readers. Therefore, the concept of human reader improvement with/without AI assistance and effect size is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Yes, a standalone performance evaluation was done. The ACON TRI-fect™ Drug Screen Test Device is itself a rapid immunoassay test kit that provides a qualitative result (presence/absence of a line) without the need for human interpretation beyond reading the visual result. Its performance was directly compared against the GC/MS ground truth, which represents its standalone accuracy.
7. The type of ground truth used:
The primary ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS) analysis. This is a highly accurate and widely accepted method for confirming the presence and concentration of drugs in biological samples.
8. The sample size for the training set:
The document does not explicitly state a separate "training set" or its sample size. The description pertains to a "clinical evaluation" which typically refers to a validation or test set for an already developed device. Immunoassays like this generally do not involve a traditional "training set" in the machine learning sense, as they are based on specific antigen-antibody reactions, not learned algorithms.
9. How the ground truth for the training set was established:
As no separate training set is explicitly mentioned or relevant in the context of this immunoassay device, the method for establishing its ground truth is not applicable. The development of such devices relies on chemical principles and validation against known concentrations and external comparators.
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