(59 days)
The ACON Spectrum Multi-Drug Multi-Line Drug Screen Test Card and ACON Spectrum Multi-Drug Multi-Line Drug Screen Test Card with three types of Integrated Cups (ACON 006 Cup or RediCup, ACON 008 Cup or iCup and ACON 009 Cup or E-Z Split Key Cup) are rapid chromatographic immunoassays for the qualitative and simultaneous detection of Marijuana, Cocaine, Methamphetamine, Amphetamine, Opiates. Phencyclidine, Benzodiazepine, Methadone, Barbiturate, Tricyclic Antidepressants and Methylenedioxymethamphetamine in human urine at the cutoff concentrations of:
50 ng/mL for Marijuana, 300 ng/mL for Cocaine, 1,000 ng/mL for Methamphetamine, 1,000 ng/mL for Amphetamine, 2,000 or 300 ng/mL for Opiates (OPI2000 or MOP300), 25 ng/mL for Phencyclidine, 300 ng/mL for Benzodiazepine, 300 ng/mL for Methadone, 300 ng/mL for Barbiturate. 1,000 ng/mL for Tricyclic Antidepressants, and 500 ng/mL for Methylenedioxymethamphetamine
These assay systems can only provide a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, especially when preliminary positive results are indicated.
They are only intended for healthcare professionals including professionals at point of care sites.
The ACON Spectrum Multi-Drug Multi-Line Screen Test Card and ACON Spectrum Multi-Drug Multi-Line Screen Test Card with Integrated Cups (ACON 006 Cup or RediCup, ACON 008 Cup or iCup and ACON 009 Cup or E-Z Split Key Cup) are competitive binding, lateral flow immunochromatographic assays for the qualitative and simultaneous detection of Marijuana, Cocaine, Methamphetamine, Amphetamine, Opiates, Phencyclidine, Antidepressants Benzodiazepine. Methadone, Barbiturate, Tricyclic and Methylenedioxymethamphetamine in human urine at the cutoff concentrations of:
50 ng/mL for Marijuana. 300 ng/mL for Cocaine, 1,000 ng/mL for Methamphetamine, 1,000 ng/mL for Amphetamine, 2,000 or 300 ng/mL for Opiates (OPI2000 or MOP300), 25 ng/mL for Phencyclidine, 300 ng/mL for Benzodiazepine, 300 ng/mL for Methadone, 300 ng/mL for Barbiturate, 1,000 ng/mL for Tricyclic Antidepressants, and 500 ng/mL for Methylenedioxymethamphetamine.
These tests can be performed without the use of an instrument.
A 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 of Marijuana, Cocaine, Methamphetamine, Amphetamine, Opiates, Phencyclidine, Benzodiazepine, Methadone, Barbiturate, Tricyclic -Antidepressants and Methylenedioxymethamphetamine at the concentrations below the designated cut-off levels 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, indicating that proper volume of specimen has been added and membrane wicking has occurred.
The acceptance criteria and device performance information for the ACON Spectrum Multi-Drug Multi-Line Screen Test Card is derived from the provided text.
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes performance in terms of the ability of the device to detect specific drugs at or above certain cutoff concentrations. The "acceptance criteria" for a qualitative immunoassay like this are inherently tied to its ability to correctly identify positive and negative samples relative to these cutoffs.
| Drug | Cutoff Concentration (Acceptance Criteria) | Device Performance (How tested/described) |
|---|---|---|
| Marijuana | 50 ng/mL | Positive urine specimens do not generate a colored line. Negative urine specimens or those below cutoff generate a colored line. (Implies performance at cutoff) |
| Cocaine | 300 ng/mL | Positive urine specimens do not generate a colored line. Negative urine specimens or those below cutoff generate a colored line. (Implies performance at cutoff) |
| Methamphetamine | 1,000 ng/mL | Positive urine specimens do not generate a colored line. Negative urine specimens or those below cutoff generate a colored line. (Implies performance at cutoff) |
| Amphetamine | 1,000 ng/mL | Positive urine specimens do not generate a colored line. Negative urine specimens or those below cutoff generate a colored line. (Implies performance at cutoff) |
| Opiates (OPI2000) | 2,000 ng/mL | Positive urine specimens do not generate a colored line. Negative urine specimens or those below cutoff generate a colored line. (Implies performance at cutoff) |
| Opiates (MOP300) | 300 ng/mL | Positive urine specimens do not generate a colored line. Negative urine specimens or those below cutoff generate a colored line. (Implies performance at cutoff) |
| Phencyclidine | 25 ng/mL | Positive urine specimens do not generate a colored line. Negative urine specimens or those below cutoff generate a colored line. (Implies performance at cutoff) |
| Benzodiazepine | 300 ng/mL | Positive urine specimens do not generate a colored line. Negative urine specimens or those below cutoff generate a colored line. (Implies performance at cutoff) |
| Methadone | 300 ng/mL | Positive urine specimens do not generate a colored line. Negative urine specimens or those below cutoff generate a colored line. (Implies performance at cutoff) |
| Barbiturate | 300 ng/mL | Positive urine specimens do not generate a colored line. Negative urine specimens or those below cutoff generate a colored line. (Implies performance at cutoff) |
| Tricyclic Antidepressants | 1,000 ng/mL | Positive urine specimens do not generate a colored line. Negative urine specimens or those below cutoff generate a colored line. (Implies performance at cutoff) |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL | Positive urine specimens do not generate a colored line. Negative urine specimens or those below cutoff generate a colored line. (Implies performance at cutoff) |
2. Sample Size Used for the Test Set and Data Provenance:
The provided text does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the study). It describes the device and its intended use but does not detail the specific performance study results, including the number of samples tested to demonstrate its accuracy against the stated cutoffs.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:
The text does not mention the number or qualifications of experts used to establish ground truth for any test set. For this type of device, ground truth would typically be established by a reference chemical method (e.g., GC/MS), not by expert human interpretation of the device results.
4. Adjudication Method for the Test Set:
Since there's no mention of a test set being interpreted by human experts or clinical adjudication, there is no adjudication method described in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
This device is a rapid chromatographic immunoassay, not an AI-powered diagnostic imaging or interpretation tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human reader improvement with AI assistance was not done and is not applicable to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device itself is a standalone test; it's a "rapid chromatographic immunoassay" that can be "performed without the use of an instrument." The performance described ("A positive urine specimen will not generate a colored-line...") is the standalone performance of the device in detecting the drug. The results are visually interpreted by a healthcare professional, but the core detection mechanism is the autonomous chemical reaction within the test card.
7. The Type of Ground Truth Used:
The type of ground truth used for such a device is implied to be chemical confirmation, specifically GC/MS (Gas Chromatography/Mass Spectrometry). The document states: "A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method." This indicates that GC/MS serves as the gold standard for confirming the presence or absence of the drugs and their concentrations, against which the immunoassay's performance would be compared.
8. The Sample Size for the Training Set:
The provided text does not mention a training set sample size. This type of immunoassay device is developed through chemical and biological formulation and optimization, not typically through machine learning from a "training set" in the computational sense.
9. How the Ground Truth for the Training Set was Established:
As there is no mention of a training set in the context of machine learning, there is no information on how ground truth for a training set was established. The development and "training" of this type of device would involve laboratory testing with known concentrations of analytes and interferents to optimize the chemical reagents and physical design for accurate detection at the specified cutoffs.
§ 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).