(147 days)
The Innovacon Spectrum II Test Card and Innovacon Spectrum II Test Card with Integrated Cups (Innovacon 014 Cup or E-Z Action Multi-Drug Test Cup and Innovacon 022 Cup or E-Z Start Multi-Drug Test Cup) are rapid chromatographic immunoassays for the qualitative and simultaneous detection of Marijuana, Cocaine, Methylenedioxymethamphetamine, Methamphetamine, Phencyclidine, Morphine, Opiates, Methadone, Amphetamine, Benzodiazepine, Oxycodone, Propoxyphene, Tricyclic Antidepressants, Buprenorphine and Barbiturate in human urine at the cutoff concentrations of:
1,000 ng/mL or 300 ng/mL for Amphetamine, 300 ng/mL for Barbiturate, 300 ng/mL for Benzodiazepines, 300 ng/mL or 150 ng/mL for Cocaine, 50 ng/mL for Marijuana, 300 ng/mL for Methadone, 500 ng/mL or 1,000 ng/mL for Methamphetamine, 500 ng/mL for Methylenedioxymethamphetamine, 300 ng/mL for Morphine, 2,000 ng/mL for Opiates, 100 ng/mL for Oxycodone, 25 ng/mL for Phencyclidine, 300 ng/mL for Propoxyphene, 10 ng/mL for Buprenorphine, and 1,000 ng/mL for Tricyclic Antidepressants.
Configurations of the Innovacon Spectrum II Test Card and Innovacon Spectrum II Test Card with Integrated Cups (Innovacon 014 Cup or E-Z Action Multi-Drug Test Cup and Innovacon 022 Cup or E-Z Start Multi-Drug Test Cup) can consist of any combination of the above listed drug analytes. They are intended for healthcare professionals including professionals at 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) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The Innovacon Spectrum II Test Card and Innovacon Spectrum II Test Card with Integrated Cups (Innovacon 014 Cup or E-Z Action Multi-Drug Test Cup and Innovacon 022 Cup or E-Z Start Multi-Drug Test Cup) are competitive binding, lateral flow immunochromatographic assays for the qualitative and simultaneous detection of Marijuana, Cocaine, Methylenedioxymethamphetamine, Methamphetamine, Phencyclidine, Morphine, Opiates, Methadone, Amphetamine, Benzodiazepine, Oxycodone, Propoxyphene, Tricyclic Antidepressants, Buprenorphine and Barbiturate in human urine at the cutoff concentrations of:
1,000 ng/mL or 300 ng/mL for Amphetamine, 300 ng/mL for Barbiturate, 300 ng/mL for Benzodiazepines, 300 ng/mL or 150 ng/mL for Cocaine, 50 ng/mL for Marijuana, 300 ng/mL for Methadone, 500 ng/mL or 1,000 ng/mL for Methamphetamine, 500 ng/mL for Methylenedioxymethamphetamine, 300 ng/mL for Morphine, 2,000 ng/mL for Opiates, 100 ng/mL for Oxycodone, 25 ng/mL for Phencyclidine, 300 ng/mL for Propoxyphene, 10 ng/mL for Buprenorphine, and 1,000 ng/mL for Tricyclic Antidepressants.
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, Methylenedioxymethamphetamine, Amphetamine, Opiates, Methadone, Methamphetamine, Phencyclidine, Benzodiazepine, Propoxyphene, Tricyclic Antidepressants, Buprenorphine and Barbiturate at the concentrations below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a procedural control, a color line will always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
The provided text describes a 510(k) submission for a multi-drug screening device. While it details the device's intended use and classification, it does not include specific acceptance criteria, comprehensive performance study results (beyond stating it's "similar to other FDA-cleared devices"), or information about training data, ground truth establishment, or expert involvement in evaluation.
Therefore, many of the requested points cannot be extracted from the given input.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
Not provided in the document. The document states the device is "similar to other FDA-cleared devices for the qualitative and simultaneous detection..." implying that its performance aligns with those predicate devices, but no explicit acceptance criteria or detailed performance metrics are listed for the Innovacon Spectrum II Test Card itself.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not provided in the 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
Not applicable. This is a rapid immunoassay for qualitative detection of substances in urine, not an AI-assisted diagnostic imaging device that uses human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is a "standalone" test in the sense that it's a lateral flow immunoassay performed without an instrument, directly producing a visual result. However, it's not an algorithm, so the phrasing "algorithm only" doesn't quite fit. The document specifies, "These tests can be performed without the use of an instrument." The results are interpreted visually by a healthcare professional at point-of-care.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document states, "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) are the preferred confirmatory methods." This indicates that GC/MS would be the primary method for establishing ground truth/confirmation.
8. The sample size for the training set
Not provided in the document.
9. How the ground truth for the training set was established
Not provided in the document, but it's reasonable to infer that if a training set were used (which is typical for device development, though not explicitly mentioned here), the ground truth for it would also rely on confirmatory methods like GC/MS, consistent with item #7.
§ 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).