(126 days)
The Forsure One Step Single or Multiple (X) Drug Screen Strip of Amphetamine, Methamphetamine, Benzoylecgonine, Benzodiazepine, Marijuana, Morphine, Phencyclidine, Methadone , Oxycodone , Tricyclic Antidepressant, Barbiturates and Propoxyphene Test device are a Chromatographic immunoassay for qualitative determination of the presence of Amphetamine at a cutoff concentration of 1000 ng/ml, Methamphetamine at a cutoff concentration of 1000 ng/ml, THC at a cutoff concentration of 50 ng/ml, Morphine at a cutoff concentration of 2000 ng/ml, Benzoylecgonine at a cutoff concentration of 300 ng/ml . Phencyclidine at a cutoff concentration of 25 ng/ml, Benzodiazepine at cutoff concentration of 300 ng/ml, Methadone at cutoff concentration of 300 ng/ml, Oxycodone at cutoff concentration of 100 ng/ml, Tricyclic Antidepressant at cutoff concentration of 1000 ng/ml, Barbiturates at cutoff concentration of 300 ng/ml, and Propoxyphene at cutoff concentration of 300 ng/ml. The assay provides a simple and rapid analytical screening procedure to detect Amphetamine, THC, Morphine, Methamphetamine, Benzoylecognine, Phencyclidine, Benzodiazepine, Methadone , Oxycodone , Tricyclic Antidepressant, Barbiturates and Propoxyphene in human urine. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatogrphy/mass spectrometry (GC/MS) is the preferred confirmatory method.
New Bay Forsure Rapid One Step Single and Multiple(X) Abuse Drug Screen Test Cup Device consists of a or multiple chromatographic absorbent strip in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows through the absorbent strip, the Colloidal Gold labeled antibody- conjugate binds to the free drug in the specimen forming an antibody-antigen complex. This complex competes with immobilized antigen conjugate in the Test reaction zone and will not produce a magenta color band when the drug is above the detection level of 1000 ng/ml of Amphetamine,1000 ng/ml of Methamphetamine, 50 ng of THC, 2000ng/ml of Morphine,300 ng of Benzoylecognine , 25 ng/ml of Phencyclidine, 300 ng/ml of Benzodiazepine, 300 ng/ml of Methadone, 100 ng/ml of Oxycodone , 1000 ng/ml of Tricyclic Antidepressant, 300 ng/ml of Barbiturates and 300 ng/ml of Propoxyphene. Unbound colloidal gold-labeled antibody conjugate binds to the reagent in the negative control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. A NEGATIVE specimen produces two distinct color bands in both the specific drug test region and control area. A POSITIVE specimen produces only one color band in the control area and no color band on the specific drug test region . There is no meaning attributed to color or its intensity for either line. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
The provided text describes a medical device, the Forsure Rapid One Step Multiple(X) Abuse Drug Screen Test Cup Device, but does not include a study or data proving it meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices.
Therefore, many of the requested details cannot be extracted from the provided input.
Here's a breakdown of what can be inferred and what is missing:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" or present a table of device performance against such criteria. It lists cutoff concentrations for various drugs, which serve as a de facto performance threshold for the qualitative detection. However, it does not provide sensitivity, specificity, accuracy, or other performance metrics.
| Test | Analyte or Metabolite(s) to be Determined | Cut-off (ng/ml) (Implied Acceptance Criteria) | Reported Device Performance (Not Provided) |
|---|---|---|---|
| Amphetamine | D-Amphetamine | 1000 | Not provided |
| Methamphetamine | (+) Methamphetamine | 1000 | Not provided |
| Cocaine | Benzoylecgonine | 300 | Not provided |
| Cannabinoid | (-)11-nor-9-carboxy-delta 9 THC | 50 | Not provided |
| Opiate | Morphine | 2000 | Not provided |
| Benzodiazepine | Oxazepam | 300 | Not provided |
| Phencyclidine | Phencyclidine | 25 | Not provided |
| Methadone | (+/-) Methadone Hydrochloride | 300 | Not provided |
| Oxycodone | Oxycodone Hydrochloride | 100 | Not provided |
| Tricyclic Antidepressant | Nortriptyline Hydrochloride | 1000 | Not provided |
| Barbiturates | Secobarbital | 300 | Not provided |
| Propoxyphene | (+) Propoxyphene | 300 | Not provided |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The filing is a 510(k) summary focused on substantial equivalence to existing devices, not a detailed report of clinical study results.
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)
This information is not provided. The ground truth is established using a Gas Chromatography/Mass Spectrometry (GC/MS) system, which is a laboratory method, not human expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. The ground truth is established by GC/MS, not human interpretation requiring adjudication.
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
This is not applicable. The device is an immunoassay test cup for drug screening, which is visually read. There is no AI component or human reader interpretation in the context of an MRMC study described. The document states "None, Visual read single use" under instrumentation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a standalone immunoassay test that provides a visual reading. The performance described would inherently be "standalone" in that it produces a result without human interpretation of complex data. However, the document does not detail specific performance studies, only cut-off concentrations.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used for confirmation is Gas Chromatography/Mass Spectrometry (GC/MS). The document explicitly states: "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."
8. The sample size for the training set
This information is not provided. The document describes an immunoassay device, not an algorithm that would typically have a "training set" in the machine learning sense. If the question implicitly refers to samples used during the development or validation of the immunoassay, that data is not included.
9. How the ground truth for the training set was established
This information is not provided. As above, the concept of a "training set" is not directly applicable in the context of the provided information about this immunoassay device.
§ 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).