(296 days)
The iMDx™ System is an in vitro diagnostic device consisting of iMDx™ Analyzer and iMDxPrep™ Assays. The system is an expandable, closed system. All assays are designed for use with automated iMDx™ Analyzer. The system has been designed to be used by practitioners in drug rehabilitation clinics, physician offices, and clinical laboratories.
The Amphetamines (Amphetamines and Methamphetamine), Oxycodone (Oxycodone), Phencyclidine (Phencyclidine) and Cannabinoids (A -THC-COOH) assays are enzyme immunoassays with cutoffs of 1000 ng/mL, 100ng/mL, 25 ng/mL and 50 ng/mL, respectively. These assays are intended for use in the qualitative and semi-quantitative analysis of Amphetamine, Oxycodone, Phencyclidine and Cannabinoids in human urine.
Semi-quantitative analysis is for the estimation of dilution for confirmation testing and to establish quality control procedures and assess quality control performance in general. Periodic calibration and use of control are required to maintain testing accuracy and assay performance.
All assays provide only a preliminary result. Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) analysis is performed. FOR USE BY TRAINED PERSONNEL ONLY. Only overators trained in the use of the iMDx™ System by NOVX personnel should perform these procedures.
The iMDx™ System is an in vitro diagnostic device consisting of iMDx™ Analyzer and iMDxPrep™ Assays. The system is an expandable, closed system. All assays are designed for use with automated iMDx™ Analyzer.
The provided text describes the 510(k) clearance for the iMDx System, an in vitro diagnostic device for drug testing. However, the document does not contain the detailed study information, acceptance criteria, or performance data that would allow for a comprehensive report as requested in your prompt.
Specifically, the document primarily focuses on the regulatory clearance for the device and its intended use, but it omits the following information essential for your request:
- Acceptance Criteria/Reported Device Performance Table: The document states the cutoffs for each assay but does not provide specific performance metrics (e.g., sensitivity, specificity, accuracy) against which acceptance criteria would be measured.
- Study Design Details: Information about sample sizes for test sets, training sets, data provenance, ground truth establishment methods, expert qualifications, adjudication methods, or results of MRMC studies is entirely absent.
- Standalone Performance: While the product is an IVD system, specific "standalone" performance metrics like algorithm-only accuracy are not reported.
Therefore, based solely on the provided text, I cannot fulfill your request for a detailed description of the acceptance criteria and the study that proves the device meets them. The document is a regulatory approval letter, not a scientific study report.
To provide the requested information, I would need a detailed study report or clinical validation data for the iMDx System, which is not present in the provided text.
§ 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).