Search Results

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.

Ask a specific question about this device

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 Opiates (Morphine), Benzodiazepine (Oxazepam) and Cocaine Metabolite (Benzoylecgonine) Assays are an enzyme immunoassav with a 300ng/mL cutoff. These assays are intended for use in the qualitative and semi-quantitative analysis of Opiates, Benzodiazepine and Cocaine Metabolite in human urine. The Methadone Metabolite (EDDP) Assay is an enzyme immunoassay with a 100ng/mL cutoff. The assay is intended for use in the qualitative and semi-quantitative analysis of Methadone Metabolite in human urine. For point of care use semi-quantitative analysis is only for estimation of dilution for confirmation testing.

The Ethyl Alcohol Assay is an enzymatic assay intended for use in quantitative analysis of ethyl alcohol in human urine. Measurements contained are used in the diagnosis and treatment of alcohol intoxication and poisoning.

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 operators 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 is a 510(k) premarket notification letter from the FDA to NOVX Systems Inc. regarding their iMDx™ System. It states that the device has been found substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information regarding acceptance criteria, study data, sample sizes, ground truth establishment, or expert qualifications. It is a regulatory approval letter, not a technical report detailing performance studies.

Therefore, I cannot provide the requested information from this document.

Ask a specific question about this device