(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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
ය සිට මිල පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි මෙම පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි විසින් විසින් පිහිටි මෙයි. මෙය විසින් පිහිට
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Novx Systems, Inc. c/o Thomas Tsakeris, President, Devices and Diagnosis Consulting Group 16809 Briardale Road Rockville, MD 20853
OCT 3 1 2008
Re: K080057
Trade/Device Name: iMDx System Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Codes: DKZ, DLJ, DIF, LDJ, DJG, LCM Dated: October 22, 2008 Received: October 23, 2008
Dear Mr. Tsakeris:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permitte your device to proceed to the market.
র কার্যালয়ের সামনে সামাজের মাধ্যমে অন্যান্য করে আর কোনো না। এটি করে আর একটি নির্মাণ ক
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll the (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Jean M. Cooper, M.S., D.v.M.
Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
ート Lakes House La September 1974 - 12 - 11, 2016 - 12:50 - 12 - 12 - 12 - 32 - 32 - 32 - 32 - 32 - 32 - 32 - 32 - 32 - 32 - 32 - 32 - 32 - 32 - 32 - 32 - 32 - 32 - 32 - 32 -
510(k) Number: K080057
Device Name: iMDx System
Indication for Use:
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.
Prescription Use × (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K080057
§ 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).