(170 days)
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No
The summary describes a standard in vitro diagnostic system for drug testing using enzyme immunoassays and enzymatic assays. There is no mention of AI, ML, or any related technologies in the intended use, device description, or other sections. The analysis relies on established chemical methods and requires confirmation by GC/MS.
No.
The device is an in vitro diagnostic device used for qualitative, semi-quantitative, and quantitative analysis of substances in human urine, which aids in diagnosis but does not provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The iMDx™ System is an in vitro diagnostic device" and also mentions that measurements are "used in the diagnosis and treatment of alcohol intoxication and poisoning."
No
The device description explicitly states that the iMDx™ System consists of both the "iMDx™ Analyzer" and "iMDxPrep™ Assays," indicating the presence of hardware components (the analyzer) and physical reagents (the assays), not just software.
Yes, the provided text explicitly states that the iMDx™ System is an in vitro diagnostic device.
This is mentioned in both the "Intended Use / Indications for Use" and "Device Description" sections.
N/A
Intended Use / Indications 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 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.
Product codes
DJG, DMT, JXM, DJR, DIO, DKB, JJE and DIF
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
practitioners in drug rehabilitation clinics, physician offices, and clinical laboratories. FOR USE BY TRAINED PERSONNEL ONLY. Only operators trained in the use of the iMDx™ System by NOVX personnel should perform these procedures.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird-like symbol, with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOVX Systems Inc. c/o Mr. Thomas Tsakeris Devices & Diagnostics Consulting Group Inc. 16809 Briardale Road Rockville, MD 20855
JUN - 1 2007
Re: K063699
Trade Name: iMDx™ System Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system. Regulatory Class: Class II Product Code: DJG, DMT, JXM, DJR, DIO, DKB, JJE and DIF
Dated: April 10, 2007 Received: April 11, 2007
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, permits your device to proceed to the market.
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-free number (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.
Jéan 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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Indications for Use
510(k) Number (if known):
Device Name:
Indications 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 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.
Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of In Vitro Diagnostic Devices
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety