(56 days)
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No
The device description and intended use clearly state it is a chromatographic immunoassay providing visual, qualitative results. There is no mention of AI, ML, image processing, or any computational analysis beyond a simple chemical reaction and visual interpretation.
No
The document states that the devices are "in vitro screen tests" intended for "in vitro diagnostic use" for the detection of MDMA in urine, indicating they are diagnostic tools and not therapeutic devices.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The devices are intended for in vitro diagnostic use in professional and laboratory settings only."
No
The device is described as an in vitro diagnostic test using chromatographic immunoassays in a cassette or dipstick format, which are physical hardware components.
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicitly stated in the Intended Use: The text clearly states, "The devices are intended for in vitro diagnostic use in professional and laboratory settings only."
- Describes an in vitro test: The description mentions "in vitro screen tests that contains chromatographic immunoassays for the rapid detection of 3,4-Methylenedioxymethamphetamine (MDMA) in human urine." This describes a test performed outside of the body on a biological sample (urine).
- Identifies the sample type: The test is performed on "human urine."
- Specifies the analyte being detected: The test detects "3,4-Methylenedioxymethamphetamine (MDMA)."
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Monitect® MDMA Drug Screen Cassette Test and the Fastect™ II Drug Screen Dipstick Test are in vitro screen tests that contains chromatographic immunoassays for the rapid detection of 3,4-Methylenedioxymethamphetamine (MDMA) in human urine above the cutoff concentration of 500 ng/mL. Both the Monitect® and Fastect™ II devices provide visual, qualitative results only. The devices are intended for in vitro diagnostic use in professional and laboratory settings only. The devices are not intended for over-thecounter sale to lay persons. The assays provide only preliminary results. Clinical consideration and professional judgment must be applied to any drug of abuse 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. The Substance Abuse and Mental Health Services Administration (SAMHSA) has recognized Gas Chromatography/Mass Spectroscopy (GC/MS) as the preferred confirmatory method.
Product codes
DKZ
Device Description
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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
professional and laboratory settings only. The devices are not intended for over-thecounter sale to lay persons.
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized graphic of an abstract eagle or bird-like figure, composed of three curved lines that suggest wings or feathers.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 2 5 2004
Mr. Raphael Wong President Branan Medical Corp. 10015 Muirlands Rd., Suite E Irvine, CA 92618
Re: K040203
Trade/Device Name: Monitect® MDMA Drug Screen Cassette Test Fastect™ II MDMA Drug Screen Dipstick Test Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine Test System Regulatory Class: Class II Product Code: DKZ Dated: January 26, 2004 Received: February 2, 2004
Dear Mr. Wong:
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. Iisting 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 (301) 594-3084. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Radiological Health
Jean M. Cooper, MS, DVM.
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and
Enclosure
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Indications for Use
510(k) Number (if known): K040203 Device Name: Monitect® MDMA Drug Screen Cassette Test Fastect™ II MDMA Drug Screen Dipstick Test
Indications for Use:
The Monitect® MDMA Drug Screen Cassette Test and the Fastect™ II Drug Screen Dipstick Test are in vitro screen tests that contains chromatographic immunoassays for the rapid detection of 3,4-Methylenedioxymethamphetamine (MDMA) in human urine above the cutoff concentration of 500 ng/mL. Both the Monitect® and Fastect™ II devices provide visual, qualitative results only. The devices are intended for in vitro diagnostic use in professional and laboratory settings only. The devices are not intended for over-thecounter sale to lay persons.
The assays provide only preliminary results. Clinical consideration and professional judgment must be applied to any drug of abuse 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. The Substance Abuse and Mental Health Services Administration (SAMHSA) has recognized Gas Chromatography/Mass Spectroscopy (GC/MS) as the preferred confirmatory method.
Prescription Use Over-The-Counter Use × AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Albert Katz
Division Sian-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K040203
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