MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT II MDMA DRUG SCREEN DIPSTICK TEST, MODEL MF22

K040203 · Branan Medical Corp. · DKZ · Mar 25, 2004 · Clinical Toxicology

Device Facts

• Record ID: K040203
• Device Name: MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT II MDMA DRUG SCREEN DIPSTICK TEST, MODEL MF22
• Applicant: Branan Medical Corp.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Mar 25, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Intended Use

The devices are a one-step, visually read, lateral flow, immunochromatographic immunoassay for the qualitative detection of 3,4-methylenedioxymethamphetamine (MDMA) in human urine at concentrations above 500 ng/ml. The Monitect® MDMA Drug Screen Cassette Test is an in vitro screening device and is intended for professional use only. The test is not intended for over-the-counter sale to non-professionals.

Device Story

Lateral flow immunochromatographic assay for qualitative MDMA detection in human urine. Input: urine sample (via cassette or dipstick). Principle: competitive immunoassay; drug in sample competes with immobilized drug conjugate for limited antibody-colloidal gold binding sites. Output: visual color band (absence of band at test region indicates positive; presence indicates negative). Used in professional settings; operated by clinical staff. Provides preliminary screening results; requires GC/MS confirmation for clinical decision-making. Benefits: rapid, point-of-care screening for MDMA presence.

Clinical Evidence

No clinical data provided; device relies on analytical performance characteristics for in vitro diagnostic screening.

Technological Characteristics

Lateral flow immunochromatographic assay. Components: membrane strip, drug conjugate, monoclonal mouse anti-MDMA antibody-colloidal gold conjugate, goat anti-rabbit control antibody. Formats: cassette (3 drops) or dipstick (10-second immersion). Read time: 3-5 minutes. Qualitative visual readout. No external instrumentation required.

Indications for Use

Indicated for the rapid, qualitative, in vitro screening of human urine for 3,4-Methylenedioxymethamphetamine (MDMA) at a cutoff concentration of 500 ng/mL. Intended for professional and laboratory use only; not for over-the-counter sale.

Regulatory Classification

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.

Special Controls

*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).

Submission Summary (Full Text)

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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 [phone]. 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 [phone] or [phone] 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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