STARTOX DRUG OF ABUSE SCREENING TEST (4)

{0}------------------------------------------------ FEB 2 7 2003 # 510 (K) SUMMARY Date of Summary: 2-17-03 ## Product Name: STARTOX (4) ### Sponsor: Starplex Scientific, Inc. 50 Steinway Blvd. Etobicoke, Ontario, Canada M9W 6Y3 #### Correspondent: Fran White MDC Associates 163 Cabot Street Beverly, MA 01915 ### Substantially Equivalent Devices: Product: Rapid Drug Screen - 9 panel Manufactured by: American BioMedica Corp K Number: K012159 ## PRODUCT DESCRIPTION: A lateral flow immunoassay for the detection of drugs of abuse. {1}------------------------------------------------ #### INTENDED USE: "STARTOX" Drugs of Abuse Screening Test is a one-step lateral flow immunoassay intended for the simultaneous detection of multiple drug analytes in urine. "STARTOX" is intended for use in the qualitative detection of drugs of abuse at the following Substance Abuse Mental Health Services Administration (SAMHSA) recommended levels: | Compound | Abbreviation | Level | |---------------------------------------------------|--------------|------------| | Methamphetamine ((+/-)methamphetamine HCl) | METH | 1000 ng/ml | | Opiates (morphine) | OPI | 300 ng/ml | | Cocaine (benzoylecgonine) | COC | 300 ng/ml | | Cannabinoids<br>(11-nor-Δ9-THC-9-carboxylic-acid) | THC | 50 ng/ml | STARTOX™ Drugs of Abuse Screening Test provide only a preliminary qualitative test result. Use a more specific alternate quantitative analytical method to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Apply clinical and professional judgment to any drug of abuse test result, particularly when preliminary positive results are obtained. #### PERFORMANCE CHARACTERISTICS: STARTOX™ drugs of abuse screening test detects 4 drugs in human urine at the levels indicated. STARTOX™ is substantial equivalent to Rapid Drug Screen 9 panel manufactured by American BioMedica Corporation 510k number K002447. Product performance for Opiates, Cocaine and Cannabinoids was compared Medtox Profile II manufactured by Medtox Diagnostics. Performance of Methamphetamine was compared to RDS 9 manufactured by American BioMedica, Inc. Ninety (90) samples were tested against each drug, 50 negative and 40 positive specimens. Drug status of these samples was tested by EMIT and quantified by GC/MS. The STARTOX™ Drugs of Abuse Screening Test was compared to a FDA substantially equivalent approved device. STARTOX™ performed substantially equivalent to the legally marketed device. Reproducibility was evaluated using control urines containing drug concentrations above and below the stated cut-off. Negative controls were also tested. The results confirmed the reproducibility of the STARTOX™ Drugs of Abuse Screening Test. {2}------------------------------------------------ #### CONCLUSION: STARTOX™ Drug of Abuse Screening Test is substantially equivalent to ABMC Rapid Drug Screen multi-drug products (K012159, K002447) previously cleared for market as demonstrated by the results obtained in the studies. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 # FEB 2 7 2003 Starplex Scientific, Inc. c/o Ms. Fran White Regulatory Consultant MDC Associates 163 Cabot Street Beverly, MA 01915 Re: k022388 Trade/Device Name: Startox Drug of Abuse Screening Test Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine test system Regulatory Class: Class II Product Code: DJC; DJG; DJG; LDJ Dated: December 4, 2002 Received: December 6, 2002 Dear Ms. White: 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). {4}------------------------------------------------ Page 2 - 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, Steven Sutman Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ #### 510(K) NUMBER: K022388 #### Device Name: STARTOX Drug of Abuse Screening Test #### Indication for Use: "STARTOX" Drugs of Abuse Screening Test is a one-step lateral flow immunoassay intended for the simultaneous detection of multiple drug analytes in urine. "STARTOX" is intended for use in the qualitative detection of drugs of abuse at the following Substance Abuse Mental Health Services Administration (SAMHSA) recommended levels: | Compound | Abbreviation | Level | |---------------------------------------------------|--------------|------------| | Methamphetamine ((+/-)methamphetamine HCl) | METH | 1000 ng/ml | | Opiates (morphine) | OPIATES | 300 ng/ml | | Cocaine (benzoylecgonine) | COCAINE | 300 ng/ml | | Cannabinoids<br>(11-nor-Δ9-THC-9-carboxylic-acid) | THC | 50 ng/ml | STARTOX™ Drugs of Abuse Screening Test provide only a preliminary qualitative test result. Use a more specific alternate quantitative analytical method to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Apply clinical and professional judgment to any drug of abuse test result, particularly when preliminary positive results are obtained. For professional use only. Cooger (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number K022388 (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ## Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use | ✓ | |----------------------|---| | (Per 21 CFR 801.109) | | OROver The Counter Use (Optional Format 1-2-96)