LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, ACCUSIGN STIK MET & MDMA, ACCUSTIK MET & MDMA

{0}------------------------------------------------ #### 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR Part 807.92. The assigned 510(k) number is: Ko223837 Date of Summary: Nov. 14, 2002 1. - 2. Submitted by: Princeton BioMeditech Corporation 4242 U.S. Route 1, Monmouth Jct., NJ 08852 PHONE 732-274-1000 FAX 732-274-1010 Contact Person: Jemo Kang, Ph.D., Director 3. Device Name Trade Names: Stick: Status Stik™ THC/OPI/COC/MET & MDMA, AccuSign Stik THC/OPI/COC/MET & MDMA, AccuStik™ DOA4 Card: AccuSign® DOA4, Status DSTM DOA4 Strip: AccuStrip™ DOA4 Common or Usual Name: Immunoassay for detection of THC, opiates, cocaine, and methamphetamine, 3,4-methylenedioxymethamphetamine (MDMA) in urine Classification Name: Drugs of Abuse Analysis Systems, Toxicology (91DKE, 91DJG, 91DIO for Enzyme Immunoassay, 91LAG for HPLC) - 4. Identification of legally marketed device to which claims equivalence: Status Stik™ THC/OPI/COC/MET; k014193 - 5. Device Description: Status Stik™ THC/OPV/COC/MET & MDMA is simple one step immunochromatographic test for the rapid, qualitative, simultaneous detection of THC, opiates, cocaine, methamphetamine and 3,4-methylenedioxymethamph- etamine. - 6. Intended Use: Status Stik™ THC/OPI/COC/MET & MDMA is designed for the qualitative detection of THC at the cutoff of 50 ng/mL 11-nor-A-THC-9-carboxylic acid. opiates at the cutoff of 2000 ng/mL morphine, cocaine at the cutoff of 300 ng/mL benzoylecgonine, and methamphetamine and MDMA at the cutoff of 500 ng/mL d-methamphetamine and MDMA in human urine to assist in screening of drugs of abuse samples. For in vitro Diagnostic Use. This test provides only a preliminary analytical result and a more specific alternative chemical method must be used to obtain a confirmed analytical result and that GC/MS is the preferred confirmatory method. - 7. Substantial Equivalence: Status Stik™ THC/OPI/COC/MET & MDMA is substantially equivalent to the k014193. Status Stik™ THC/OPI/COC/MET. Both products use the same assay principle and are immunochromatographic assays to detect THC, opiates, cocaine, methamphetamine qualitatively. The difference is that Status Stik™ THC/OPI/COC/MET detects methamphetamine at 1000 ng/mL and MDMA at 2000 ng/mL, while Status StikTM THC/OPI/COC/MET & MDMA detects both methamphetamine and MDMA at 500 ng/mL. - Conclusion: The device is substantially equivalent to the legally marketed device, k014193, Status Stik™ THC/OPI/COC/MET. {1}------------------------------------------------ # 510(k) Summarv This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR Part 807.92. The assigned 510(k) number is: - 1. Date of Summary: Nov 15. 2002 - Princeton BioMeditech Corporation 2. Submitted by: 4242 U.S. Route 1, Monmouth Jct., NJ 08852 PHONE 732-274-1000 FAX 732-274-1010 Contact Person: Jemo Kang, Ph.D., Director - 3. Device Name Trade Names: LifeSign® Home Drug Test (Marijuana/Opiates/Cocaine/Ecstasy & MET) Common or Usual Name: Immunoassay for detection of THC, opiates, cocaine, > methamphetamine and 3,4-methlyenedioxymethamphetamine (MDMA) in urine Classification Name: Drugs of Abuse Analysis Systems, Toxicology (91DKE, 91DJG, 91DIO for Enzyme Immunoassay, 91LAG for HPLC) - 4. Identification of legally marketed device to which claims equivalence: LifeSign® Home Drug Test (THC/OPI/COC/MET): k014193 - 5. Device Description: LifeSign® Home Drug Test (Marijuana/Opiates/Cocaine/Ecstasy & MET) is simple one step immunochromatographic test for the rapid, qualitative, simultaneous detection of THC, opiates, cocaine, methamphetamine, and 3,4-methylenedioxymethamphetamine. - 6. Intended Use: LifeSign® Home Drug Test is designed for the qualitative detection of THC at the cutoff of 50 ng/mL 11-nor-d'-THC-9-carboxvlic acid, opiates at the cutoff of 2000 ng/mL morphine, cocaine at the cutoff of 300 ng/mL benzoylecgonine, methamphetamine and MDMA at the cutoff of 500 ng/mL d-methamphetamine and MDMA in human urine to assist in screening of drugs of abuse samples. For in vitro Diagnostic Use. This test is intended for use in the home to assist in preventing drug abuse. This test provides only a preliminary analytical result and a more specific alternative chemical method must be used to obtain a confirmed analytical result and that GC/MS is the preferred confirmatory method. - 7. Substantial Equivalence: LifeSign® Home Drug Test (Marijuana/Opiates/Cocaine/Ecstasy) is substantially equivalent to to the k014193, LifeSign® Home -Drug Test (THC/OPI/COC/MET). Both products use the same assay principle and are immunochromatographic assays to detect THC, opiates, cocaine, methamphetamine qualitatively. The difference is that LifeSign® Home Drug Test (THC/OPI/COC/MET) detects methamphetamine at 1000 ng/mL and MDMA at 2000 ng/mL, while LifeSign® Home Drug Test (Marijuana/Opiates/Cocaine/Ecstasy & & MET) detects both methamphetamine and MDMA at 500 ng/mL. {2}------------------------------------------------ - 8. Consumer Study: In a consumer study, LifeSign® Home Drug Test (THC/OPI/ COC/ MET) showed over 95% overall accuracy. Since LifeSign® Home Drug Test (Marijuana/Opiates/Cocaine/Ecstasy) is the same test (principle, format, test protocol, the reading of test result etc.) except the antibody used for methamphetamine, no new consumer study was performed. - Conclusion: The device is substantially equivalent to the legally marketed device, k014193, LifeSign® Home Drug Test (Marijuana/Opiates/Cocaine/Ecstasy & MET). The product is safe in the hands of the lay user. {3}------------------------------------------------ ## 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR Part 807.92. The assigned 510(k) number is:_ につつる8 37 1. Date of Summary: Nov. 14, 2002 - Princeton BioMeditech Corporation 2. Submitted by: 4242 U.S. Route 1. Monmouth Jct., NJ 08852 - PHONE 732-274-1000 FAX 732-274-1010 Contact Person: Jemo Kang, Ph.D. - 3. Device Name: Trade Names: Stick Device: Status Stik™ MET & MDMA, AccuSign® Stik MET & MDMA, AccuStik" MET & MDMA Card Device: AccuSign® MET & MDMA, Status DS™ MET & MDMA Strip Test: AccuStrip™ MET & MDMA Common or Usual Name: Immunoassay for detection of methamphetamine and 3,4-Methylenedioxymethamphetamine (MDMA) in urine Classification Name: Drugs of Abuse Analysis Systems, Toxicology (91LAG for HPLC) - 4. Identification of legally marketed device to which claims equivalence: k014092; Status Stik™ MET - 5. Device Description: Status Stik" MET & MDMA is simple one step immunochromatographic test for the rapid, qualitative detection methamphetamine and MDMA. - 6. Intended Use: Status Stik""MET & MDMA is designed for the qualitative detection of both methamphetamine and MDMA at the cutoff of 500 ng/mL in urine to assist in screening of drugs of abuse samples. For In vitro Diagnostic, Prescription Use. This test provides only a preliminary analytical result and a more specific alternative chemical method must be used to obtain a confirmed analytical result and that GC/MS is the preferred confirmatory method. - 7. Substantial Equivalence: Status Stik™ MET & MDMA is substantially equivalent to the k014092, Status Stik™ MET. Both products use the same assay principle and immunochromatographic assay to detect methamphetamine qualitatively. The difference is that Status Stik"" MET detects methamphetamine at 1000 ng/ml and MDMA at 2000 ng/ml, while Status DS™ MET & MDMA detects both methamphetamine and MDMA at 500 ng/ml. Conclusion: The device is substantially equivalent to a legally marketed device k014092, {4}------------------------------------------------ # 510(k) Summarv This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR Part 807.92. The assigned 510(k) number is: 16023832 - 1. Date of Summary: Nov. 14, 2002 - 2. Submitted by: Princeton BioMeditech Corporation 4242 U.S. Route 1, Monmouth Jct., NJ 08852 PHONE 732-274-1000 FAX 732-274-1010 Contact Person: Jemo Kang, Ph.D. - 3. Device Name: Trade Names: Life Sign® Home Drug Test (Ecstasy & MET) Common or Usual Name: Immunoassay for detection of methamphetamine and methylenedioxymethamphetamine (MDMA) in urine Classification Name: Drugs of Abuse Analysis Systems, Toxicology (91LAG for HPLC) - 4. Identification of legally marketed device to which claims equivalence: k014192 Life Sign® Home Drug Test (MET) - 5. Device Description: Life Sign® Home Drug Test (Ecstasy & MET) is simple one step immunochromatographic test for the rapid, qualitative detection of methamphetamine and MDMA. - Intended Use: Life Sign® Home Drug Test (Ecstasy & MET) is designed for the 6. qualitative detection of MDMA and methamphetamine at the cutoff of 500 ng/mL in urine to assist in screening of drugs of abuse samples at home or work place. For In vitro Diagnostic Use This test provides only a preliminary analytical result and a more specific alternative chemical method must be used to obtain a confirmed analytical result and that GC/MS is the preferred confirmatory method. - Substantial Equivalence: Life Sign® Home Drug Test (Ecstasy & MET) is substantially 7. equivalent to the k0140192; Life Sign® Home Drug Test (MET). Both products use the same assay principle and immunochromatographic assay to detect methamphetamine qualitatively. The difference is that Life Sign® Home Drug Test (MET) detects methamphetamine at 1000 ng/ml and MDMA at 2000 ng/ml, while Life Sign® Home Drug Test (Ecstasy & MET) detects both methamphetamine and MDMA at 500 ng/ml. - 8. Consumer Study: In a consumer study, LifeSign® Home Drug Test (MET) showed over 96% overall accuracy. Since LifeSign® Home Drug Test (Ecstasy & MET) is the same test (principle, format, test protocol, the reading of test result etc.) except the antibody used for methamphetamine, no new consumer study was performed. - Conclusion: The device is substantially equivalent to a legally marketed device k0140192, LifeSign® Home Drug Test (MET). {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three intertwined strands and a wavy base. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a circular arrangement. Public Health Service Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Jemo Kang, Ph.D., M.B.A. Director Princeton BioMeditech Corporation 4242 U.S. Route 1 Monmouth Junction, NJ 08852-1905 Re: k023837 Trade/Device Name: Status Stik™ THC/OPI/COC/MET & MDMA, AccuSign® Stik THC/OPI/COC/MET & MDMA, AccuStik® DOA 4, Status DSTM DOA 4, AccuSign® DOA 4, AccuStripTM DOA 4 Status Stik™ MET & MDMA, AccuSign® Stik MET & MDMA, AccuStik® MET & MDMA, AccuSign® MET & MDMA, Status DSTM MET & MDMA, AccuStrip™ MET & MDMA LifeSign®Home Drug Test (Ecstasy/MET) LifeSign Home Drug Test (Marijuana/Opiates/Cocaine/Ecstasy & MET) Regulation Number: - 21 CFR 862.3610 Regulation Name: Methamphetamine test system Regulatory Class: Class II Product Code: LAF; LDJ; DJG; DIO Dated: June 19, 2003 Received: June 19, 2003 SEP 1 5 2003 Dear Dr. Kang: 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. {6}------------------------------------------------ #### Page 2 - 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). 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 {7}------------------------------------------------ Page Page 2 of 510(k) Number (if known): Device Name: Status Stik™ MET & MDMA, AccuSign®Stik MET & MDMA, AccuStik™ MET & MDMA, AccuSign® MET & MDMA, Status DS™ MET & MDMA, AccuStrip™ MET & MDMA Indications For Use: Immunoassay for the qualitative detection of methamphetamine and 3,4-methylenedioxymethamphetamine (MDMA) at the cut-off of 500 ng/mL in urine to assist in screening of drugs of abuse samples. For In vitro Diagnostic Use This test provides only a preliminary analytical result and a more specific alternative chemical method must be used to obtain a confirmed analytical result and that GC/MS is the preferred confirmatory method. Trade Names for each format Stick: Status Stik™ MET & MDMA, AccuSign®Stik MET & MDMA, AccuStik™ MET & MDMA Card: AccuSign® MET & MDMA, Status DS™ MET & MDMA Strip: AccuStrip™ MET & MDMA (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE) | Professional Use: | | |----------------------|---| | Prescription Use: | X | | (Per 21 CFR 801.109) | | Division Sign-Off for Jean Cooper Office of In Vitro Di 4 ffice of In Vitro Diagnostic Device ( Evaluation and Safety 510(k) K023837 Over The Counter Use: __ (Optional Format 1-2-96) {8}------------------------------------------------ Page of # 14023837 ## Device Name: Status Stik™ THC/OPI/COC/MET & MDMA, AccuSign® Stik THC/OPI/COC/MET & MDMA, AccuStik®DOA 4, Status DS™ DOA 4, AccuSign® DOA 4 Indications For Use: 510(k) Number (if known): Immunoassay for the qualitative detection of THC metabolite, opiates, cocaine metabolite, methamphetamine and 3,4-methylenedioxymethamphetamine in urine to assist in screening of drugs of abuse. For in vitro Diagnostic Use The detection cutoff concentrations are as follows: | THC | 11-nor-Δ 9-THC-9-carboxylic acid | 50 ng/ mL | |------|-----------------------------------|-------------| | OPI | Morphine | 2000 ng/ mL | | COC | Benzoylecgonine | 300 ng/ mL | | MET | D-Methamphetamine | 500 ng/ mL | | MDMA | 3,4-Methylenedioxymethamphetamine | 500 ng/ mL | This test provides only a preliminary analytical result and a more specific alternative chemical method must be used to obtain a confirmed analytical result and that GC/MS is the preferred confirmatory method. Trade Names for each device format Stick: Status Stik™ THC/OPI/COC/MET & MDMA, AccuSign®Stik THC/OPI/COC/MET & MDMA, AccuStik™ DOA4 Card: AccuSign® DOA4, Status DSTM DOA4 Strip: AccuStrip™ DOA4 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE) 4 Professional Use: Prescription Use: X OR Over The Counter Use: (Per 21 CFR 801.109) Albert Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) k023837 (Optional Format 1-2-96) {9}------------------------------------------------ Page of 510(k) Number (if known): Ko23837 Device Name:_ LifeSign®Home Drug Test ( Ecstasy/MET) Indications For Use: the the qualitative detection of methamphetamine Immunoassay for and 3,4methylenedioxymethamphetamine (MDMA) at the cut-off of 500 ng/mL in urine to assist in screening of drugs of abuse samples at home and work place. For In vitro Diagnostic Use This test provides only a preliminary analytical result and a more specific alternative chemical method must be used to obtain a confirmed analytical result and that GC/MS is the preferred confirmatory method. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE) Professional Use: **__** Prescription Use:**__** OR (Per 21 CFR 801.109) Division Sign-Off for Jean Cooper Office of In Vitro Diagnostic Device 5 Evaluation and Safety Over The Counter Use: X (Optional Format 1-2-96) 510(k) k023837 {10}------------------------------------------------ Page of 510(k) Number (if known): Device Name: LifeSign® Home Drug Test (Marijuana/Opiates/Cocaine/Ecstasy & MET) Indications for Use: Immunoassay for the qualitative detection of THC metabolite, opiates, cocaine metabolite, methamphetamine and 3,4-methylenedioxymethamphetamine in urine to assist in screening of drugs of abuse samples at home or work places. For in vitro Diagnostic Use. The detection cutoff concentrations are as follows: | THC | 11-nor-Δ⁹-THC-9-carboxylic acid | 50 ng/mL | |------|-----------------------------------|------------| | OPI | Morphine | 2000 ng/mL | | COC | Benzoylecgonine | 300 ng/mL | | MET | D-Methamphetamine | 500 ng/mL | | MDMA | 3,4-methylenedioxymethamphetamine | 500 ng/mL | This test provides only a preliminary analytical result and a more specific alternative chemical method must be used to obtain a confirmed analytical result and that GC/MS is the preferred confirmatory method. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE) Professional Use:_ Prescription Use: OR Over The Counter Use: X (Optional Format 1-2-96) (Per 21 CFR 801.109) Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) k0209837 5