LIFESIGN COCAINE, MARIJUANA (THC), LIFESIGN DOA2 (THC/COC), STATUS STIK THC/COC, ACCUSIGN STIK THC/COC, ACCUSTIK THC/COC

{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: KO 14067 1. Date of Summary: Nov.30, 2001 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 3. Device Name Trade Names: LifeSign® Home Drug Test, Marijuana & Cocaine (THC/COC) Common or Usual Name: Immunoassay for detection of THC and cocaine in human urine Classification Name: Drugs of Abuse Analysis Systems, Toxicology (91DKE, 91DIO for Enzyme Immunoassay) - 4. Identification of legally marketed device to which claims equivalence: k990786; Status DS ™ DOA10(MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP) - 5. Device Description: LifeSign® Home Drug Test (THC/COC) is simple one step immunochromatographic test for the rapid, qualitative detection of THC and cocaine. - 6. Intended Use: LifeSign® Home Drug Test (THC/COC) is designed for the qualitative detection of THC metabolite, 11-nor-A-THC-9-carboxylic acid, at the cutoff of 50 ng/mL and cocaine metabolite, benzoylecgonine, at the cutoff of 300 ng/mL in human urine to assist in screening of drugs of abuse samples. For In vitro Diagnostic Use. - 7. Substantial Equivalence: LifeSign® Home Drug Test (THC/COC) is substantially equivalent to-k990786; Status DS™ DOA10. Both products use the same assay principle and immunochromatographic assay to detect THC and cocaine qualitatively. The detection cutoff levels are the same. The tests demonstrate 100 % correlation when 100 specimens (50 negative and 50 positive) for each drug were compared respectively. The difference is that LifeSign® Home Drug Test (THC/COC) detects THC and cocaine only, while Status DS™ DOA10 detects six other drugs of abuse in addition to THC and cocaine. The two devices use the same antibody for THC test, but different antibody for COC test. - 8. Consumer Study: In a consumer study, LifeSign® Home Drug Test (THC/COC) showed over 96% overall accuracy. {1}------------------------------------------------ . Conclusion: The device is substantially equivalent to the legally marketed device k990786, -- {2}------------------------------------------------ ## 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: 14067 - 1. Date of Summary: Nov.30, 2001 Princeton BioMeditech Corperation 2. Submitted by: 4242 U.S. Route 1, Monmouth Jct., NJ 08852 PHONE 732-274-1000 FAX 732-274-1010 Contact Person: Jemo Kang - 3. Device Name Trade Names: Stick: Status Stik™ THC/COC, AccuSign®Stik THC/COC, AccuStik™ THC/COC Card: AccuSign® THC/COC, Status DSTM THC/COC Strip: AccuStrip™ THC/COC Common or Usual Name: Immunoassay for detection of THC and cocaine in human urine Classification Name: Drugs of Abuse Analysis Systems, Toxicology (91DKE, 91DIO for Enzyme Immunoassay) - 4. Identification of legally marketed device to which claims equivalence: k990786: Status DS ™ DOA10(MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP) = - Stik™ Status 5. Device Description: THC/COC is simple one sten immunochromatographic test for the rapid, qualitative detection of THC and cocaine. - 6. Intended Use: Status Stik™ THC/COC is designed for the qualitative detection of THC metabolite, 11-nor-A2-THC-9-carboxylic acid, at the cutoff of 50 ng/mL and cocaine metabolite, benzoylecgonine, at the cutoff of 300 ng/mL in human urine to assist in screening of drugs of abuse samples. For In vitro Diagnostic Use. - 7. Substantial Equivalence: Status Stik™ THC/COC is substantially equivalent to k990786; Status DS™ DOA10. Both products use the same assay principle and immunochromatographic assay to detect THC and cocaine qualitatively. The detection cutoff levels are the same. The tests demonstrate 100 % correlation when 100 specimens (50 negative and 50 positive) for each drug were compared respectively. The difference is that Status Stik™ THC/COC detects THC and cocaine only, while Status DS™ DOA10 detects six other drugs of abuse in addition to THC and cocaine. The two devices use the same antibody for THC test, but different antibody for COC test. - Conclusion: The device is substantially equivalent to the legally marketed device k990786, Status DS™ DOA10 (MET/OPI/COC/THC/PCP/BZO/ BAR/MTD/TCA/AMP). {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Jemo Kang, Ph.D. Director Princeton BioMeditech Corporation 4242 U.S. Route 1 Moninouth Junction, NJ 08852-1905 Re: k014067 Trade/Device Name: LifeSign®Home Drug Test (THC/COC) Status Stik™ THC/COC. AccuSign®Stik THC/COC. AccuStik™ THC/COC. AccuSign® THC/COC, Status DSTM THC/COC, Strip: AccuStrip™ THC/COC Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: Class II Product Code: LDJ; DIO Dated: April 9, 2002 Received: April 10, 2002 JUN 1 0 2002 Dear Dr. Kang: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced abo and have determined the device is substantially equivalent (for the indications for use stated in the enclosur to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactmen 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 registrati 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 the CC of Federal Regulations, Title 21, Parts 800 to 898. 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 made a determination that your device complies with other requirements of the Act or any Federal statutes 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFF 1000-1050. {4}------------------------------------------------ Page 2 - This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 Butman Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Page · of 510(k) Number (if known): Ko I Hole J Device Name: LifeSign®Home Drug Test, Marijuana & Cocaine(THC/COC) Indications For Use: Immunoassay for the qualitative detection of THC metabolite, 11-nor-A-THC-9carboxylic acid, at the cut-off of 50 ng/mL and cocaine metabolite, benzoylecgonine, at the cut-off of 300 ng/mL in urine to assist in screening of drugs of abuse samples at home. For In vitro Diagnostic Use Pan (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number K014067 (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: (Per 21 CFR 801.109) OR Over The Counter Use: _X (Optional Format 1-2-96) {6}------------------------------------------------ Page **_ of _** Koluob7 510(k) Number (if known): -- Device Name: Stick: Status Stik™ THC/COC, AccuSign®Stik THC/COC, AccuStik™ THC/COC Card: AccuSign® THC/COC, Status DS™ THC/COC Strip: AccuStrip™ THC/COC Indications For Use: Immunoassay for the qualitative detection of THC metabolite, 11-nor-A-THC-9carboxylic acid, at the cut-off of 50 ng/mL and cocaine metabolite, benzoylecgonine, at the cut-off of 300 ng/mL in urine to assist in screening of drugs of abuse samples. For In vitro Diagnostic Use Han Cooger (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number K014067 (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) OR Over The Counter Use: (Optional Format 1-2-96)