RAPID DRUG SCREEN

{0}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle's perimeter. Public Health Service Food and Drug Administration 2098 Gaither Road Rockville MD 20850 American Bio Medica Corporation c/o Ms. Fran White Regulatory Consultant MDC Associates 163 Cabot Street Beverly, MA 01915 510(k) Number: K012159 Re: Trade/Device Name: Rapid Drug Screen™ Trade/Device Name: Rapid Drug Screen Regulation Number: 862.3100, 862.3250, 862.3650, 862.3170, 862.3170, Regulation Number: 862.3100, 862.3210 862.3610, 862.3910 JUL 2 5 2001 Regulatory Class: II Regulatory Class: 11 Product Code: DKZ, DIO, LDJ, DJG, DIS, JXM, DJC, LCM, LFI Dated: July 13, 2001 Received: July 17, 2001 Dear Ms. White: We have reviewed your Section 510(k) notification of intent to market the devices merketed in We have reviewed your Section 510(x) notificantially equivalent to devices marketed in above and we have determined the device is substantially of the Modicel Davice above and we nave determined the device is the enactment date of the Medical Device interstate commerce pror to May 20, 1978, the encordance with the provisions of the dayine, subject to Amendments, of to devices man have been receifice, market the device, subject to Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, of the Ast include Federal Food, Drug, and Cosmone Free (110). the general controls provisions of the Act. The general controls provisions proctine proctine argentiae, lobaling the general controls provisions of the Act. "The general vood manufacturing practice, labeling, requirembitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III) If your device is classified (sec above) and cuch additional controls. Existing major regulations (Premarket Approval), it may be subject to such additions, Title 21, Parts (Premarket Approval), it may be subject to suen actively Regulations, Title 21, Parts 800 to 895. affecting your device can be found in the Code of Federal Regulations, Title affecting your device can be found in the Ossumes compliance with the Cood Manufacturing A substantially equivalent actemination assummation (21 CFR Part 820) and that, through Practice Iol Medical Devices: "Sentral (Children) (FDA) will verify such periodic GMP Inspections, the I ood and Drog Namestion may result in regulatory action. In assumptions. Failure to comply with the GMP regulation may result wise in the Fed assumptions. Fallure to comply with the GMT regulation your device in the Federal addition, FDA may publish further announcemarket notification submission does not affect Register. Please note: this response to your premarket notification and the Register. Please note: this response to your printered 542 of the Act for devices under the any obligation you might have under becauses or other Federal laws or regulations. {1}------------------------------------------------ ## Page 2 This letter will allow you to begin marketing your device as described in your 510(k) prematket This letter will allow you to begin marketing your device to a legally marketed notification. The FDA finding of substantial equivalee of your device to notification. The FDA finding of substantial equivalence of 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 If you desire specific advice for your devices), please contact the Office of Compliance at additionally 809.10 for in vitto diagnostic devices), please contact the Office of additionally 809.10 for in vitto dagnostic nevestions on the promotion and advice, and device, and (301) 594-4588. Additionally, for questions on une promote the regulation please contact the Office of Compliance at (311) 594-4639. Also, please note the regulation please contact the Office of Compliance at (301) - 1037 - 1201 (FR 807.97). Other general entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Oth entitled, "Misbranding by reference of prematics (professor the Division of Small information on your responsibilities under the Act may be obtained from the Division of Smal information on your responsibilities under (800) 638-2041 or (301) 443-6597 or at its Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at Manufacturers Assistance at its ton tres collections and mamain.html". internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html". Sincerely yours, Steven Sutman Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Office of Dovices and Radiological Health Enclosure {2}------------------------------------------------ ## Special 510k Rapid Drug Screen Original 510 (k) number: K002447 American BioMedica Corporation Page 9 of 14 ## 510(k) Number: Kora 159 Device Name: Rapid Drug Screen™ Indication for Use: The ABM Rapid Drug Screen™ is for the determination of Cocaine, Triavelier, The ABM Rapid Drug Screen Trievelies, Mothemphetamine and Indication for Use: The ADM Rapid Driven Tricyclics, Methampletamine and Opiates, Marijuana, PCF, Barontales, Donzoulasspance, Barry, Qualitative results and is intended for professional use only. Fred Lacy (Division Sign-Off) (Division Sigil-On) Division of Clinical Laboratory Deviews K012159 510(k) Number . (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) OR Over The Counter Use (Optional Format 1-2-96)