PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS

{0}------------------------------------------------ ## DEC 1 5 2003 DEC 15 2003 K033306 page 1 of 3 | 510(k) Summary | | |-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. | | 1) Submitter name, address, contact | Roche Diagnostics Corporation 9115 Hague Rd. Indianapolis, IN 46250 (317) 521-7637 | | | Contact Person: Kerwin Kaufman Date Prepared: October 13, 2003 | | 2) Device name | Proprietary name: Preciset DAT Plus II and Cfas DAT Qualitative Plus Calibrators | | | Common name: Calibrators, Drug Mixture | | | Classification name: Clinical Toxicology Calibrator | | 3) Predicate devices | We claim substantial equivalence to the currently marketed Roche calibrators: | | | Abuscreen OnLine Preciset DAT I Calibrators, cleared in 510(k) K951595 (formerly Abuscreen OnLine Calibration Pack). | Continued on next page {1}------------------------------------------------ ## 510(k) Summary, Continued K033306 paje 2 of 3 Roche Preciset DAT Plus II calibrators contain a mixture of 2 different drugs, 4) Device propared by the quantitative addition of drug or drug metabolite to drug-free Description human urine. Drugs included are benzodiazepines and opiates. The calibrator set contains up to six levels for each drug contained in bottles 1-6. Bottle 1 is negative (drug free) human urine, followed by bottles 2-6 containing increasing amounts of each drug in a multi-analyte mixture. Drug or drug metabolite and their respective levels included are as follows: > Benzodiazepines: 0, 50, 100, 200, 400 ng/ml (no 6th level) Opiates: 0, 150, 300, 600, 1000, 2000 ng/ml Roche Cfas DAT Qualitative Plus calibrator contains a mixture of 7 different drugs, prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Drugs included are barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, and propoxyphene. The calibrator set contains a single level for each drug mixture. Drugs or drug metabolites and their respective levels included are as follows: Barbiturates: 200 ng/ml Benzodiazepines: 300 ng/ml Cocaine: 150 ng/ml Methadone: 300 ng/ml Opiates: 2000 ng/ml Phencyclidine: 25 ng/ml Propoxyphene: 300 ng/ml Continued on next page {2}------------------------------------------------ K033306 page 3 of 3 510(k) Summary, Continued | 5.) Intended Use | The Preciset DAT Plus II calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers. | |----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | The Cfas DAT Qualitative Plus calibrator is designed for the qualitative calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers. | | 6.) Comparison to the Predicate Device | The Roche Preciset DAT Plus II and Cfas DAT Qualitative Plus multianalyte calibrators are substantially equivalent to other products cleared for commercial distribution intended for similar use. Most notably, they are substantially equivalent to the currently marketed Roche Abuscreen OnLine Preciset DAT I multianalyte calibrators, manufactured for Roche Diagnostics and cleared in 510(k) submission K951595 by Roche Diagnostics. | | | The Preciset DAT Plus Il calibrators contain a mixture of 2 different drugs, prepared by the quantitative addition of drug or drug metabolite to drug-free human urine with added preservative. Drugs included are benzodiazepines and opiates. The calibrator set contains up to six levels for each drug. | | | The Cfas DAT Qualitative Plus calibrator contain a mixture of 7 different drugs, prepared by the quantitative addition of drug or drug metabolite to drug-free human urine with added preservative. Drugs included are barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, and propoxyphene. The calibrator contains only a single level of each drug. | | | The predicate device, Abuscreen OnLine Preciset DAT I calibrators contain a mixture of 9 different drugs, prepared by the quantitative addition of drug or drug metabolite to drug-free human urine with added preservatives and stabilizers. Drugs included are amphetamines, barbiturates, benzodiazepines, cocaine, methadone, methaqualone, opiates, phencyclidine, and propoxyphene. The calibrator set contains four levels for each drug. | » . 1 . {3}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three horizontal bars above it, representing the department's mission to protect the health of all Americans and provide essential human services. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 DEC 1 5 2003 Mr. Kerwin Kaufman Regulatory Affairs Consultant Roche Diagnostics Corporation 9115 Hague Road, P.O. Box 50457 Indianapolis, IN 46250-0457 Re: k033306 > Trade/Device Name: Roche Preciset DAT Plus II and Cfas DAT Qualitative Plus Calibrators Regulation Number: 21 CFR 862.3200 Regulation Name: Clinical toxicology calibrator Regulatory Class: Class II Product Code: DKB Dated: October 13, 2003 Received: October 14, 2003 Dear Mr. Kaufman: 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 Putman Steven 1. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## Indications for Use Statement | 510(k) Number (if known): | K033306 | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name: | Roche Preciset DAT Plus II and Cfas DAT Qualitative Plus Calibrators | | Indications for Use: | The Preciset DAT Plus II calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers. | | | The Cfas DAT Qualitative Plus calibrator is designed for the qualitative calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers. | (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) | <div style="display:inline-block;">X</div> OR Over-the-Counter Use ______ | |---------------------------------------|---------------------------------------------------------------------------| |---------------------------------------|---------------------------------------------------------------------------| (Optional format 1-2-96) Division Sign-Off for Jean Cooper Office of In Vitro Diagnostic Device Evaluation and Safety K033306 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ KO333 06 510(k) _______________________________________________________________________________________________________________________________________________________________________ : 上 :・・・