ABUSCREEN ONLINE OPIATES 300 / 2000

{0}------------------------------------------------ ## 510(k) Summary K013482 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. Roche Diagnostics Corporation 1) Submitter name, address, 9115 Hague Rd. contact Indianapolis, IN 46250 (317) 521-7637 Contact Person: Kerwin Kaufman Date Prepared: October 18, 2001 Proprietary name: Abuscreen OnLine Opiates 300/2000 2) Device name Common name: Opiates Test System Classification name: Enzyme immunoassay, opiates 3) Predicate device We claim substantial equivalence to the currently marketed Abuscreen OnLine II Opiates 300/2000 assay (K974840). Continued on next page {1}------------------------------------------------ 4) Device Description The Abuscreen OnLine Opiates 300/2000 assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of morphine and its metabolites in human urine on automated clinical chemistry analyzers at cutoff concentrations of 300 and 2000 ng/mL #### Principal of procedure The Abuscreen OnLine Opiates 300/2000 assay is based on the kinetic interaction of microparticles in a solution (KIMS) as measured by changes in light transmission. In the absence of sample drug, soluble drug-polymer conjugates bind to antibody-bound microparticles, causing the formation of particle aggregates. When a urine sample containing the drug in question is present, this drug competes with the drug conjugate for microparticle-bound antibody. Antibody bound to sample drug is no longer available to promote particle aggregation, and subsequent particle lattice formation is inhibited. As the aggregation reaction proceeds in the absence of sample drug, the absorbance increases. Conversely, the presence of sample drug diminishes the increasing absorbance in proportion to the concentration of drug in the sample. Sample drug content is determined relative to the value obtained for a known cutoff concentration of drug. #### Negative Sample drug-polymer conjugate + antibody-bound microparticle = particle aggregates (↑ absorbance) #### Positive Sample sample drug + antibody-bound microparticle = particle aggregation inhibited drug-polymer conjugate + antibody bound microparticle = particle aggregates Continued on next page {2}------------------------------------------------ ### 510(k) Summary, Continued The Abuscreen OnLine Opiates 300/2000 assay is an in vitro diagnostic test 5.) Intended for the qualitative and semi-quantitative detection of morphine and its Use metabolites in buman urine on automated clinical chemistry analyzers at cutoff concentrations of 300 and 2000 ng/mL. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. 6.) Comparison to the Predicate Device The Roche Abuscreen OnLine Opiates 300/2000 assay is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Roche Abuscreen OnLine II Opiates 300/2000 (K974840). The Abuscreen OnLine Opiates 300/2000 assay utilizes the same reagent formulation as the currently marketed Abuscreen OnLine II Opiates 300/2000 assay (K974840). Differences between this application and the cleared assay include: - addition of a 300 ng/mL semi-quantitative cutoff claim, and ● - application to the Hitachi 900 series and Modular series of . analyzers. {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 depiction of an eagle or bird with three curved lines representing its body and wings. The bird is facing to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 DEC 2 1 2001 Mr. Kerwin Kaufman Regulatory Affairs Consultant Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457 Re: k013482 > Trade/Device Name: Roche Diagnostics Abuscreen OnLine Opiates 300/2000 Regulation Number: 21 CFR 862.3650 Regulation Name: Lead test system Regulatory Class: Class II Product Code: DJG Dated: October 18, 2001 Received: October 19, 2001 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 the Code 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 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 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 1 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/cdrb/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}------------------------------------------------ # Indications for Use Statement | 510(k) Number (if known): | K013482 | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name: | Roche Diagnostics Abuscreen OnLine Opiates 300/2000 | | Indications for Use: | An in vitro diagnostic test for the qualitative and semi-quantitative detection of morphine and its metabolites in human urine on automated clinical chemistry analyzers at cutoff concentrations of 300 and 2000 ng/mL. Semi- quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. | (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) | <span style="text-decoration: overline;">✓</span> OR Over-the-Counter Use ______ | |---------------------------------------|----------------------------------------------------------------------------------| | (Optional format 1-2-96) | | (Division Sign-Off) Division Clinical Laboratory Devices 510(k) Number: K013482 ______________________________________________________________________________________________________________________________________________________________________________