MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES

{0}------------------------------------------------ ## 1983699 # Roche ### DEC 1 1 1998 ## 510(k) Summary ## Abuscreen ONLINE® Amphetamines In accordance with the Safe Medical Devices Act of 1990, a 510(k) summary is provided as outlined in 21 CFR 807.92. The assigned 510(k) number is: #### Identification of 510(k) Sponsor: I. Roche Diagnostic Systems, Inc. a subsidiary of Hoffmann-La Roche, Inc. Branchburg Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771 510(k) Submission dated October 20 , 1998 Rita Smith Contact: Senior Regulatory Affairs Associate Phone: (908) 253-7545 Fax: (908) 253-7547 Branchburg Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771 {1}------------------------------------------------ #### II. Device Name: ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ The device name, including both the trade/proprietary name and the classification name are provided in the table below. | Product Name | Classification<br>Name | Product<br>Code | CFR<br>Number and<br>Regulatory Class | |--------------------------------------|------------------------------------|-----------------|---------------------------------------| | Abuscreen ONLINE for<br>Amphetamines | Enzyme Immunoassay,<br>Amphetamine | DKZ | 862.3100<br>Class II | #### Identification of the legally marketed device to which the 510(k) sponsor claims III. equivalence: The following table identifies the legally marketed device to which Roche Diagnostic Systems, Inc. claims equivalence. : 中国 . | T<br>able | y | |-----------|---| |-----------|---| | Product Name | Predicate Product Name | 510(k) Number and Date<br>Predicate Cleared | |--------------------------------------|--------------------------------------|---------------------------------------------| | Abuscreen ONLINE for<br>Amphetamines | Abuscreen ONLINE for<br>Amphetamines | K933052 9/15/93 | {2}------------------------------------------------ #### Description of the Device/Statement of Intended Use: IV. Abuscreen ONLINE Amphetamines is an in vitro diagnostic test for the qualitative and semiquantitative detection of amphetamine and methamphetamine and their metabolites in human urine on automated clinical chemistry analyzers at a cutoff of 1000 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of amphetamine use or abuse. The proposed Abuscreen ONLINE Amphetamines test kit is specifically intended for use on the Hitachi 917 Analyzer and future similar analyzer models. It was adapted from the currently marketed Abuscreen ONLINE Amphetamines test kit. The reagent compositions are the same as the previously cleared Abuscreen ONLINE Amphetamines kit; although the labeling and packaging have been modified for use on the Hitachi 917 Analyzer. This modified test kit is not a replacement to the currently marketed kit. The Hitachi 917 Analyzer System is a fully automatic, computer-controlled system for clinical chemistry. It was conceived for both quantitative and qualitative in vitro determination using a large variety of tests for analysis, e.g. in serum and urine. Integrated in the system is an ion-selective unit for determination of electrolytes. The throughput per hour is 800 tests for clinical chemistry (1200 with electrolytes). The system consists of the analyzer which performs all functions required for fully automatic sample and test processing. Beginning with the automatic recording of patient samples - provided that they are supplied in barcode-labeled vessels - up to the photometric measurement and results transmission to the computer unit. Additional detailed information about the Hitachi 917 Analyzer is contained in volume II of the premarket notification (K953239) cleared on September 25, 1995. #### V. Summary of the technological characteristics of the new device in comparison to those of the predicate. Tables 3 outlines the technological characteristics (methodologies) of the Abuscreen ONLINE Amphetamines test kit in comparison to that of the legally marketed predicate product. {3}------------------------------------------------ #### Brief discussion of the clinical and nonclinical tests relied on for a determination of VI. substantial equivalence: Tables 3 demonstrates the results of clinical and nonclinical studies performed using the Abuscreen ONLINE Amphetamines test kit on the Hitachi 917 Analyzer. The significant performance characteristics relied upon for a determination of substantial equivalence are summarized in this chart. This information concludes that the performance of this device is essentially equivalent to the legally marketed predicate device. {4}------------------------------------------------ ## Abuscreen ONLINE Amphetamines for Hitachi 917 Table 3 | | Proposed: | | Previously Cleared: (K933052) | | |----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----| | | Abuscreen ONLINE | | Abuscreen ONLINE | | | | Amphetamines for Hitachi 917 | | Amphetamines (1000 Test Kit) | | | Methodology | Kinetic interaction of<br>microparticles in a solution as<br>measured by changes in light<br>transmission | | Kinetic interaction of<br>microparticles in a solution as<br>measured by changes in light<br>transmission | | | Sample type | urine | | urine | | | Intended Use | qualitative and semiquantitative<br>detection of amphetamine and<br>methamphetamine and their<br>metabolites | | qualitative and semiquantitative<br>detection of amphetamine and<br>methamphetamine and their<br>metabolites | | | Calibrator | Abuscreen ONLINE Calibration<br>Pack or Abuscreen ONLINE<br>Calibrator Level 3 | | Abuscreen ONLINE Calibration<br>Pack or Abuscreen ONLINE<br>Calibrator Level 3 | | | Cutoff(s) | 1000 ng/mL | | 500 and 1000 ng/mL | | | Reagent (active<br>ingredients) | 1. Ab reagent: amphetamine<br>and methamphetamine<br>monoclonal (mouse) antibody in<br>buffer<br>2. Microparticle reagent:<br>Conjugated amphetamine<br>derivative microparticles in<br>buffer<br>3. Diluent: Buffer | | 1. Ab reagent: amphetamine<br>and methamphetamine<br>monoclonal (mouse) antibody in<br>buffer<br>2. Microparticle reagent:<br>Conjugated amphetamine<br>derivative microparticles in<br>buffer<br>3. Diluent: Buffer | | | Performance Characteristics: | | | | | | Precision Qualitative (1000 ng/mL Cutoff): | | | | | | | >95% negative at 750 ng/mL | | >95% negative at 800ng/mL | | | | >95% positive at 1250 ng/mL | | >95% positive at 1500 ng/mL | | | Within Run | Mean (OD) | CV% | | | | 500 ng/mL | 5117 | 0.5 | | | | 750 ng/mL | 3910 | 0.5 | | | | 1000 ng/mL | 3033 | 0.5 | | | | 1250 ng/mL | 2569 | 0.8 | | | | 1500 ng/mL | 2254 | 0.6 | | | | Day-to-Day | Mean (OD) | CV% | | | | 500 ng/mL | 5096 | 1.8 | | | | 750 ng/mL | 3905 | 1.6 | | | | 1000 ng/mL | 3061 | 1.4 | | | | 1250 ng/mL | 2548 | 1.7 | | | | 1500 ng/mL | 2232 | 1.8 | | | | Proposed: | | Previously Cleared: (K933052) | | | | Abuscreen ONLINE | | Abuscreen ONLINE | | | | | Amphetamines for Hitachi 917 | Amphetamines (1000 Test Kit) | | | | Precision Quantitative (1000 ng/mL Cutoff ): | | | | | | Within Run | Mean (ng/mL) | CV% | Mean (ng/mL) | CV% | | 500 ng/mL | 508 | 0.7 | 620 | 6 | | 750 ng/mL | 747 | 0.5 | 834 | 5 | | 1000 ng/mL | 1013 | 1.4 | 973 | 4 | | 1250 ng/mL | 1255 | 1.0 | 1177 | 3 | | 1500 ng/mL | 1485 | 1.0 | | | | Day-to-Day | Mean (ng/mL) | CV% | Mean (ng/mL) | CV% | | 500 ng/mL | 492 | 3.0 | 616 | 7 | | 750 ng/mL | 731 | 2.0 | 846 | 5 | | 1000 ng/mL | 1005 | 1.4 | 974 | 5 | | 1250 ng/mL | 1261 | 1.5 | 1181 | 4 | | 1500 ng/mL | 1475 | 1.4 | | | | Accuracy | | | | | | 1000 ng/mL Cutoff | N= 50 Confirmed Pos.<br>50 Pos. 0 Neg. | | N = 156 Confirmed Pos.<br>155 Pos. 1 Neg. | | | Limit of Detection | 11 ng/mL | | 30 ng/mL | | {5}------------------------------------------------ ## Abuscreen ONLINE Amphetamines for Hitachi 917 Table 3 (Continued) {6}------------------------------------------------ Image /page/6/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. DEC 1 1 1998 Ms. Rita Smith Senior Requlatory Affairs Associate Roche Diagnostic Systems, Inc. A Subsidiary of Hoffmann-La Roche, Inc. Branchburg Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Re : K983699 > Abuscreen ONLINE® Amphetamines Assay Trade Name: Requlatory Class: II Product Code: DKZ Dated: October 20, 1998 Received: October 21, 1998 Dear Ms. Smith: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, Druq, and Cosmetic Act (Act). 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 reqistration, 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obliqation you miqht have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {7}------------------------------------------------ #### 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"(21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Gutman 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 {8}------------------------------------------------ #### Page ー of 1 510(k) Number (if known) Device Name: Abuscreen ONLINE® Amphetamines Indications for Use: Abuscreen ONLINE for Amphetamines is an in vitro diagnostic test for the qualitative and semiquantitative detection of amphetamine and methamphetamine and their metabolites in human urine on automated clinical chemistry analyzers at a cutoff of 1000 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of amphetamine use or abuse. ### (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) (Division Sign-Off) Division of Clinical Laboratory Devices Laboratory Devices 99