BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY

{0}------------------------------------------------ Attachment 3 #### 7 1998 DEC ## Summary of Safety and Effectiveness # Bayer Immuno 1™ System Upgraded for Laboratory Automation Capability This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. Below is a comparison of performance, using eight representative assays, between the Bayer Immuno 1 System upgraded for Laboratory Automation capability and the Bayer Immuno 1™ System, already granted clearance of substantial equivalence for these representative and other assays. #### Intended Use The Bayer Immuno 1 System upgraded for laboratory automation capability will facilitate communication and robotic transfer of samples to and from a Laboratory Automation system. The Laboratory Automation system will coordinate the scheduling, sample identification, and physical transfer of samples. #### Device Bayer Immuno 1" System Upgraded for Laboratory Automation Capability Gabriel J. Murace, Jr. Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097 9/21/98 Date {1}------------------------------------------------ | Part Numbers | | | |--------------|-----------|---------------------------------------------------| | | CEA: | Reagents: T01-3184-51<br>Calibrators: T03-3188-01 | | | FSH: | Reagents: T01-3086-51<br>Calibrators: T03-3148-01 | | | Free T4: | Reagents: T01-3360-51<br>Calibrators: T03-3401-01 | | | PSA: | Reagents: T01-3450-51<br>Calibrators: T03-3541-01 | | | T3: | Reagents: T01-2949-01<br>Calibrators: T03-2872-01 | | | T4: | Reagents: T01-3260-51<br>Calibrators: T03-3174-01 | | | TSH: | Reagents: T01-2942-51<br>Calibrators: T03-3568-01 | | | T-Uptake: | Reagents: T01-3036-51<br>Calibrators: T03-3076-01 | ### Predicate Device Bayer Immuno 1™ System ## Part Numbers The part numbers are identical to those used for the Bayer Immuno 1 " System upgraded for laboratory automation capability. . {2}------------------------------------------------ | BAYER IMMUNO 1™ UPGRADED SYSTEM | | | BAYER IMMUNO 1™ METHOD SHEET | | |---------------------------------|-----------------|-----------------|------------------------------|-----------------| | METHOD | MEAN<br>(UNITS) | TOTAL<br>CV (%) | MEAN<br>(UNITS) | TOTAL<br>CV (%) | | CEA | 1.54 ng/mL | 3.3 | 2.9 ng/mL | 2.3 | | | 13.29 ng/mL | 1.2 | 8.9 ng/mL | 2.2 | | | 63.43 ng/mL | 1.4 | 18.2 ng/mL | 1.8 | | FSH | 9.4 mIU/mL | 1.6 | 5.5 mIU/mL | 3.2 | | | 15.26 mIU/mL | 1 | 12.3 mIU/mL | 2.8 | | | 47.51 mIU/mL | 0.7 | 30.3 mIU/mL | 2.8 | | FREE T4 | 0.83 ng/dL | 4.1 | 0.36 ng/dL | 15.4 | | | 1.43 ng/dL | 4.3 | 1.25 ng/dL | 6.0 | | | 3.06 ng/dL | 4.7 | 4.35 ng/dL | 3.1 | | PSA | 2.89 ng/mL | 3.1 | 0.05 ng/mL | 0.007 ng/mL | | | 6.9 ng/mL | 2.4 | 0.92 ng/mL | 2.9 | | | 26.41 ng/mL | 2.4 | 2.68 ng/mL | 3.1 | | | | | 9.87 ng/mL | 2.2 | | | | | 23.02 ng/mL | 3.4 | | | | | 49.13 ng/mL | 2.0 | | | | | 96.38 ng/mL | 2.5 | | T3 | 0.66 ng/mL | 5.1 | 0.46 ng/mL | 13.3 | | | 1.78 ng/mL | 2.4 | 1.34 ng/mL | 6.0 | | | 2.9 ng/mL | 2 | 3.43 ng/mL | 3.9 | | T4 | 3.31 µg/dL | 1.6 | 4.7 µg/dL | 3.6 | | | 7.57 µg/dL | 2.2 | 8.2 µg/dL | 2.6 | | | 14.12 µg/dL | 1.2 | 15.7 µg/dL | 2.5 | | TSH | 0.55 µIU/mL | 6.4 | 0.1 µIU/mL | 13.0 | | | 5.08 µIU/mL | 1 | 1.3 µIU/mL | 6.3 | | | 32.73 µIU/mL | 1.2 | 9.0 µIU/mL | 2.0 | | | | | 22.5 µIU/mL | 1.8 | | T-UPTAKE | 0.97 | 3.3 | 0.71 | 2.8 | | | 1.03 | 3.1 | 1.03 | 2.6 | | | 1.24 | 2.2 | 1.41 | 2.4 | . - 1) Precision for Bayer Immuno 1™ System Upgraded for Laboratory Automation Capability: * Standard deviation : . : ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺴﺎﻋﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟ {3}------------------------------------------------ ## 2) Correlation: | COMPARISON<br>METHOD | NUMBER<br>OF<br>SAMPLES | REGRESSION<br>EQUATION<br>y = | CORRELATION<br>COEFFICIENT<br>r | STANDARD<br>ERROR<br>Sy.x | RANGE OF<br>ANALYTE<br>CONCENTRATION | |----------------------|-------------------------|-------------------------------|---------------------------------|---------------------------|--------------------------------------| | CEA | 360 | 1.01x - 0.01 | 0.998 | 0.116 | 0.4 - 16.4 ng/mL | | FSH | 360 | 0.99x + 0.02 | 0.999 | 0.841 | 0 - 145 mIU/mL | | Free T4 | 355 | 0.99x + 0.04 | 0.988 | 0.042 | 0.26 - 1.98 ng/dL | | PSA | 200 | 1.00x + 0.01 | 1.000 | 0.066 | 0 - 20.3 ng/mL | | T3 | 360 | 0.99x + 0.02 | 0.987 | 0.046 | 0.48 - 2.16 ng/mL | | T4 | 356 | 0.98x + 0.07 | 0.997 | 0.141 | 3.7 - 16.4 µg/dL | | TSH | 360 | 0.99x + 0.02 | 1.000 | 0.108 | 0.23 - 77 µIU/mL | | T-Uptake | 358 | 0.98x + 0.03 | 0.991 | 0.019 | 0.61 - 1.41 | : . : : . y = Bayer Immuno 1™ System upgraded for laboratory automation capability x = Bayer Immuno 1™ System : : : . {4}------------------------------------------------ Image /page/4/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a single snake winding around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 DEC 7 1998 Gabriel J. Muraca, Jr. Manager Requlatory Affairs BAYER CORPORATION 511 Benedict Avenue Tarrytown, NY 10591-5097 Re: K983345 Trade Name: Bayer Immuno 1™ System Upgraded for Laboratory Automation Capability Requlatory Class: II Product Code: JJE September 22, 1998 Dated: Received: September 23, 1998 Dear Mr. Muraca: 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, Drug, 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 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 (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 regulation (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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {5}------------------------------------------------ #### 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 general 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 Autman 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 {6}------------------------------------------------ Page 1 of 1 1. 1. 1. 1. ### 510(k) Number (if known): K983345 # Device Name: Bayer Immuno 1™ System Upgrade for LAS Indications For Use: The Bayer Immuno 1™ System has been upgraded for Laboratory Automation capability. Software and Hardware will facilitate communication and robotic transfer of samples to and from a Laboratory Automation system. The Laboratory Automation System (LAS) will coordinate the scheduling, sample identification, and physical transfer of samples, as demonstrated for the following representative methods: CEA, FSH, Free T4, PSA, T3, T4, TSH, and T-Uptake. _ . . .. . . (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 Laboratos ! 510(k) Number ________________________________________________________________________________________________________________________________________________________________ 983345 1-2