Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. October 19, 2018 Immuno Concepts, N.A., Ltd. Eric Hoy Chief Scientific Officer 9825 Goethe Road, Suite 350 Sacramento, California 95827 Re: K180202 Trade/Device Name: Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: DBL, PIV Dated: September 19, 2018 Received: September 20, 2018 Dear Eric Hoy: 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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. ## Douglas A. Jeffery -S For, Lea Carrington Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ | DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: 06/30/2020<br>See PRA Statement below. | |-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------| |-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------| **Indications for Use** | 510(k) Number (if known) | K180202 | |--------------------------------|----------------------------------------------------------------------------------------------| | Device Name | HISTOFLUOR RODENT LKS FLUORESCENT ANTIBODY TEST SYSTEM<br>Image Navigator by Immuno Concepts | | Indications for Use (Describe) | | INTENDED USE: This is an indirect Fluorescent antibody test for the qualitative and semi-quantitative detection of IgG autoantibodies in human serum by manual fluorescent microscopy or with the Image Navigator® Fluorescence SemiAutomated Microscope. This test system is to be used as an aid in the detection of anti-mitochondrial (AMA), antiparietal cell (APCA), and anti-smooth muscle (ASMA) autoantibodies associated with Type 1 Autoimmune Hepatitis, Primary Biliary Cholangitis, and Pernicious Anemia/Autoimmune Gastritis in conjunction with other laboratory and clinical findings. A trained operator must confirm results generated with the Image Navigator® semi-automated device and software. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | <div> <span> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | CONTINUE ON A SEPARATE PAGE IF NEEDED. 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FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 and the comments of the state of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the contribution of the consi Comments of Children . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . :