VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY

{0}------------------------------------------------ K101234 ## 510(k) Summary AUG 25 2011 Submitter: Ventana Medical Systems, Inc. Judy Howe Contact: (original): 30-Apr-2010 Date Prepared Date Revised: 26-Jul-2011 ## 510(k) SUMMARY 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. The assigned 510(k) number is: K101234 | Device Name | VENTANA anti-Helicobacter pylori (SP48) Rabbit Monoclonal Primary Antibody | | | |-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Common name: | IHC laboratory test for detection of Helicobacter pylori | | | | Classification: | 21CFR866.3110, Immunology and Microbiology Devices | | | | Product Code: | LYR | | | | Device Description | IHC <i>in vitro</i> diagnostic antibody directed against <i>H. pylori</i> organisms and visualized<br>though the application of either of two standard chromogenic secondary detection kits<br>to locate and bind primary antibodies bound to tissue samples. Use of either detection<br>system results in a dark brown colored precipitate at the site of specific antibody<br>binding. | | | | Intended Use | VENTANA anti-Helicobacter pylori (SP48) Rabbit Monoclonal Primary Antibody is<br>designed to qualitatively detect the presence of Helicobacter pylori in formalin-fixed,<br>paraffin-embedded gastric biopsy tissue via light microscopy. Immunohistochemical<br>staining with this antibody product may aid in the diagnosis of Helicobacter pylori<br>infection. This product should be interpreted by a qualified pathologist in conjunction<br>with histological examination, relevant clinical information and proper controls.<br>This antibody is intended for <i>in vitro</i> diagnostic (IVD) use. | | | | Summary of the new devices | VENTANA anti-Helicobacter pylori (SP48) is substantially equivalent to a commercially<br>available predicate device.<br>Ventana has evaluated the performance of VENTANA anti-Helicobacter pylori (SP48)<br>by comparing it with Ventana Giemsa Staining Kit and <i>H. pylori</i> diagnosis obtained<br>from enrollment pathology reports for the detection of <i>H. pylori</i> infection in gastric<br>biopsy tissue for patients. The Ventana Giemsa Staining Kit is a qualitative histologic<br>stain to differentiate leukocytes in bone marrow and other hematopoietic tissue (lymph<br>nodes) in formalin fixed, paraffin embedded tissue and can also be used to<br>demonstrate some microorganisms, including <i>H. pylori</i> .<br>Geimsa stains all enteric bacteria blue while VENTANA anti-Helicobacter pylori (SP48)<br>detects the whole <i>H. pylori</i> organism <i>in situ</i> . The characteristic helical shape and<br>localization of the organisms within the crypts of the mucosa assist the clinician in<br>making an accurate diagnosis of infection. | | | | Non-clinical performance data | Non-clinical performance testing has been conducted to demonstrate performance<br>characteristics of VENTANA anti-Helicobacter pylori (SP48). Results of tissue-<br>specificity and precision testing are noted in the product package insert. | | | | Clinical performance data | A Method Comparison study was conducted to demonstrate the percent positive and<br>negative agreement rates for the comparison of VENTANA anti- <i>H. pylori</i> (SP48)<br>Rabbit Monoclonal Primary Antibody with Ventana Giemsa Staining Kit for determining<br>the presence of <i>H. pylori</i> at three independent clinical sites. A total of 294 cases were<br>considered evaluable by both assay methods and were therefore included in the<br>analyses of agreement rates between VENTANA anti- <i>H. pylori</i> (SP48) and Ventana<br>Giemsa Staining Kit. Pooled data from all sites demonstrated positive agreement in | | | | COMPARISON OF VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY<br>TO PREDICATE DEVICE, PYLO-PLUS, K052708 | | | | | PARAMETER | PREDICATE DEVICE | PROPOSED DEVICE | | | PROPRIETARY<br>NAME | PYLO-PLUS, K052708 | VENTANA ANTI-HELICOBACTER PYLORI (SP48)<br>RABBIT MONOCLONAL PRIMARY ANTIBODY | | | FDA<br>CLASSIFICATION | CLASS I, NON-EXEMPT | CLASS I, NON-EXEMPT | | | INTENDED USE | PYLO-PLUS IS INTENDED FOR<br>QUALITATIVE DETECTION OF THE<br>UREASE ENZYME IN GASTRIC MUCOSAL<br>BIOPSY SPECIMENS AND FOR THE<br>PRESUMPTIVE DETERMINATION OF<br>HELICOBACTER PYLORI IN<br>SYMPTOMATIC ADULT PATIENTS. | VENTANA MEDICAL SYSTEMS' VENTANA ANTI-<br>HELICOBACTER PYLORI (SP48) RABBIT<br>MONOCLONAL PRIMARY ANTIBODY IS DESIGNED<br>TO QUALITATIVELY DETECT THE PRESENCE OF<br>HELICOBACTER PYLORI IN FORMALIN FIXED,<br>PARAFFIN EMBEDDED GASTRIC BIOPSY TISSUE VIA<br>LIGHT MICROSCOPY. IMMUNOHISTOCHEMICAL<br>STAINING WITH THIS ANTIBODY PRODUCT MAY AID<br>IN THE DIAGNOSIS OF HELICOBACTER PYLORI<br>INFECTION. THIS PRODUCT SHOULD BE<br>INTERPRETED BY A QUALIFIED PATHOLOGIST IN<br>CONJUNCTION WITH HISTOLOGICAL EXAMINATION,<br>RELEVANT CLINICAL INFORMATION AND PROPER<br>CONTROLS.<br>THIS ANTIBODY IS INTENDED FOR <i>IN VITRO</i><br>DIAGNOSTIC (IVD) USE. | | | SAMPLE | GASTRIC MUCOSAL BIOPSY<br>SPECIMENS | FORMALIN-FIXED, PARAFFIN-EMBEDDED GASTRIC<br>BIOPSY TISSUE | | | ASSAY METHOD | SEROLOGICAL REAGENT | IHC WITH SECONDARY DETECTION | | | TARGET | UREASE ENZYME | WHOLE ORGANISM | | | ASSAY FORMAT | MANUAL | AUTOMATED | | | DETECTION<br>SYSTEM | DIRECT | INDIRECT | | | VISUALIZATION | INTERPRETATION BY COLORIMETRIC | INTERPRETATION BY LIGHT MICROSCOPY | | | PARAMETER | PREDICATE DEVICE | PROPOSED DEVICE | | | PROPRIETARY<br>NAME | Pylo-Plus, K052708 | VENTANA ANTI-HELICOBACTER PYLORI (SP48)<br>RABBIT MONOCLONAL PRIMARY ANTIBODY | | | | MAGENTA | | | | INTENDED USE<br>POPULATION | GASTRIC BIOPSY FROM PATIENTS<br>SUSPECTED OF HAVING H. PYLORI | GASTRIC BIOPSY FROM PATIENTS SUSPECTED OF<br>HAVING H. PYLORI | | | QUALITATIVE OR<br>QUANTITATIVE | QUALITATIVE | QUALITATIVE | | | CONCLUSION | VENTANA anti-Helicobacter PYLORI (SP48) IS SUBSTANTIALLY EQUIVALENT TO PYLO-<br>PLUS IN RELEVANT CHARACTERISTICS AND THE PERFORMANCE DIFFERENCES WILL NOT<br>ADVERSELY AFFECT SAFETY AND EFFICACY. | | | {1}------------------------------------------------ . . {2}------------------------------------------------ . . . . . . . and the comments of the comments of the comments of the comments of ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ and the comments of the comments of the country of the county of the county of {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 VENTENA Medical Systems, Inc. c/o Ms. Judy Howe Regulatory Affairs Specialist 1910 Innovation Park Drive Tucson, AZ 85755 AUG 25 2011 K 101つなん Re: | K101234 | | |--------------------|-----------------------------------------------------------| | Trade/Device Name: | VENTANA anti-Helicobacter pylori (SP48) Rabbit Monoclonal | | | Primary Antibody | | Regulation Number: | 21CFR §866.3110 | | Regulation Name: | Campylobacter fetus serological reagents | | Regulatory Class: | Class I | | Product Code: | OWF | | Dated: | August 10, 2011 | | Received: | August 15, 2011 | Dear Ms. Howe: 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 class II (Special Controls), 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. This letter will allow you to begin marketing your device as described in your Section {4}------------------------------------------------ Page 2 - Ms. Judy Howe 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 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (01) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to paremarket 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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 no (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Freddie M. Poole Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## Indications for Use 510(k) Number: K101234 Device Name: VENTANA anti-Helicobacter pylori (SP48) Rabbit Monoclonal Primary Antibody Indications for Use: VENTANA anti-Helicobacter pylori (SP48) Rabbit Monoclonal Primary Antibody (VENTANA anti-H. pylori (SP48)) is designed to qualitatively detect the presence of Helicobacter pylori in formalin-fixed, paraffin-embedded gastric biopsy tissue via light microscopy. Immunohistochemical staining with this antibody product may aid in the diagnosis of Helicobacter pylori infection. This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information and proper controls. This antibody is intended for in vitro diagnostic (IVD) use. Prescription Use __________AND/OR Over-the Counter Use (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Freddie Tu. Pool Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) k 101237 Page 1 of 1