IMMUNOCARD STAT! ROTAVIRUS

{0}------------------------------------------------ K471585 # 510(k) Summary ImmunoCard STAT! Rotavirus ﻤﺴﯿﺴﯿﺪ Meridian Diagnostics, Inc. Cincinnati, Ohio 45244 ### APPENDIX A - 510(k) Summary ## A. Identification Information AUG 20 1997 - 1) Submitter's Information: - a) Submitter's Name and Address: Meridian Diagnostics, Inc. 3471 River Hills Drive Cincinnati. OH 45244 - b) Phone Number: 1-800-543-1980 - c) Contact Person: Allen D. Nickol, PhD Director of Scientific and Regulatory Affairs - d) Date Summary Prepared: April 30, 1997 - 2) Name of Device: ImmunoCard STAT Rotavirus. Classification Name: Enzyme Linked Immunoabsorbent Assay, Rotavirus. - Predicate Equivalent Device: Premier Rotaclone and Abbott Test Pack EIA's. 3) - Description of Device: The ImmunoCard STAT! Rotavirus assay system is a 4) membrane based immunogold assay for rotavirus. Each kit contains the following components: - a) ImmunoCard STAT! Rotavirus devices(30) - b) Positive Control (1.8ml) - c) Sample Diluent (10.5ml) - d) Transfer Pipets (30) In brief, 1/15 diluted stool enters the sample application pad and migrates through the conjugate pad. Monoclonal antibody (conjugated to colloidal gold particles) contained in the pad is dissolved in the specimen and travels onto the nitrocellulose membrane. The nitrocellulose membrane contains two "capture" zones. The first holds polyclonal antibody to rotavirus, and the second has polyclonal anti-mouse IgG. The first zone serves as the test line, indicating the presence of rotavirus. The second zone {1}------------------------------------------------ acts as a procedural control and verifies that the sample has migrated sufficiently into the device to permit a valid test result to be read in the first (test) zone. The final absorbent pad acts as a reservoir and draws the sample through the test strip. - Intended Use: The ImmunoCard STAT! Rotavirus Immunoassay is a rapid in vitro 5) qualitative procedure for the detection of rotavirus antigen in human stool. The test can be used to aid in the diagnosis of rotavirus associated gastroenteritis. #### Comparison with Predicate Devices: 6) The following comparison of the use, technology, function and performance supports the Statement of Equivalence between the ImmunoCard STAT! Rotavirus test and enzyme immunoassay testing (Premier Rotaclone® and Abbott Test Pack®). | Method | ImmunoCard STAT!<br>Rotavirus | Premier<br>Rotaclone | Abbott<br>Test Pack | |---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Detection of rotavirus in patient stool | | | | Results | Qualitative | | | | Technology | Immunoassay | | | | Function<br>Capture<br>Detection<br>Color Change<br>Chromogen<br>Procedure | Polyclonal Rabbit Ab<br>Monoclonal Ab-Gold<br>White to Red / Purple<br>Colloidal Gold<br>1. 1/15 dilution<br>2. 150µl addition<br>3. Ten min RT incubation<br>4. Read visible results | Monoclonal Ab<br>Monoclonal Ab-HRP<br>Clear to Blue<br>TMB<br>1. 1/41 dilution<br>2. 100µl addition<br>3. 2 drops conjugate<br>4. mix<br>5. 60 min RT incubation<br>6. Decant & Wash 5X<br>7. 2 drops substrate<br>8. 2 drops chromogen<br>9. 10 min RT incubation<br>10. Read visible or 450nm Abs.<br>results | Polyclonal Guinea Pig Ab<br>Monoclonal Ab-Alk. Phos.<br>White to Purple<br>Unknown<br>1. 1/11 dilution and<br>filtration<br>2. 3 drops conjugate<br>3. 5 min RT incubation<br>4. Pour through device and<br>remove focuser<br>5. Wash (fill)<br>6. 3 drops substrate<br>7. 2 min RT incubation<br>8. Wash (fill)<br>9. Read visible results | | Interpretation | Pos/Neg/Invalid | Pos/Neg | Pos/Neg/Invalid | | Performance vs Electron Microscopy<br>Sensitivity<br>Specificity<br>Correlation | 93.1%<br>95.8%<br>94.4% | 93.8%<br>94.1%<br>94.0% | 93.8%<br>90.8%<br>92.4% | | Performance vs Premier Rotaclone<br>Sensitivity<br>Specificity<br>Correlation | 97.7%<br>100.0%<br>98.8% | NA<br>NA<br>NA | 98.4%<br>95.0%<br>96.8% | {2}------------------------------------------------ ### 510(k) Summary ImmunoCard STAT! Rotavirus ﻟﻤﺴﺴﺴ #### Additional Information/Non-clinical Test Results: B. - 1) Sensitivity Limits: The sensitivity of the ImmunoCard STAT! Rotavirus is approximately 1.8-3.7 x 106 viral particles. - 2) Reproducibility: Reproducibility of the ImmunoCard STAT! Rotavirus test was 100% on controls, negative and moderate positive stools, and 96% on low positive stools. - 3) Fresh versus Frozen Stools: The data indicated rotavirus is stable in stool for at least three days when stored at 4°C or frozen at ≤-20°C. - 4) Cross-Reactivity: Testing of the ImmunoCard STAT! Rotavirus with a panel of bacteria and viruses gave no false positive or false negative results. - 5) Interfering Substances: Testing of the ImmunoCard STAT! Rotavirus with blood showed that high levels (≥33%) could affect flow, resulting in an occasional invalid test result. No effect from barium sulfate was observed. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three swooping lines forming its body and wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a sans-serif font. The text is arranged around the circle's perimeter, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" at the top and "USA" at the bottom. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Allen D. Nickol, Ph.D. Director of Scientific and Regulatory Affairs * Meridian Diagnostics, Inc. 3471 River Hills Drive Cincinnati, Ohio 45244 AUG 20 1997 Re: K971585 Trade Name: ImmunoCard® STAT! Rotavirus Regulatory Class: I Product Code: LIQ Dated: June 30, 1997 Received: July 1, 1997 Dear Dr. Nickol: 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 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federai 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. {4}------------------------------------------------ Page 2 Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655. 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html" Sincerely yours, Steven Sutman 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}------------------------------------------------ # Meridian Diagnostics, Inc. Cincinnati, OH 45244 ) #### C. Indications for Use Statement: 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: ImmunoCard® STAT! Rotavirus Indications For Use: For use to detect the presence of rotavirus in stool specimens from patients with loose stools, diarrhea, gastroenteritis, or suspected to be infected with rotavirus. ### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Re R --- - Sign Off (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number. K971585 **Prescription Use** (Per 21 CFR 801.109) √ 1 OR Over-The-Counter Use (Optional Format 1-2-96)