RAPET RF

{0} K974370 510(k) Summary RaPET® RF FEB 17 1998 ## Submitter's Name Kirk Johnson Stanbio Laboratory, Inc. 2930 East Houston Street San Antonio, TX 78202 Tel. (210) 222-2108 Fax (210) 227-6367 Prepared By Kirk Johnson November 14, 1997 ## Product Name Trade Name: RaPET® RF Common Name: Rheumatoid Factor Test Classification Number: 82DHR ## Description of Device The device test kit is comprised of RF Latex Reagent, RF Positive Control, Negative Control and Glycine/Saline Buffer for performing semi-quantitative testing. ## Intended Use of Device RaPET® RF is intended for the qualitative and semi-quantitative detection of rheumatoid factor in human serum. The latex slide test is intended to be used as an aid in the diagnosis of rheumatoid arthritis. ## Comparison of Devices Both RF latex methods employ latex beads coated with human gamma globulin which agglutinate in the presence of rheumatoid arthritis serum. ## Performance Data Substantial equivalency was demonstrated by method comparison. Correlation was performed between the two test kits with a correlation coefficient of 0.998 and a regression equation of $Y=1.003X - 2.82$. In addition, precision, sensitivity, specificity, and interference studies were performed on RaPET® RF. Results of these tests were found to be acceptable. - 18 - MILITARY INFORMATION SERVICE 0000000000000000000000000000000000000000000000000000000000000000000000000000 {1} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Kirk Johnson Quality Assurance Manager Stanbio Laboratory, Inc. 2930 East Houston Street San Antonio, TX 78202 FEB 17 1998 Re: K974370 Trade Name: RaPET RF Regulatory Class: II Product Code: DHR 82 Dated: November 18, 1997 Received: November 20, 1997 Dear Mr. Johnson: 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 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. {2} 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 I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3} Page 1 of 19 510(k) Number (if known): K974370 Device Name: RaPET RF Indications For Use: RaPET RF (Class II) is intended for the qualitative and semi-quantitative detection of rheumatoid factor in human serum. The latex slide test is intended to be used as an aid in the diagnosis of rheumatoid arthritis.  (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)