PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is an abstract image of an eagle. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 SEP 4 1998 Mr. Brys C. Myers Manager Requlatory Affairs INOVA Diagnostics, Inc. 10180 Scripps Ranch Blvd. San Diego, CA 92131 Re: K982023 Trade Name: Peliclass Human IGG Subclass Nephelometric Array Kit Regulatory Class: II Product Code: DAS Dated: June 2, 1998 Received: June 09, 1998 Dear Mr. Myers: 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 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 Requlations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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. {1}------------------------------------------------ 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 leqally 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 för 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/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 {2}------------------------------------------------ Page ____of___ | 0(k) Number (if known): | K982023 | |-------------------------|---------| |-------------------------|---------| Peliclass™ Human IgG Subclass Nephelometric Array® Kit Device Name: Device Number:***_****_* Indications For Use: 4046 6351 0734 The contents of the Peliclass ™ subclass nephelometric Array® kit will allow quantitative determination of all four IgG subclasses in at least 25 samples with the Beckman Array ® Protein System. The determination of IgG subclasses is to be used in conjunction with other clinical findings to aid in the assessment of the humoral immune status. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Peter E. Mapes (Division Sign-Off) Division of Clinical Laboratory Devices K982023 510(k) Number . **Prescription Use** (Per 21 CFR 801.109) ✓ OR Over-The-Counter Use (Optional Format 1-2-96)