LEADCARE BLOOD LEAD TESTING SYSTEM

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized human figure with three overlapping profiles, representing health and well-being. The emblem is positioned to the right of the department's name, which is arranged in a circular fashion around the emblem. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA". Food and Drug Administration 2098 Gaither Road Rockville MD 20850 g (297 SEP James Mayol Quality Assurance Manager ESA, Inc. 22 Alpha Road Chelmsford, Massachusetts 01824-4171 K971640 Re : Leadcare Blood Lead Testing System Requlatory Class: ı il Product Code: DOF July 30, 1997 Dated: Received: August 1, 1997 Dear Mr. Mayol: 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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. ਬੇ 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 . {1}------------------------------------------------ Page 2 Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity (chin 60), chib dollor as mine 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 described in your sio\n / pivalence of your device to a legally marketed predicate device results in a classification for your markets 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Steven Litman 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}------------------------------------------------ 510(k) Number (if Known):_ Device Name: LEADCare Blood Lead Testing System Indications For Use: The LEADCARE™ Blood Lead Testing System is an instrumented assay to be used in the The LEADCARE™ Blood I-cad in human whole blood. The LEADCARE System is suitable for use quantitation of lead in namatory environment (POL). SINEINO (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |--------------------------------------------------------|---------| | (Division Sign-Off) | | | Division of Clinical Laboratory Devices | | | 510(k) Number | 5971640 | | Prescription Use | OR | Over-The-Counter Use | |----------------------|----|--------------------------| | (Per 21 CFR 801.109) | | (Optional Format 1-2-96) |