BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003

{0}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. Public Health Service JUN 2 2 1999 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Biocheck, Inc. c/o Ms. Robin J. Hellen, M.S. Ilellen Professional Services 9418 Lasaine Avenue Northridge, California 91325 Re: K990993 > Trade Name: Biocheck Sensitive Thyroid Stimulating Hormone (S-TSH) Enzyme Immunoassay Test Kit Regulatory Class: II Product Code: JLW Dated: March 22, 1999 Received: March 24, 1999 Dear Ms. Hellen: 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 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). 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 (I'remarket 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. {1}------------------------------------------------ ## Page 2 Page 2 Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may Under the Clinical Laboratory Improvement Amendments of 1988 (CEIA-10), Microsoft require a CLIA complexity categorization. To determine if it does, you should contact the require a CLIA complexity categorization. 10 december 2011 at 1770) 488-7655. Centers for Disease Control and Prevention (CDC) at (770) 488-7655. Chicks to Liseans Course of Substantial equivalence as described in your 10(k) prematice This letter will allow of substantial equivalence of your device to a legally marked This letter will allow you to begin marketing your device to a legally harketed a notification. The FDA finding of substantial equivalence of your device to I his letter will and with the of substantial equivalence of your device to as anyally predicate device results in a classification for your device and thus, permits your dev proceed to the market. pfoceed to the mainter. If you desire specific advice for your device on our labeling regulation (21 CFR, Part 801 and If you desire specific advice for your devices), please contact the Office of Cyour device at additionally 809.10 for in vitro diagnostic devices), please contact the Office (301) 594-458. Additionally, for questions on the promotion and advise. (301) 594-458. Additionally, for questions on the promotion and advice. (301) 594-4588. Additionall (301) 594-4588. Additionally, for questions on the promotion and also, please of the regulation (301) 594-4588. Additionally, for questions on the regulation (501) 394-5500: 1122. States to permarket notification"(21 CFR 807). Chhe Collected Collected on States of Stices of Stical of Stical of Stical of Sinali entitled, "Misbrandi please connact the best of premarket notification (21 CFR 001. For and Comments of Sunal) entitled, "Misbranding by refects" to premarket from the Division of Sunall information on your responsibilities under the Act may be oblamber (801) 443-6597, or at its Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-659 Manufacturers Assistance at its ton-free hances (117) internet address "http://www.fda.gov/cdrl/dsmaldsmamain.html". Internet address "http://www.fda.gov/cdrl/dsmaldsmamain.h Sincerely yours, Steven Autman 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}------------------------------------------------ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ PART I - 510(k) Information ## Statement for Indications for Use lll. | 510(k) Number (if known): | K990993 | |---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name: | BioCheck, Inc. Sensitive TSH EIA | | Indications for Use: | The BioCheck S-TSH EIA is intended for the quantitative determination of thyrotropin, of thyroid stimulating hormone (TSH) in human serum. The assay is useful in the diagnosis of thyroid or pituitary disorders. | | (Division Sign-Off) | | |-----------------------------------------|---------| | Division of Clinical Laboratory Devices | | | 510(k) Number | K990993 | Concurrence of the CDRH, Office of Device Evaluation (ODE) | Prescription Use: | OR | Over the Counter Use: | |-------------------|----|-----------------------| |-------------------|----|-----------------------| \$\partial\$