MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the border of the circle. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 JUL 3 0 2001 The Binding Site Limited c/o Mr. Jay H. Geller West Tower, Suite 4000 2425 West Olympic Boulevard Santa Monica, CA 90404 510(K) Number: K011663 Re: Trade/Device Name: Minineph® a-1 Antitrypsin Antiserum Regulation Number: 866.5130 Regulatory Class: II Product Code: DEM Dated: May 24, 2001 Received: May 29, 2001 Dear Mr. Geller: We have reviewed your Section 510(k) notification of intent to market the device referenced we nave reviewed your Section 510(x) nother startially equivalent (for the indications for use above and we nave determined the actrectived predicate devices marketed in interstate commission stated in the encrosure) to legally me. Rote of the Medical Device Amendments, or to devices that prior to May 20, 1970, the chacances with the provisions of the Federal Food, Drug, and flave been reclassified in accordance the device, subject to the general controls Cosment Act (Act. Tou may) alercers) sprovisions of the Act include requirements for annual provisions of the Act. "The general oversions practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III II your device is classified (see aco re) into such additional controls. Existing major regulations (Fremarket Approval), it they be basyee to sate of Federal Regulations, Title 21, Parts 800 to 895. arrecting your de rive sant determination assumes compliance with the Current Good A Substantiany Squrvalent determinates set forth in the Quality System Regulation (QS) for Manufacturing Fractive requations (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to inspections, the rood and Drug Nammount in to to and in addition, FDA may publish Comply with the Offir Tegaration mayor careering your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might response to your promanters of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {1}------------------------------------------------ ## Page 2 This letter will allow you to begin marketing your device as described in your 510(k) prematket I his letter will anow you to begin marketing your device to a legally marketed notification. The IDA inding of substantar required. 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 CFF Part 801 and If you desire specific advice for your do rise are are an actually office of Compliance at additionally 809.10 for mi vitio diagnostions on the promotion and advertising of your device, (301) 594-4588. Additionally, for questions on the p-4639. Also, please note the regulation Please contact the Office of Compliance at (301) 594-4639. Also, please of Col please contact the Office of Complanse as (355) of the motification" (21CFR 807.97). Other general entitled, "Wisoranuming by relevelo to premier to the Act may be obtained from the Division of Small information on your responsibilities ander and re(800) 638-2041 or (301) 443-6597 or at its Manufacturers 1 13515tailos av 1 tda.gov/cdrl/dsma/dsmamain.html". Sincerely yours, Steven Butman 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}------------------------------------------------ ## K01163 INDICATIONS FOR USE STATEMENT Minineph® a-1 Antitrypsin Antiserum Device Name: Indications for Use: This assay is designed for the in_xirro Indications for Use. Intitrypsin in serim using the Minineph®, as an aid in the diagnosis of several conditions, including juvenile and adult cirrhosis of the liver. In addition, a-1 juvenile and adult cirritosis of the friver. An entired with pulmonary emphysema . Jonel Webb Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number_Call G (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 Formal 1-2-96