DAPTOMYCIN

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 DEC 1 3 2004 Ms. Anne Bolmström President & CEO AB Biodisk Dalvägen 10 S-169 56 Solna Sweden k042392 Re: Trade/Device Name: Etest® Daptomycin 0.016-256 µg/mL Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY Dated: December 3, 2004 Received: December 3, 2004 Dear Ms. Bolmström: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). {1}------------------------------------------------ ## Page 2 This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ogen mailioning of substantial equivalence of your device to a legally prematics notification: The PDF Americation for your device and thus, permits your device to proceed to the market. If you desire specific information about the application of labeling requirements to your device, If you desire specific monitiation and advertising of your device, please contact the Office of or questions on the promotion and Safety at (301) 594-3084. Also, please note the In Pill o Diagnostic Dorloo Drarance to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours, Saqartys Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known): k042392 Device Name: Etest® Daptomycin 0.016-256 µg/mL Indications For Use: For in vitro diagnostic use: Etest is a quantitative technique for the determination of antimicrobial susceptublity of both nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriansmassess, fastidious Grain negative and Chain posts ro associal, such as anaerones, Prammonons, Staphyloocws, Gonorous and Haemophius species. The system comprises a predefined and high in and the Streportus, Goldential and Plannylims openion inhibitory concentration (MIC) in ug/ml of gradent which is used to determine the minimals and media by overnight incubation. (Original FDA clearance for Etest - file K913459/A) This Etest 510(k) submission is for an additional antibiotic i.c. Etest for MIC deemination of This Etest 310(K) Submission is 10.016 - 256 µg/ml with E. faecalis and E. Jaeium (vancomycin-Daptomyen in the MIC faires of over including methicillin resistant strains), coagulase negative Staphylococcus spp. and ß-haemolytic Streptococcus spp. Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (Please do not write below This Line-continue on another Page IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Luddie L. Poole Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Saicty 510(k) Page 1 of _1 C:\Documents and Settings\MBB\Desktop\OlVD\Review AST 510K\AB Biodisk\Daptomycin k042392le-mail 1104\IFU 0411.DOC