N LP(A) STANDARD SY

{0}------------------------------------------------ # NOV 0 9 2001 ## 510(k) Summary For N Lp(a) Standard SY K 013126 Manufacturer's Name, Address, Telephone, and Contact Person, Date of 1. Preparation: Manufacturer: Dade Behring Marburg GmbH Emil-von-Behring Str. 76 Marburg/Germany Contact Information: Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714 Attn: Rebecca S. Ayash Tel: 302-631-6276 Preparation date: September 14, 2001 Class II (862.1150) #### Device Name/ Classification: 2. N Lp(a) Standard SY: Calibrator Classification Number: # Identification of the Legally Marketed Device: Beckman Coulter Lipoprotein(a) Calibrator (LPA CAL), K000121 #### Device Description: 4. 3. N L.p(a) Standard SY is a lyophilized standard prepared from human serum with stabilizers and preservative. It is intended to establish reference curves for the olublizative determination of human lipoprotein(a) [Lp(a)] by immunochemical with BN™ Systems. #### Device Intended Use: 5. Establishment of reference curves for the immunochemical determination of human lipoprotein(a) [Lp(a)] in serum or plasma with BN™ Systems. #### Medical device to which equivalence is claimed and comparison information: 6. There are a number of in vitro diagnostic products that are used for the establishment of reference curves. One such product is the Beckman Coulter Lipoprotein(a) Calibrator (LPA CAL), K000121. N Lp(a) Standard SY, like the LPA CAL is intended to be used for the calibration of Lp(a) protein by rate nephelometry. #### Device Performance Characteristics: 7. ### Stability: Stability was evaluated according to Dade Behring protocols and the standard was found to be stable for at least 24 months at +2° to +8° C, as originally packaged and for at least 5 days at +2° to +8° C, once reconstituted. Image /page/0/Picture/26 description: The image shows the number 00020 in a bold, sans-serif font. The numbers are black and the background is white. The numbers are slightly distorted, as if they were printed on a rough surface. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. The logo is in black and white. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 NOV 0 9 2001 Ms. Rebecca S. Ayash Director, Regulatory Affairs Dade Behring Inc. P.O. Box 6101 Newark, DE 19714 Re: k013126 Trade/Device Name: N Lp(a) standard SY Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIS Dated: September 14, 2001 Received: September 19, 2001 Dear Ms. Ayash: 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {2}------------------------------------------------ Page 2 - This letter will allow you to begin marketing your device as described in your 510(k) prematket notification. The FDA finding of substantial equivalence of your device to a legally marketed notification. The FDA inding of succementary of career and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (2) CFR Part 801 and 1 If you desire specific advice for your actives), please contact the Office of Compliance at additionally 807.10 for in viue diagliestions on the promotion and advertising of your device, (301) 594-4508. Addinonally, 10. quee at (301) 594-4639. Also, please note the regulation prease contact the Office or Companise to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small information on your responsionales and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers international and Colless "http://www.fda.gov/cdrh/dsma/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 {3}------------------------------------------------ NOV 0 9 2001 Indications for Use Statement K013/26 N Lp(a) Standard SY Device Name: # Indications for Use: Establishment of reference curves for the immunochemical determination of human lipoprotein(a) [Lp(a)] in serum or plasma with BN™ Systems. R. Charles for Jean Cooper vision of Clinical Laboratory Devices 510(k) Number (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) Over-The-Counter-Use (Optional Format 1-2-96)