N LP(A) CONTROL SY

{0}------------------------------------------------ # OCT 1 8 2001 ## KO13130 510(k) Summary For N Lp(a) Control SY ## Manufacturer's Name, Address, Telephone, and Contact Person, Date of 1. Preparation: Manufacturer: Dade Behring Marburg GmbH Emil-von-Behring Str. 76 Marburg/Germany Dade Behring Inc. Contact Information: Glasgow Site P.O. Box 6101 Newark, Delaware 19714 Attn: Rebecca S. Ayash Tel: 302-631-6276 Preparation date: September 14, 2001 #### Device Name/ Classification: 2. N Lp(a) Control SY: Quality Control Material (assayed) Classification Number: Class I (862.1660) #### ldentification of the Legally Marketed Device: 3. Macra Lp(a) Control (K992665) ### 4. Device Description: N Lp(a) Control SY is a lyophilized control prepared from human serum with stabilizers and preservative. It is intended to be used as an accuracy and precision control for the determination of human lipoprotein(a) [Lp(a)] by immunochemical with BN™ Systems. ### 5. Device Intended Use: The N Lp(a) Control SY is an assayed control for accuracy and precision of 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 as accuracy and precision controls for the determination of human lipoprotein(a) [Lp(a)]. One such product is the Macra Lp(a) Control, K992665. N Lp(a) Control SY, like the Macra Lp(a) Control, is intended to be used as quality control material to monitor the accuracy and precision of Lp(a) assays . 000015 {1}------------------------------------------------ ### 7. Device Performance Characteristics: ## Stability: Stability was evaluated according to Dade Behring protocols and the control 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. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three curved lines representing its body and wings. The bird is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is arranged around the circumference of the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the left side and "USA" on the right. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 OCT 1 8 2001 Ms. Kathleen Dray-Lyons Regulatory Affairs Specialist Dade Behring, Inc. Glasgow Site PO Box 6101 Newark, DE 19714 Re: k013130 > Trade/Device Name: N Lp(a) Control SY Regulation Number: 21 CFR 862.1660 Regulation Name: Ouality Control Material (Assayed and Unassayed) Regulatory Class: I, reserved Product Code: JJX Dated: September 14, 2001 Received: September 19, 2001 Dear Ms. Dray-Lyons: 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. {3}------------------------------------------------ Page 2 - This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 CFR Part 801 and v 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division 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, 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 {4}------------------------------------------------ Dade Behring Inc. N Lp(a) Control SY 510(k) Notification ## Indications for Use Statement K013130 Device Name: N Lp(a) Control SY ## Indications for Use: The N Lp(a) Control SY is an assayed control for accurancy and precision of the immunochemical determination of human lipoprotein(a) [Lp(a)] in serum or plasma with BN™ Systems. (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) Kesia Alexander-Jordan Cooper Division Sign Off oratory Devices Clinical 510(k) Number Image /page/4/Picture/13 description: The image contains the word "CONFIDENTIAL" in large, bold, black letters. The letters are slightly slanted, giving the word a dynamic appearance. The font is simple and sans-serif, making the word easily readable. 000013