MODIFICATION OF N PROTEIN STANDARD SL

{0}------------------------------------------------ 99/18/ JUN 1 1999 # 510(k) Summary For N Protein Standard SL ### 1. Manufacture's Name, Address, Telephone, and Contact Person, Date of Preparation: Manufacturer: Contact Information: Dade Behring Marburg GmbH Emil-von-Behring Str. 76 Marburg/Germany Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714 Attn: Carolyn K. George Tel: 302-631-6283 Preparation date: April 5, 1999 Class II (862.1150) ### Device Name/ Classification: 2. Calibrator N Protein Standard SL: Classification Number: ### 3. ldentification of the Legally Marketed Device: N Protein Standard SL (K964062) #### Device Description: 4. N Protein Standard SL is a liquid standard prepared from human serum with stabilizers and preservative. It is intended to establish reference curves for the quantitative determination of human serum proteins by immunonephelometry with the Behring Nephelometer Systems (particle-enhanced nephelometry). ### Device Intended Use: 5. Establishment of reference curves for the determination of IgG, IgG+4, IgM, C3c, C4, Transferrin, Albumin, α-antitrypsin, α-macroglobulin, Haptoglobin, α-acid glycoprotein, Prealbumin, Ceruloplasmin, RbP, Ig/L-chain lambda & kappa, ß2-microglobulin, Soluble transferrin receptor (sTfR), IgE, and Ferritin by immunonephelometry with the Behring Nephelometer Systems. ### Medical device to which equivalence is claimed and comparison information: ર. The N Protein Standard SL (modified to include sTfR) is substantially equivalent in intended use to the N Protein Standard SL (K964062) currently marketed. The N Protein Standard SL (modified), like the current N Protein Standard SL is intended to be used for the calibration of human serum protein assays on the Behring Nephelometer Systems. 00009 {1}------------------------------------------------ Dade Behring Inc. N Protein Standard SL 510(k) Notification ----- - ### Device Performance Characteristics: 7. ## Stability: Stability was evaluated according to in-house protocols and the standard was found to be Stable for at least 12 months at +2° to +8° C, as originally packaged and for at least 14 days at +2° to +8° C, once opened. # 000010 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's logo in the center. The logo consists of a stylized caduceus, which is a symbol of medicine and health. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle. " (ਰਿਰੋਰੇ JUN Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Carolyn K. George Manager, Regulatory Affairs, Biology Dade Behring Inc. P.O. Box 6101 Newark, Delaware 19714 Re: K991181 Trade Name: N Protein Standard SL: Calibrator Regulatory Class: II Product Code: JIX Dated: April 5, 1999 Received: April 7, 1999 Dear Ms. George : 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 (Premarket 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. {3}------------------------------------------------ # Page 2 Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655. 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 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Protein Standard SL 510(k) Notification # Indications for Use Statement K991181 Device Name: N Protein Standard SL # Indications for Use: Establishment of reference curves for the determination of IgG, IgG14, IgM, C3c, C4, Transferrin, Albumin, α1-antitrypsin, α2-macroglobulin, Haptoglobin, α--acid glycoprotein, Prealbumin, Ceruloplasmin, RbP, Ig/L-chain lambda & kappa, ß2microglobulin, Soluble transferrin receptor (sTfR), IgE, and Ferritin by immunonephelometry with the Behring Nephelometer Systems. Pete E. Maler (Division Sion-Division of Clinical La 510(x) Number (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) V Prescription Use (Per 21 CFR 801.109) Over-The-Counter-Use (Optional Format 1-2-96) 00000000