PRECINORM TDM CONTROLS

{0} K971060 JUL - 7 1997 # BOEHRINGER MANNHEIM CORPORATION ## Summary ### Introduction According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. ### 1. Submitter name, address, contact Boehringer Mannheim Corporation 2400 Bisso Lane Concord, CA 94524-4117 (510) 674-0690 extension 8413 Fax number: (510) 687-1850 Contact Person: Yvette Lloyd Date Prepared: March 20, 1997 ### 2. Device Name Proprietary name: Precinorm® TDM Controls Common name: Controls Classification name: Single (specified) analyte controls (assayed + unassayed) ### 3. Predicate device The Boehringer Mannheim Precinorm® TDM Controls are substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the Baxter Dade® IAC-X Comprehensive Immunoassay Control (K912455). ### 4. Device Description The Boehringer Mannheim Precinorm® TDM Controls are manufactured using human serum albumin, therapeutic drugs, stabilizers, and preservatives. The analytes are appropriately spiked into the control matrix to the correct control concentration levels. The controls are in process checked, and a value assignment process is done via a comparison to an analyte specific (and chemistry specific) calibrator. Continued on next page {1} BOEHRINGER MANNHEIM CORPORATION Summary, Continued  5. Intended use The Boehringer Mannheim Precinorm® TDM Controls are used to monitor accuracy and precision. 6. Comparison to predicate device The Boehringer Mannheim Precinorm® TDM Controls are substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the Baxter Dade® IAC-X Comprehensive Immunoassay Control (K912455). The following table compares the Boehringer Mannheim Precinorm® TDM Controls with the predicate device, the Baxter Dade® IAC-X Comprehensive Immunoassay Controls. Specific data on the performance of the controls have been incorporated into the draft labeling in attachment 5. Labeling for the predicate devices are provided in attachment 6. Similarities: - Similar intended use - Similar matrix - Similar stability claims - Both are tri-level Continued on next page page 26 {2} 510(k) Summary, Continued Differences: | Feature | Precinorm® TDM Control | Baxter-Dade® Immunoassay Control | | --- | --- | --- | | Analytes | T4, T-Uptake, T3, Amikacin, Carbamazepine, Hydrocortisone (Cortisol), Quinidine, Digoxin, Digitoxin, Disopyramide, Ethosuximide, Gentamicin, Lidocaine, Phenobarbital, Phenytoin, Primidone, Procainamide, N-acetylprocainamide, Theophylline, Tobramycin, Valproic Acid, Methotrexate, Chloramphenicol, Salicylic Acid, Lithium, Acetaminophen, Propanolol, Vancomycin, and Streptomycin. | Acetaminophen, Alpha-Fetoprotein (AFP), Aldosterone, Amikacin, Carbamazepine, Carcinoembryonic Antigen (CEA), Cortisol, Cyclosporine, Digoxin, Disopyramide, Estradiol, Ethosuximide, Ferritin, Folate, Free T3, Free T4, Follicle Stimulating Hormone (FSH), Gentamicin, Human Chorionic Gonadotropin, (hCG), Human Growth Hormone (hGH), Human Luteinizing Hormone (hLH), Immunoglobulin E (IgE), Insulin, Iron Binding Capacity, Lidocaine, Lithium, N-acetylprocainamide (NAPA), Prostatic Acid Phosphatase (PAP), Phenobarbital, Phenytoin, Primidone, Procainamide, Progesterone, Prolactin, Prostate Specific Antigen (PSA), Parathyroid Hormone (PTH), Quinidine, Salicylate, Serum Iron, Tricyclic Antidepressants (TCA), Testosterone, Theophylline, Thyroid Uptake/T3 Uptake, Tobramycin, Total T3, Total T4, TSH, Valproic Acid, Vancomycin, Vitamin B12 | | Reconstitution Instructions | Add 3 mL of distilled water, then let sit for 30 minutes, with occasional swirling. | Add 5 mL of distilled or deionized water, then let stand at room temperature for 10 minutes. | Continued on next page {3} BOEHRINGER MANNHEIM CORPORATION Summary, Continued 6. Comparison to predicate device, (cont.) Performance Characteristics: - Dose assignment and stability: equivalent performance to the predicate device. page 28 {4} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Yvette R. Lloyd - Regulatory Affairs Specialist Boehringer Mannheim Corporation 2400 Bisso Lane P.O. Box 4117 Concord, California 94524-4117 Re: K971060 Precinorm™ TDM Controls Regulatory Class: I Product Code: DIF Dated: June 20, 1997 Received: June 23, 1997 JUL - 7 1997 Dear Ms. Lloyd: 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 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 requirement, 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. {5} 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/dsmamain.html". Sincerely yours, 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 {6} page 24 Office Name: Precinorm® TDM Control. Locations For Use: Precinorm® TDM is a triple range lyophilised control material based on human serum. Precinorm® TDM is used for monitoring accuracy or precision. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)  Description Use: ☑ 21 CFR 801.109) OR Over-The-Counter Use ☐ (Optional Format 1-2-96)