ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS

{0}------------------------------------------------ ### 510(k) Summary (Summary of Safety and Effectiveness) K103627 This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. OCT 1 4 2011 #### Applicant Name: Judith Wallach, Regulatory Affairs Administrator Regulatory Affairs Abbott Laboratories Diagnostics Division Dept. 9V6, AP6C-2 100 Abbott Park Road Abbott Park, IL 60064 Phone and fax numbers 847-937-1132, FAX 847-937-4836 Date prepared October 12, 2011 ### Device Name: #### Reagent Kit Classification Name: Carbamazepine test system Trade Name: ARCHITECT iCarbamazepine Common Name: Carbamazepine Governing Regulation: 862.3645 Device Classification: Class II Classification Panel: Clinical Toxicology Code: KLT # ARCHITECT iCarbamazepine Calibrator Kit Classification Name: Calibrators, Drug Specific Trade Name: ARCHITECT iCarbamazepine Common Name: Calibrator {1}------------------------------------------------ Governing Regulation: 862.3200 Device Classification: Class II Classification Panel: Clinical Toxicology Code: DLJ # Legally marketed device to which equivalency is claimed: AxSYM Carbamazepine (K935374) ## Intended Use of the Device The ARCHITECT iCarbamazepine assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of carbamazepine, an anticonvulsant drug, in human serum or plasma (collected in lithium heparin, sodium heparin, dipotassium EDTA or sodium EDTA tubes) on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used in monitoring levels of carbamazepine to help ensure appropriate therapy. ## Description of Device The ARCHITECT iCarbamazepine assay is a one-step immunoassay for the quantitative measurement of carbamazepine in human serum or plasma using CMIA technology with flexible assay protocols referred to as Chemiflex. In the ARCHITECT iCarbamazepine assay, sample, anti-carbamazepine coated paramagnetic microparticles, and carbamazepine acridinium-labeled conjugate are combined to create a reaction mixture. The anti-carbamazepine coated microparticles bind to carbamazepine present in the sample and the carbamazepine acridinium-labeled conjugate. After washing, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An indirect relationship exists between the amount of carbamazepine in the sample and the RLUs detected by the ARCHITECT i System optics. # Comparison of Technological Characteristics: The ARCHITECT iCarbamazepine assay utilizes chemiluminescent microparticle immunoassay (CMIA) technology for the quantitative measurement of carbamazepine, an anticonvulsant drug, in human serum or plasma. The AxSYM Carbamazepine assay utilizes Fluorescence Polarization Immunoassay (FPIA) technology for the quantitative measurement of carbamazepine, an anticonvulsant drug, in serum or plasma. ## Summary of Analytical Performance: The ARCHITECT iCarbamazepine assay is substantially equivalent to the AxSYM Carbamazepine assay in terms of analytical performance data in this 510(k) submission. {2}------------------------------------------------ The analytical performance of the ARCHITECT iCarbamazepine assay was demonstrated through the following studies, which are provided in this 510(k) submission: - Precision - · Sensitivity (Limit of Blank, Limit of Detection, and Limit of Quantitation) - · Linearity - Interferences - Recovery - Manual Dilution - · Matrix Comparison (Tube Type) - · Method Comparison (Correlation) {3}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized bird-like symbol in the center. The text around the circle appears to be the name of an organization or agency. The bird-like symbol is composed of curved lines, giving it a sense of movement or flight. The logo has a simple, clean design, with a focus on conveying a sense of professionalism and purpose. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Abbott Laboratories c/o Ms. Judith Wallach Regulatory Affairs Administrator Dept. 9V6. AP6C-2 100 Abbout Park Road Abbott Park. II. 60064 001 1 4 2011 Re: k103627 Trade/Device Name: Architect iCarbamazepine Immunoassay Regulation Number: 21 CFR 862.3645 Regulation Name: Carbamazepine test system Regulatory Class: Class II Product Code: KLT, DKB Dated: October 12, 2011 Received: October 13. 2011 Dear Ms. Wallach 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). {4}------------------------------------------------ Page 2 - If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, 'Misbranding by reference to premarket notification'' (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 30) ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, signature Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # Indications for Use Form 510(k) Number (if known): _ k 1 0 3 4 2 7 Device Name: ARCHITECT iCarbamazepine Indications for Use: #### Reagents : The ARCHITECT iCarbamazepine assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of carbamazepine, an anticonvulsant drug, in human serum or plasma (collected in lithium heparin, sodium heparin, dipotassium EDTA or sodium EDTA tubes) on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used in monitoring levels of carbamazepine to help ensure appropriate therapy. #### Calibrators : The ARCHITECT iCarbamazepine Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative measurement of carbamazepine, an anticonvulsant drug, in human serum or plasma. X Prescription Use Over-The-Counter Use Preschplion Ose (Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Rute Claren Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) (0 3 6 2 ]