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MAR I 0 ?0n4 K\O+O/ 31I 510(k) Summary - Tina-quant IgM Gen.2 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 Submitter name, address, contact Roche Diagnostics 9115 Hague Rd Indianapolis IN4 46250 (317) 521-383 1 Contact person: Sherri L. Coenen Date prepared: February 17, 2004 Device Name Proprietary name: Roche Diagnostics Tina-quant IgM Gen.2 Common name: Tina-quant IgM Gen.2 Classification name: IgM (Mu chain specific) antigen, antiserum, control Device description The Tina-quant IgM Gen.2 is an immunoturbidimetric assay. Anti-IgM antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically. Intended use Immunoturbidimetric assay for the quantitative in vitro determination of IgM in human serum and plasma on Roche automated clinical chemistry analyzers. Predicate Device We claim substantial equivalence to the currently marketed Roche Diagnostics T'Ina-quant IgM assay. (K955908). 22 510(k) Summary - Tina-quant IgM Gen.2, Reagent Summary Topic Intended Use Method Sample type Measuring range Expected values continued The following table describes the similarities and differences between the Tina-quant IBM Gen.2 and the predicate device. Tina-quant IgM (K955908) Immunoturbidimetric assay for the quantitative in vitro determination of IgM in human serum and plasma on automated clinical chemistry analyzers. Immunoturbidimetric assay Serum Plasma: Herarin, EDTA Roche/Hitachi 902: 30 - 490 mg/dL Roche/Hitachi 904/911/912/917/Modular: 25 - 650 mg/dL 3 - 5362 mg/dL with rerun 40 - 230 mg/dl Tina-quant IgM Gen.2 (Modified Device) Same Same Same StandardApplication: Roche/Hitachi 902: 25 - 650 mg/dL Roche/Hitachi 904/911/912/917/Modular: 25 - 650 mg/dL 3 - 3660 mg/dL with rerun Sensitive Application: Roche/Hitachi 902: 4 - 150 mg/dL Roche/Hitachi 904/911/912/917/Modular: 4 - 150 mg/dL 1 - 450 mg/dL with rerun Adults: 40 - 230 mg/dL Additional ranges for children 0 - 19 years 23 DEPARTMENT OF HEALTH & HUMAN SERVICES o -~ MvIAR I C20192098 Food and Drug Administration Gaither Road Rockville MD 20850 Ms. Sherri L. Coenen Regulatory Submissions, Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457 Re: k040431 Trade/Device Name: Roche Diagnostics Tina-quant IgM Gen.2 Regulation Number: 21 CFR § 866.5550 Regulation Name: Irrnunoglobulins (Light Chain Specific) Immunological Test System Regulatory Class: II Product Code: DAO Dated: February 17, '2004 Received: February 19, 2004 Dear Ms. Coenen: 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 reclas:sified 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 determ:ination 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 recquirements, 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). This letter will allow you to begin marketing your device as described in your Section 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. Page 2 If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmzfdsmamain.html. Sincerely yours, Joseph L. Hackett, Ph.D. Acting Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure Indications for Use Statement 510(k)Number(ifknown): N_ _KIO4qIO~l Device Name: Tina-qint 1M Gen2 Indications For Use: Immmumotibidimetric assay for the quaotitative in vitro determination of IgM in human serum and plasma on Roche automated clinical chemistry analyzers. Measurement aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. (PLEASE DO NOT WRITE' BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use _ OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96) Di"ision Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) fi(° /o- 20