OMNI C ANALYZER

{0}------------------------------------------------ K013373 NOV 0 2 2001 III. 510(k) Summary {1}------------------------------------------------ K0133373 ## NOV 0 2 2001 # 510(k) 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 | Roche Diagnostics Corporation<br>9115 Hague Rd.<br>Indianapolis, IN 46250<br>Contact Person: Jennifer Tribbett<br>Date Prepared: October 9, 2001 | | 2) Device name | Proprietary name: Omni C Analyzer<br>Common name or Classification Name: pH, Blood Gas, Electrolyte, Hematocrit, Hemoglobin and Oxygen Saturation System | | 3) Predicate device | We claim substantial equivalence to the current legally marketed Omni Modular Analyzer (K990092). | | 4) Device Description | The Omni C analyzer represents a combined blood gas, electrolyte, total hemoglobin, hematocrit and oxygen saturation test system classified as a Class II device under various sections of 21 CFR 862 and 864 based on the individual test parameters measured. | | 5) Intended use | The Roche Diagnostics Omni C Analyzer is intended to be used for the measurement of pH, PO2, PCO2, sodium, potassium, ionized calcium, chloride, hematocrit, total hemoglobin and oxygen saturation in samples of whole blood, serum, plasma and aqueous solutions as appropriate. | | | Continued on next page | : {2}------------------------------------------------ ## 510(k) Summary, Continued ### Comparison to Predicate Device | Similarities | The following is a list of some of the claims and features unaffected by the proposed modification. | |--------------|-----------------------------------------------------------------------------------------------------| |--------------|-----------------------------------------------------------------------------------------------------| | Feature/Claim | Detail | |---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use | In-vitro diagnostic device intended to measure blood gases, electrolytes, total<br>hemoglobin and hematocrit. | | Fundamental<br>Technology | For electrolytes, PO2, PCO2, pH and hematocrit the technology is the same as<br>the Omni Modular, thickfilm enzymatic and electrochemical. For the tHb/SO2<br>module, the technology is the same as the Opti R, optical reflectance. | | Sample Type | Utilizes the same sample type (whole blood, serum, plasma, aqueous buffers,<br>QC materials) for each parameters as previously cleared on the Omni Modular<br>for the electrolytes, hematocrit, PO2, PCO2 and pH and as the Opti R for<br>tHb/SO2. | | Calibration | The liquid calibration system has the same calibration principle and utilizes the<br>same calibration reagent formulations as the Omni Modular. | | Device components | Omni C utilizes the same valves and peristaltic pump as those contained within<br>the Omni Modular. | | User Interface | Omni C uses the same GUI (touch screen) as the Omni Modular, except the<br>Omni C footprint is slightly smaller. | Differences The following is a list of the claims and features affected by the proposed modification. | Feature/Claim | Detail | |-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Parameter | Incorporates a tHb/SO2 module which is not offered on the Omni Modular but<br>is a modification of the currently available Opti R tHb/SO2 module. | | Quality Control | Utilizes a different QC material due to the tHb/SO2 module. However, this<br>Quality Control formulation is based on the previously cleared OPTI-Check<br>material. | | Software | Incorporates software that functions with the tHb/SO2 module. | | Hardware features | Utilizes a new outer housing and a modified user interface to enhance the<br>intuitive features of the system. | {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wing-like shapes, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Jennifer Tribbett Regulatory Affairs Specialist Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457 NOV 0 2 2001 k013373 Re: Trade/Device Name: Omi C Analyzer Regulation Number: 21 CFR 862.1600; 21 CFR 862.1145; 21 CFR 862.1665; 21 CFR 862.1170; 21 CFR 862.1120; 21 CFR 864.5620; 21 CFR 864.5600; 21 CFR 864.7500 Regulation Name: Potassium test system; Calcium test system; Sodium test system; Chloride test system; Blood gases (P. 2, P.2) and blood pH test system; Automated hemoglobin system; Automated hematocrit instrument; Whole bood hemoglobin assays Regulatory Class: Class II; Class II; Class II; Class II; Class II; Class II; Class II; Class II Product Code: CEM; JFP; JGS; CGZ; CHL; GKR; GKF; GLY Dated: October 10, 2001 Received: October 11, 2001 Dear Ms. Tribbett: We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for the black in the 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 I ou may a 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. {4}------------------------------------------------ #### Page 2 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 or any I 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. 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 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 Part 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 Sutman 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 {5}------------------------------------------------ K013373 ### Indications for Use Statement NOV 0 2 2001 510(k) Number (if known): K0/3373 Device Name: Omni C Analyzer Indications for Use: The Roche Diagnostics Omni C Analyzer is intended to be used for the measurement of pH, PO2, PCO2, sodium, potassium, ionized calcium, chloride, hematocrit, total hemoglobin and oxygen saturation in samples of whole blood, serum, plasma and aqueous solutions as appropriate. #### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Sean Cooper (Division Sign-Off) 510/k) Numbe Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use _ (Optional Format 1-2-96) CONFIDENTIAL 015