ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM

{0}------------------------------------------------ # RADIOMETER AMERICA INC. MEDICAL DIVISION CETT AKE OHIO 44146-159 B11 SHARON DRIVE, W 0600, 216-871-890 FAX 216-892-8 EXHIBIT VI ## JAN 16 1998 ﻠﺴ ﺳ #### 510(k) SUMMARY SUBJECT: - FROM: Donald L. Baker Director of Marketing and Regulatory Affairs Radiometer America Inc. 810 Sharon Drive Westlake, Ohio 44145 (440)871-8900, Ext. 287 or 1-800-736-0600 Fax (440)871-8117 - December 19, 1997 DATE: - Trade Name ABL555 PRODUCT: Common Name -Blood Gas, Electrolyte and Metabolite Measuring System Classification Name - Blood Gas #### PREDICATE - ABL555, EML105, i-STAT Model 100, and Corning 348 DEVICE: #### PRODUCT - DESCRIPTION: ABL555 is an automated blood gas, electrolyte and metabolite analyzer that is 40 cm x 55 cm x 40 cm (WHD) and weighs 37.5 kg. It measures on whole blood in approximately 54 seconds. ### INTENDED - ABL555 is a stand alone, blood gas, electrolyte and metabolite analyzer that measures pH, USE: pCO2, pO2 Na+, K+, Hct, and the option of one of the following parameters: ClT or Ca2 or glucose or lactate. #### TECHNOLOGICAL CHARACTERISTICS #### VERSUS PREDICATE ABL555 (with lactate and Hct) is technologically similar to the current version ABL555. DEVICE: #### SUBSTANTIAL EQUIVALENCE: ABL555 is substantially equivalent in features and characteristics to the current ABL555 marketed by Radiometer America Inc. (K973367). The major difference is the addition of the lactate and hematocrit. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The overall design is simple and professional, reflecting the department's role in public health and welfare. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 JAN 1 6 1998 Donald L. Baker Director of Marketing and Regulatory Affairs Radiometer America, Inc. 811 Sharon Drive Westlake, Ohio 44145-1598 K974818 Re : ABL555 Blood Gas, Electrolyte, and Metabolite Measuring System Requlatory Class: II Product Code: MMI October 30, 1997 Dated: October 31, 1997 Received: Dear Mr. Baker: 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 The general controls provisions of the Act 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 Requlations, 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 Requlation (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 In addition, FDA may publish further announcements action. 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 requlations. {2}------------------------------------------------ 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 The FDA described in your 510 (k) premarket notification. as or an your and 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 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 Gutman 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 {3}------------------------------------------------ of Page _________________________________________________________________________________________________________________________________________________________________________ 510(k) Number (if known): K974818 ABL555 Device Name:__ Indications For Use: ABLSSS is a stand alone, blood gas, electrolyte and metabolite analyzer that measures ply. The former to the Hot. and the antion of one of the following parame ABL555 is a stand alone, blood gas, electrolyte and medical responsible following parameters: PCO2, pO2 Naty K*, Hct, and the option of one of the following parameters: The f Oz that, or Glucose or Lactate. CL二 (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number 12979818 (Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use | <div style="display:flex; align-items:center;"> <span> <svg class="bi bi-check" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M13.854 3.646a.5.5 0 0 1 0 .708l-7 7a.5.5 0 0 1-.708 0l-3-3a.5.5 0 0 1 .708-.708L6.5 10.293l6.646-6.647a.5.5 0 0 1 .708 0z" fill-rule="evenodd"></path> </svg> </span> </div> (Per 21 CFR 801.109) | |----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | <div style="display:flex; align-items:center;"> <span> <svg class="bi bi-circle" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M8 15A7 7 0 1 0 8 1a7 7 0 0 0 0 14zm0 1A8 8 0 1 0 8 0a8 8 0 0 0 0 16z" fill-rule="evenodd"></path> </svg> </span> </div> | | | OR | | Over-The-Counter Use | (Optional Format 1-2-96) | - ਉ