ABX PENTRA 60 HEMATOLOGY ANALYZER

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black square with a white logo inside. The logo appears to be the letters "ALX" stylized with sharp angles and lines. The "L" is elongated and extends vertically through the other letters. The logo is simple and modern, with a bold and geometric design. OCT 1 5 1999 # Premarket Notification [510(k)] Summary - ABX Diagnostics, Inc. Company: 34 Bunsen Drive Irvine, CA 92618 Phone: (949) 453-0500 FAX: (949) 453-0600 Contact Person: Franck Brouzes Date Prepared: May 15, 1999 #### ABX PENTRA 60TM Hematology Analyzer Trade Name: | Common Name: | Automated cell counter and<br>Automated differential cell counter | |----------------------|-------------------------------------------------------------------| | Classification Name: | Automated cell counter (864.5200) and | ## Substantial Equivalence: The ABX PENTRA 60™ Hematology Analyzer is substantially equivalent to the VEGA Hematology Analyzer (K962633, cleared to market November 4, 1996). Automated differential cell counter (864.5220) #### Description: The ABX PENTRA 60™ Hematology Analyzer is a benchtop, clinical laboratory instrument which analyzes in-vitro samples of whole blood to provide complete blood count and leucocyte differential count using principles of cytochemistry, focused flow impedance and light transmission using a halogen light source. The instrument is microprocessor driven. ### Indications For Use: The ABX PENTRA 60™ Hematology Analyzer is a fully automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens. The ABX PENTRA 60™ is able to operate either in complete blood count (CBC) mode or in CBC + 5 differential leucocyte count (5DIFF) mode. #### ABX Diagnostics, Inc. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image is a black and white logo for ABX Diagnostics. The logo features the letters "ABX" in a stylized, interconnected design. Below the letters, the word "IAGNOSTICS" is written in a simple, sans-serif font. The logo is simple and modern. Comparison to Predicate Devices: The ABX PENTRA 60™ Hematology Analyzer is substantially equivalent to the already cleared device with respect to the indications for use, the hematological parameters for complete blood count and differential leucocyte count, and the principles of operation. It is different with respect to those modifications in hardware (mechanical and pneumatic) necessary to downsize the instrument, the added feature of pre-heated reagent block chambers, reduced specimen volume using a multi-distribution sampling system (MDSS), and slight changes in the reagents and the dilution ratios. The overall effect of these modifications on the safety and efficacy of the device have been evaluated in a clinical study. Software changes have been made to address the modifications and the new software has been validated. ## Discussion of Performance Data: The determination of substantial equivalence is based on an assessment on performance data on various hematological indices using human blood samples processed in the ABX PENTRA 60™ Hematology Analyzer and in the VEGA Hematology Analyzer. The human blood samples included 105 clinical specimens from patients having a normal complete blood count and 104 from patients having at least one parameter outside the normal range. Clinical samples were also used to evaluate sample stability. Assay linearity/sensitivity and carry-over were evaluated using commercially available low range and high (full) range specimens. Within-run, between-run, and between-day precision were evaluated using three commercially available control specimens having leukocvtes, erythrocvtes, platelets, and hemoglobin the low, normal and high range. ## Conclusions: Performance data on various hematological parameters comparing the ABX PENTRA 60TM Hematology Analyzer and the VEGA Hematology Analyzer, assay linearity/sensitivity and carry-over studies and within-run, between run, and between-day precision studies indicate that the ABX PENTRA 60™ is substantially equivalent to the predicate device. Prepared By: Patricia Amtower Consultant, ProMedica International {2}------------------------------------------------ Image /page/2/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 three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 OCT 1 5 1999 Mr. Frank Brouzes Vice President ABX Diagnostics, Inc. 34 Bunsen Drive Irvine, California 92618 Re: · K992511 Trade Name: ABX PENTRA 60™ Hematology Analyzer Regulatory Class: II Product Code: GKZ Dated: July 23, 1999 Received: July 27, 1999 Dear Mr. Brouzes: 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 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). 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 requirements, as set forth in the Quality System Regulation (OS) 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. {3}------------------------------------------------ ### 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/dsma/dsmamain.html". Sincerely yours, Steven Butman 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 {4}------------------------------------------------ # INDICATIONS FOR USE STATEMENT 510(k) Number (if known): K 992511 Device Name: ABX PENTRA 60™ Hematology Analyzer Indications For Use: The ABX PENTRA 60™ Hematology Analyzer is a fully automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens. The ABX PENTRA 60™ is able to operate either in complete blood count (CBC) mode or in CBC + 5 differential leucocyte count (5DIFF) mode. ## (PLEASE DO NOT WRITE BELQW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use (Per 21 CRFR 801.109)