Pentra 80

• 2 recalls, same reason

  • Terminated Z-0003-05 FDA Unclassified (pre-2012) ·initiated 13 Aug 2004
  • Terminated Z-0002-05 FDA Unclassified (pre-2012) ·initiated 13 Aug 2004

  Device can generate overestimated platelet results.

510(k) Number

K024002 ↗

FDA Product Code

GKZ

Device Class

Class II

Regulation

21 CFR Part 864.5220

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Abx Micros 60 Hematology Analyzer

  Class II

  FDA 510(k) K014203 Active Cleared 28 Feb 2002

• Modification to Pentra 60 and Pentra 60C+

  Class II

  FDA 510(k) K030144 Active Cleared 31 Jan 2003

• Abx Micros Crp

  Class II

  FDA 510(k) K002646 Active Cleared 26 Oct 2000

• Abx Pentra 120 Retic Automated Hematology Analyzer

  Class II

  FDA 510(k) K991839 Active Cleared 11 Aug 1999

• Abx Pentra 60C+ Hematology Analyzer

  Class II

  FDA 510(k) K003677 Active Cleared 26 Dec 2000

• ABX Pentra 60 Hematology Analyzer

  Class II

  FDA 510(k) K992511 Active Cleared 15 Oct 1999

See all devices from Abx Diagnostics →

• What is the Pentra 80 used for in clinical settings?

  The Pentra 80 is an automated hematology analyzer designed to perform a complete blood count (CBC) and white blood cell differential. It provides essential diagnostic measurements for evaluating blood disorders, including red blood cell, white blood cell, and platelet parameters. This makes it a critical tool for hematology labs assessing patients for conditions like anemia, infections, or clotting disorders.

• Is the Pentra 80 supplied as a single-use or reusable device?

  The Pentra 80 is supplied as a reusable medical device. Unlike single-use instruments, it is intended for repeated use in clinical laboratory settings, provided it undergoes proper maintenance, calibration, and cleaning as outlined in the manufacturer’s technical manuals. This design supports cost efficiency and consistent performance over time.

• Does the Pentra 80 come pre-sterilized or require sterilization before use?

  The Pentra 80 is not specified as sterile, meaning it is not pre-sterilized for immediate use. Clinicians must follow standard sterilization protocols and manufacturer guidelines to ensure the device is properly cleaned and prepared for patient testing. This aligns with typical practices for reusable medical devices in hematology.

• What regulatory pathway does the Pentra 80 follow in the U.S.?

  The Pentra 80 received FDA clearance through a 510(k) submission (K024002) under the Special classification for hematology devices. This pathway confirms that the device is substantially equivalent to a legally marketed predicate device, ensuring it meets U.S. regulatory standards for Class II medical devices. The authorization is filed under regulation number 864.5220.

• Are there different models or sizes available for the Pentra 80?

  The provided data does not specify multiple models or sizes for the Pentra 80. It is described as a singular automated hematology analyzer intended for general use in clinical laboratories. For specific configurations or accessories, users should refer to the manufacturer’s documentation or contact Abx Diagnostics directly.