ABX Pentra 60 Hematology Analyzer

• • Terminated Z-0039-04 FDA Unclassified (pre-2012) ·initiated 8 Sep 2003

  Samples with high fat content will not count platelets accurately.

510(k) Number

K992511 ↗

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

• Pentra 80

  Class II

  FDA 510(k) K024002 Active Cleared 3 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

See all devices from Abx Diagnostics →

• What types of blood tests can the ABX Pentra 60 Hematology Analyzer perform, and how does it classify white blood cells?

  The ABX Pentra 60 performs complete blood counts (CBC) and five-part leukocyte differentials. It classifies white blood cells using cytochemistry and light absorbency, which helps distinguish between different types of leukocytes for accurate diagnostic results.

• Is the ABX Pentra 60 Hematology Analyzer designed for single-use or reusable applications, and what maintenance does it require?

  The ABX Pentra 60 is a reusable medical device, meaning it is intended for repeated use in clinical settings. Like all reusable devices, it requires proper calibration and maintenance as outlined by the manufacturer to ensure accurate and reliable performance over time.

• What regulatory pathway was followed for the FDA clearance of the ABX Pentra 60 Hematology Analyzer?

  The ABX Pentra 60 received FDA clearance through a 510(k) premarket notification, specifically under the Traditional 510(k) review pathway. It was determined to be substantially equivalent to a predicate device and falls under Class II regulatory classification for hematology analyzers.

• How is the ABX Pentra 60 intended to be integrated into a clinical workflow, and what connectivity does it offer?

  The ABX Pentra 60 is designed as a standalone instrument for clinical laboratories and healthcare settings. It connects to a PC for data management, allowing seamless integration into existing workflows for automated hematological analysis and result reporting.