Coulter Ac T Diff 2 Analyzer

• • Terminated Z-0339-05 FDA Unclassified (pre-2012) ·initiated 3 Dec 2004

  Erroneous results issue when MONOJECT blood collection tubes are used during analysis after tubes are uncapped and recapped then analysed in the closed vial mode. Results are lower than if cap had not been removed.

510(k) Number

K990352 ↗

FDA Product Code

GKZ

Device Class

Class II

Regulation

21 CFR Part 864.5220

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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See all devices from Coulter Corp. →

• What is the Coulter AC-T DIFF 2 Analyzer used for?

  The Coulter AC-T DIFF 2 Analyzer is a hematology instrument designed to perform automated differential white blood cell counts and complete blood counts (CBCs). It uses Coulter’s histogram differential technology to analyze and classify blood cell populations, providing detailed hematological data for diagnostic purposes in clinical settings. This makes it particularly useful for laboratories, including physician office labs and smaller facilities, to efficiently process up to 50 CBCs daily.

• How is the Coulter AC-T DIFF 2 Analyzer supplied and intended for use?

  The Coulter AC-T DIFF 2 Analyzer is supplied as a reusable device. It is intended for use in clinical laboratories, including smaller facilities and physician office labs, where it can perform up to 50 complete blood counts (CBCs) daily. Its flexibility includes operation in both open and closed analysis modes, accommodating various laboratory workflows.

• Is the Coulter AC-T DIFF 2 Analyzer single-use or reusable?

  The Coulter AC-T DIFF 2 Analyzer is designed as a reusable device. This means it is built to withstand repeated use in clinical settings, provided it is properly maintained and cleaned according to manufacturer guidelines. Reusability helps reduce costs and waste while ensuring consistent performance for laboratories.

• Does the Coulter AC-T DIFF 2 Analyzer require any specific storage conditions?

  The provided data does not specify any particular storage conditions for the Coulter AC-T DIFF 2 Analyzer. However, as a reusable medical device, it should be stored in a clean, dry environment, protected from dust, moisture, and extreme temperatures to maintain its functionality and ensure longevity. Always follow the manufacturer’s instructions for optimal storage and handling.

• What regulatory pathway does the Coulter AC-T DIFF 2 Analyzer follow?

  The Coulter AC-T DIFF 2 Analyzer holds an FDA 510(k) clearance under the traditional pathway. It is classified as a Class II device under the product code GKZ and falls under the regulatory coverage of 21 CFR 864.5220. This classification indicates that it has been determined to be substantially equivalent to a predicate device already on the market, ensuring it meets established safety and performance standards.