Tetraone System for Epics Xl Flow Cytometry Systems with Cyto-Stat Tetrachrome CD45-Fitc/CD4-RD1/CD8-Ecd/CD3-PC5 Monocla

• • Terminated Z-0472-2019 FDA Class I ·initiated 12 Jan 2018

  A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or signal drifting resulting in absence of data or a population shift in the data plots. This can impact patient results for any application.

510(k) Number

K990172 ↗

FDA Product Code

GKZ

Device Class

Class II

Regulation

21 CFR Part 864.5220

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Coulter Albumin Reagent

  Class II

  FDA 510(k) K901268 Active Cleared 30 May 1990

• Coulter Ck (Creatine Kinase) Reagent

  Class II

  FDA 510(k) K901267 Active Cleared 23 May 1990

• Coulter Hdl - Cholesterol Reagent

  Class I

  FDA 510(k) K902174 Active Cleared 31 Jul 1990

• Coulter Total Bilirubin Reagent

  Class II

  FDA 510(k) K901266 Active Cleared 25 Apr 1990

• Coulter Linearity Control

  Class II

  FDA 510(k) K955334 Active Cleared 8 Feb 1996

• Immuno-Trol Control Cells

  Class II

  FDA 510(k) K984216 Active Cleared 16 Mar 1999

See all devices from Coulter Corp. →

• What clinical conditions is the TetraOne System primarily used to diagnose or monitor, and how does it help in those cases?

  The TetraOne System is designed for precise immunophenotyping of immune cell populations, particularly focusing on CD45, CD4, CD8, and CD3 markers. It is primarily used in clinical diagnostics to assess conditions like HIV (by monitoring CD4+ T-cell counts), leukemia, and other hematologic disorders. By enumerating and differentiating white blood cell subsets via flow cytometry, it provides critical data for immune system evaluation, aiding in disease monitoring, treatment planning, and patient management.

• Is the TetraOne System reusable, and if so, what about the reagents used with it?

  Yes, the TetraOne System itself is a reusable flow cytometry platform. However, the reagents—specifically the Cyto-Stat Tetrachrome CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 monoclonal antibodies—are supplied as single-use kits. This design ensures consistency and sterility for each test while allowing the core instrument to be used repeatedly across multiple analyses.

• How should the reagent kits for the TetraOne System be stored, and why is this important?

  The reagent kits for the TetraOne System require refrigeration as specified by the manufacturer. Proper refrigeration is critical to maintain the stability and efficacy of the fluorescently labeled monoclonal antibodies, ensuring accurate and reliable immunophenotyping results. Failure to follow storage guidelines could compromise reagent integrity and lead to inaccurate diagnostic outcomes.

• What regulatory pathways has the TetraOne System undergone, and what does this mean for its use in clinical settings?

  The TetraOne System has undergone FDA 510(k) clearance (K990172) and complies with In Vitro Diagnostic Device Regulations (IVDD/IVDR). This means it has been evaluated for safety and performance by regulatory authorities and is classified as a Class II medical device under regulation number 864.5220. Clinically, this indicates it meets established standards for use in hematological analysis, providing assurance of its reliability for diagnosing and monitoring immune-related conditions in accredited laboratories.