Glocyte Automated Cell Counter System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K152776 FDA 510(k)
- FDA Product Code
- GKL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.5200 FDA 510(k)
- Regulation Number
- 864.5200 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Glocyte Automated Cell Counter System is an in vitro diagnostic device designed for the quantitative determination of fluorescence-labeled total nucleated cells and erythrocytes in cerebrospinal fluid. It is intended for use by trained healthcare professionals in clinical laboratories to support the analysis of CSF samples from adult and pediatric patients.
The system includes the Glocyte instrument and operates using advanced fluorescence technology, specific reagents, and dynamic algorithms to automate cell counting. It is supplied as a complete system for laboratory use and is regulated under FDA 510(k) authorization with product code GKL. The device is classified as a Class II automated cell counter under regulation 864.5200 and is intended for in vitro diagnostic use only.
Frequently asked questions
What types of cells does the Glocyte system count in cerebrospinal fluid?
It measures both total nucleated cells and erythrocytes that have been labeled with a fluorescent dye. The fluorescence signal allows the instrument’s algorithms to differentiate and enumerate each cell type accurately, which is essential for diagnosing infections or hemorrhage in CSF samples.
Is the Glocyte system supplied as a complete unit or as separate components?
The device is provided as a complete system that includes the instrument, required reagents, and software. Supplying it as a turnkey solution ensures that laboratories have all necessary parts for immediate implementation and reduces the risk of missing critical components.
Can the Glocyte counter be used for both adult and pediatric CSF samples?
Yes, the system is intended for use with cerebrospinal fluid from both adult and pediatric patients. Its dynamic algorithms and fluorescence detection are calibrated to handle the wide range of cell concentrations typically encountered across age groups.
What regulatory pathway was used for the Glocyte system’s market clearance?
The Glocyte Automated Cell Counter System received FDA 510(k) clearance under product code GKL, classified as a Class II in‑vitro diagnostic device. This pathway required demonstration of substantial equivalence to a legally marketed predicate device.
What training is required for personnel operating the Glocyte system?
The device is intended for use by trained healthcare professionals in clinical laboratories. Operators must be familiar with fluorescence‑based assays, sample preparation for CSF, and the instrument’s software to ensure accurate cell counts and maintain compliance with laboratory standards.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: GloCyte® Automated Cell Counter for CSF - Advanced instruments, GloCyte® | Nova Biomedical, Advanced Instruments GloCyte® Automated Cell Counter System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K152776 | Class II | Active |
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Manufacturer
- Manufacturer
- Advanced Instruments, Inc.
Sources (1)
- FDA 510(k) K152776 24 fields · synced Sep 26, 2026