BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configura…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K201814 FDA 510(k)
- FDA Product Code
- OYE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.5220 FDA 510(k)
- Regulation Number
- 864.5220 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BD FACSLyric Flow Cytometer is a flow cytometric reagent and accessory system designed for immunophenotyping. It combines multiple optical configurations (3-1, 4-2, 4-2-2, 4-3-3, and 4-3-5) with up to six fluorescence detection channels and two light scatter channels, utilizing blue (488-nm) and red (640-nm) lasers to analyze cellular characteristics. The system includes automated sample preparation capabilities for human peripheral whole blood, enabling precise immunophenotyping assays. Optional components such as the BD FACSDuet Sample Preparation System and BD FACS Universal Loader enhance workflow efficiency and sample handling.
The BD FACSLyric Flow Cytometer is supplied as a modular system with configurable optical configurations, software (BD FACSuite Clinical), and consumables, including sheath fluid, calibration/control beads, and assay modules. It is intended for use in hematology settings and is regulated under FDA 510(k) clearance (K201814) as a Class II device (OYE). The system is designed for in vitro diagnostic use, with components such as the BD FACSDuet Sample Preparation System and BD Multitest Assay Modules intended for automated sample processing and immunophenotyping. Storage and handling follow standard IVD protocols, with consumables provided as single-use items.
Frequently asked questions
What types of samples can the BD FACSLyric Flow Cytometer analyze, and how does the automated sample preparation system assist in this process?
The BD FACSLyric Flow Cytometer is designed specifically for immunophenotyping of human peripheral whole blood. The included BD FACSDuet Sample Preparation System automates sample processing, which streamlines workflows by handling lysis, washing, and staining steps—reducing manual intervention and improving consistency for hematology applications.
Are the consumables like sheath fluid, assay modules, and calibration beads single-use, and how should they be stored?
Yes, all consumables—including BD FACSFlow Sheath Fluid, BD Multitest Assay Modules, BD CS&T Beads, and the BD FC Beads 7-Color Kit—are intended for single-use only. They should be stored according to standard in vitro diagnostic (IVD) protocols, typically at room temperature or refrigerated (as specified on individual packaging) to maintain performance and sterility until use.
What optical configurations are available for the BD FACSLyric Flow Cytometer, and how do they impact its functionality?
The BD FACSLyric offers five modular optical configurations: 3-1, 4-2, 4-2-2, 4-3-3, and 4-3-5. These configurations determine the number of fluorescence detection channels (up to six) and light scatter channels (two), enabling flexibility for different immunophenotyping assays. For example, the 4-3-5 configuration provides the highest channel capacity, ideal for complex multi-color staining workflows.
How does the BD FACSuite Clinical software integrate with the hardware, and what role does it play in data analysis?
The BD FACSuite Clinical software is designed to work seamlessly with the BD FACSLyric Flow Cytometer, providing tools for data acquisition, gating strategies, and immunophenotyping analysis. It automates key workflow steps—such as compensation setup and event acquisition—while offering clinical reporting features tailored for hematology applications, ensuring standardized and reproducible results.
What is the regulatory pathway for this device, and how does it relate to its use in hematology settings?
The BD FACSLyric Flow Cytometer is cleared by the FDA under a 510(k) submission (K201814) as a Class II device, with a product code of OYE. This clearance confirms its substantial equivalence to a predicate device and establishes its regulatory compliance for in vitro diagnostic use in hematology settings, where immunophenotyping is critical for diagnosing and monitoring blood-related conditions.
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: PDF BD FACSLyric Technical Specifications, PDF BD FACSLyric Flow Cytometry System US Product List IVD, BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201814 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K201814 24 fields · synced Oct 6, 2026