Bc-3200 Auto Hematology Analyzer, M-30d Diluent, M-30r Rinse, M-30cfl Lyse, M-3…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K093394 FDA 510(k)
- FDA Product Code
- GKZ 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 BC-3200 Auto Hematology Analyzer is a Counter, Differential Cell device, designed for automated hematological analysis. It performs quantitative measurements of blood parameters, including red blood cells, white blood cells, hemoglobin, and platelet counts, with differential leukocyte analysis to identify cell types.
This system is intended for use in clinical laboratories and healthcare settings, operating with single-use consumables such as diluents, rinses, and lyse reagents. The analyzer requires compatible accessories for maintenance, including cleansers for probes and general system care. Authorized under FDA 510K and IVDD/IVDR, it adheres to Device Class II regulations (Regulation Number 864.5220) and is supplied with specific model codes for identification and compliance.
Frequently asked questions
What types of blood parameters does the BC-3200 Auto Hematology Analyzer measure, and how does it differentiate cell types?
The BC-3200 performs quantitative measurements of key blood parameters including red blood cells (RBCs), white blood cells (WBCs), hemoglobin levels, and platelet counts. It also includes differential leukocyte analysis, which automatically identifies and counts specific types of white blood cells (e.g., neutrophils, lymphocytes, monocytes) for a detailed breakdown of the patient’s immune cell profile.
Are the consumables (e.g., diluents, lyse reagents) single-use, and if so, how does this impact workflow?
Yes, the BC-3200 operates exclusively with single-use consumables like the M-30D Diluent, M-30CFL Lyse reagent, and M-30R Rinse. This design eliminates cross-contamination risks and reduces maintenance downtime, as each sample requires fresh reagents. The system is engineered to streamline workflow by minimizing manual cleaning steps between tests.
What maintenance accessories are required for the BC-3200, and how do they differ in function?
The analyzer requires specialized maintenance accessories to preserve performance and sterility: the M-30E-Z Cleanser for general system disinfection, the M-30Probe Cleanser for probe-specific care, and the BC-3D C (likely a cleaning cartridge). These products target different components—cleansers remove residue from surfaces, while the probe cleanser ensures accurate readings by maintaining sample site integrity.
How is the BC-3200’s regulatory compliance demonstrated, and which standards apply to its use?
The BC-3200 holds FDA 510(k) clearance (K093394) and complies with In Vitro Diagnostic Device Directives (IVDD/IVDR) under EU regulations. It falls under Device Class II (Regulation Number 864.5220) for hematology analyzers, indicating it meets stringent performance and safety criteria for automated blood cell counting in clinical settings. The product code GKZ further categorizes it for regulatory tracking.
Does the analyzer support multiple models or configurations, and how might this affect consumable compatibility?
The BC-3200 is listed with multiple model codes (e.g., M-30D, M-30R) to denote specific consumables or accessories. While the core analyzer hardware remains consistent, these codes ensure compatibility with the correct reagents or maintenance items. Clinicians should verify the exact model code (e.g., M-30D for diluent) to confirm consumable pairing, as mismatches could lead to inaccurate results or system errors.
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: BC-3200 AUTO HEMATOLOGY ANALYZER,M-30D DILUENT, M …, Bc-3200 Auto Hematology Analyzer,m-30d Diluent, M-30r Rinse, M …, BC-3200 AUTO HEMATOLOGY ANALYZER,M-30D DILUENT, M …, DM-30D Diluent - DIAGON, K093394 BC-3200 AUTO HEMATOLOGY ANALYZER,M-30D …
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Active |
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K093394 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Sources (2)
- FDA 510(k) K093394 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026