Cellavision Dm1200 With The Body Fluid Appliction
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K102778 FDA 510(k)
- FDA Product Code
- JOY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.5260 FDA 510(k)
- Regulation Number
- 864.5260 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The CellaVision DM1200 with Body Fluid Application is an Automated Cell-Locating Device (Device Class II) designed for hematology. It automates the analysis of blood and body fluid samples by using high-speed robotics and digital imaging to capture and classify cellular morphology, enabling standardized differential counts and review processes.
This system is intended for use in clinical hematology laboratories and is supplied as a reusable medical device. It is approved under the FDA 510(k) clearance and In Vitro Diagnostic Regulation (IVDR). The device requires appropriate training for operation and must be maintained in accordance with manufacturer guidelines to ensure accurate and reliable performance.
Frequently asked questions
What types of samples can the CellaVision DM1200 with Body Fluid Application analyze, and how does it differ from traditional hematology methods?
The CellaVision DM1200 is designed to analyze both blood and body fluid samples, automating cellular morphology assessment through high-speed robotics and digital imaging. Unlike traditional manual microscopy or basic automated hematology analyzers, it provides standardized differential counts and detailed cell classification, improving accuracy and efficiency in identifying abnormalities in clinical hematology laboratories.
Is the CellaVision DM1200 a single-use or reusable device, and what maintenance is required to ensure reliable performance?
The CellaVision DM1200 is a reusable medical device, meaning it is built for repeated use in clinical settings. To maintain accuracy and reliability, it requires proper training for operation and adherence to the manufacturer’s maintenance guidelines, which likely include regular cleaning, calibration, and software updates to ensure optimal performance over time.
What regulatory approvals does the CellaVision DM1200 hold, and how does this affect its use in clinical settings?
The device holds FDA 510(k) clearance and In Vitro Diagnostic Regulation (IVDR) compliance, confirming its safety, performance, and equivalence to predicate devices in automated cell-locating technology. This approval allows its use in clinical hematology laboratories in the U.S. and EU markets, provided operators follow manufacturer instructions and regulatory requirements for proper implementation.
Does the CellaVision DM1200 come with any specific accessories or consumables, and are they included in the initial purchase?
The device is supplied as a reusable system, but its operation likely requires compatible consumables such as slides, coverslips, or staining reagents for sample preparation. While the base unit itself is reusable, the manufacturer may offer optional accessories or consumable kits—details should be confirmed with the supplier or manufacturer, as these are not explicitly listed in the provided data.
How does the Body Fluid Application feature expand the device’s utility compared to standard hematology analyzers?
The Body Fluid Application extension enables the CellaVision DM1200 to analyze non-blood samples like cerebrospinal fluid, pleural fluid, or synovial fluid, which traditional hematology analyzers may not handle effectively. This feature broadens its clinical utility by providing standardized cellular analysis for diagnostic purposes beyond routine bloodwork, supporting a wider range of hematology assessments.
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: CellaVision® DM1200, CellaVision® Body Fluid Application, CellaVision® DM1200 Digital Cell Morphology System - HORIBA
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K102778 | Class II | Active |
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Manufacturer
- Manufacturer
- Cellavision AB
Sources (2)
- FDA 510(k) K102778 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026