Hemo Control (Optional Add Pack Hemo Control DM)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K200909 FDA 510(k)
- FDA Product Code
- GKR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.5620 FDA 510(k)
- Regulation Number
- 864.5620 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Hemo Control is an automated hemoglobin analyzer designed for point-of-care testing. It provides rapid measurement of hemoglobin levels and hematocrit estimation, enabling quick clinical assessments in healthcare environments. Classified under the nomenclature for automated hemoglobin systems, it supports efficient hematology diagnostics.
This device is intended for single-use or reusable applications, depending on the components used, and is supplied as a standalone analyzer with an optional data management add-on pack. It is not explicitly stated as MRI-safe or sterile, and its regulatory status includes FDA 510(k) clearance under Special Review (K200909). Storage and usage conditions are manufacturer-specified, with connectivity options available through an optional license key for data management functionality.
Frequently asked questions
What clinical applications is the Hemo Control designed for, and how does it support point-of-care testing?
The Hemo Control is an automated hemoglobin analyzer intended for rapid measurement of hemoglobin levels and hematocrit estimation, primarily in hematology diagnostics. It is designed for point-of-care use, enabling quick clinical assessments in environments like emergency rooms, clinics, or remote healthcare settings where immediate results are critical. Its automated functionality streamlines workflows, allowing healthcare providers to make timely decisions based on hemoglobin and hematocrit values.
Is the Hemo Control single-use or reusable, and what components determine its usage type?
The Hemo Control can be used for either single-use or reusable applications, depending on the specific components utilized. The device itself is not inherently sterile, so its usability hinges on the sterility and reusability of the consumables or accessories paired with it. Always follow the manufacturer’s guidelines for proper cleaning, sterilization, and disposal to ensure safe and compliant usage.
What connectivity options are available for the Hemo Control, and how can data management be enhanced?
The Hemo Control includes optional connectivity features through an add-on pack called the Hemo Control DM. This pack requires an optional license key to enable data management functionality, allowing for integration with electronic health records (EHR) systems or other digital platforms. This enhances workflow efficiency by enabling seamless data transfer and storage for clinical or administrative use.
What regulatory pathway was followed for the Hemo Control, and what does this mean for its use in clinical settings?
The Hemo Control received FDA 510(k) clearance under Special Review (K200909), classified as substantially equivalent to a predicate device. This means the device meets FDA standards for safety and effectiveness as determined by the regulatory review process. Clinicians can rely on this clearance as evidence that the device adheres to established guidelines for automated hemoglobin analyzers, ensuring its suitability for clinical use in hematology diagnostics.
Are there specific storage or handling instructions for the Hemo Control, and what should be considered before use?
The Hemo Control’s storage and usage conditions are manufacturer-specified, meaning EKF-diagnostic GmbH provides detailed guidelines for proper handling, storage temperature, and environmental requirements. Before use, ensure the device is stored according to these specifications to maintain performance and accuracy. Additionally, verify that all consumables and accessories comply with the manufacturer’s instructions for single-use or reusable applications to avoid contamination or malfunctions.
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: Hemoglobin Analyzer - Hemo Control by EKF Diagnostics, PDF Hemo Control, EKF DIAGNOSTICS HEMO CONTROL USER MANUAL Pdf Download, Point-of-care hemoglobin analyzer - Hemo Control - EKF Diagnostics ..., Hemo Control (optional Add Pack Hemo Control DM) (K200909) — FDA 510 (k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200909 | Class II | Active |
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Manufacturer
- Manufacturer
- EKF-diagnostic GmbH
Sources (1)
- FDA 510(k) K200909 24 fields · synced Sep 19, 2026