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Citrex II

FDA 510(k)

Class II (US FDA 510(k))

510(k) K853077

by Bio/Data Corp.

Identifiers

510(k) Number
K853077 FDA 510(k)
FDA Product Code
JPA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 864.5425 FDA 510(k)
Regulation Number
864.5425 FDA 510(k)
Advisory Committee
Hematology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Citrex II is a System, Multipurpose for In Vitro Coagulation Studies, designed for hematological analysis. It functions as a platelet aggregometer and coagulation analyzer, enabling the assessment of platelet function and blood clotting mechanisms through in vitro testing. The device supports multiple coagulation assays, providing quantitative measurements of platelet aggregation and other hemostatic parameters essential for diagnostic evaluation.

This system is intended for use in clinical hematology laboratories and research settings. Supplied as a reusable medical device, it requires proper calibration and maintenance to ensure accurate results. The Citrex II adheres to FDA regulatory standards, having received FDA 510(k) clearance under the classification of Class II devices (K853077). It operates within the scope of regulation number 864.5425 and is intended for in vitro diagnostic use only, with no MRI safety considerations specified.

Frequently asked questions

What types of coagulation studies and platelet function assessments can the Citrex II perform, and why is this relevant for clinical hematology labs?

The Citrex II is designed as a multipurpose system for in vitro coagulation studies, enabling quantitative measurements of platelet aggregation and other hemostatic parameters. This makes it particularly useful for evaluating platelet function and blood clotting mechanisms, which are critical for diagnosing conditions like thrombocytopenia, bleeding disorders, or assessing the effectiveness of anticoagulant therapies. Its versatility supports multiple coagulation assays, aligning with the diagnostic needs of clinical hematology labs.

Is the Citrex II a single-use or reusable device, and what maintenance is required to ensure accurate results?

The Citrex II is supplied as a reusable medical device, meaning it is intended for repeated use in clinical or research settings. To maintain accuracy and reliability, it requires proper calibration and regular maintenance, as outlined in the manufacturer’s instructions. This ensures consistent performance for platelet aggregometry and coagulation analysis over time.

What regulatory pathway did the Citrex II follow to gain market authorization, and how does this affect its use in clinical settings?

The Citrex II received FDA 510(k) clearance under the classification of Class II devices (K853077), demonstrating it is substantially equivalent to a legally marketed predicate device. This clearance confirms it meets FDA regulatory standards for in vitro diagnostic use, ensuring its safety and effectiveness for coagulation studies and platelet function testing in clinical hematology labs and research environments.

Are there any specific storage requirements for the Citrex II, and how might this impact its handling in a laboratory?

While the provided data does not explicitly detail storage conditions, as a reusable medical device intended for precise coagulation testing, the Citrex II should be stored in a clean, controlled environment to prevent contamination or damage. Proper handling—including protection from dust, moisture, and extreme temperatures—is essential to maintain its functionality and accuracy for repeated use in clinical or research settings.

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: K853077 FDA 510(k) - CITREX II | Bio/Data Corp., Platelet Aggregometers and Aggregation Reagents | Bio/Data Corporation, PRODUCT DATA SHEETS - Bio/Data Corporation, CITREX III (K853078) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bio/Data Corp.

Sources (1)

  • FDA 510(k) K853077 24 fields · synced Sep 20, 2026