Chrono-Log Whole Blood Lumi-Aggregometer Model 700
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K050265 FDA 510(k)
- FDA Product Code
- JOZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.5700 FDA 510(k)
- Regulation Number
- 864.5700 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Chrono-Log Whole Blood Lumi-Aggregometer Model 700 is an automated system for platelet aggregation testing, classified as a whole blood optical aggregometer. It measures platelet function by detecting changes in optical density or electrical impedance in whole blood samples while simultaneously assessing adenosine triphosphate (ATP) release during aggregation.
This device is used in hematology laboratories for research and diagnostic purposes, supplied as a reusable instrument with FDA 510(k) clearance and IVDR conformity. It operates in a controlled environment, featuring up to four channels for simultaneous testing, with temperature control and a front-panel LCD display for monitoring. Authorized under regulatory codes JOZ and 864.5700, it adheres to Class II medical device standards.
Frequently asked questions
What is the primary purpose of the Chrono-Log Whole Blood Lumi-Aggregometer Model 700 in a clinical setting?
The Chrono-Log Whole Blood Lumi-Aggregometer Model 700 is designed for platelet aggregation testing in hematology laboratories. It measures platelet function by detecting changes in optical density or electrical impedance in whole blood samples, while also assessing adenosine triphosphate (ATP) release during aggregation. This helps evaluate platelet activity, which is critical for diagnosing bleeding disorders, monitoring patients on antiplatelet therapy, or conducting research into platelet-related conditions.
How many samples can the device process simultaneously, and what features support its operation?
The Chrono-Log Whole Blood Lumi-Aggregometer Model 700 supports simultaneous testing of up to four whole blood samples. It includes temperature control to maintain optimal conditions for accurate measurements and a front-panel LCD display for real-time monitoring of aggregation results, ensuring reliable and efficient platelet function analysis.
Is the Chrono-Log Whole Blood Lumi-Aggregometer Model 700 a single-use or reusable device, and how should it be maintained?
The Chrono-Log Whole Blood Lumi-Aggregometer Model 700 is a reusable instrument, designed for long-term use in controlled laboratory environments. Since it is not single-use, proper cleaning, calibration, and maintenance protocols must be followed as per manufacturer guidelines to ensure consistent performance and sterility of disposable consumables (e.g., cuvettes or test tubes) used with the device.
What regulatory pathways has this device undergone, and what does that mean for its use?
The Chrono-Log Whole Blood Lumi-Aggregometer Model 700 has received FDA 510(k) clearance and conforms to the In Vitro Diagnostic Regulation (IVDR). This means it has been evaluated for safety and performance by regulatory authorities and is authorized for use in diagnostic and research settings within the specified classifications (Class II medical device). The clearance indicates it is considered substantially equivalent to a predicate device, ensuring it meets established standards for platelet aggregation testing.
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: CHRONO-LOG® Model 700 - Avant Medical, Chrono-Log 700 Whole Blood/Optical Lumi-Aggregometer, PDF Model 700 Whole Blood/Optical Lumi-Aggregation System
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 | K050265 | Class II | Active |
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Manufacturer
- Manufacturer
- Chrono-Log Corp
- FDA Applicant
- Chrono-Log Corp.
Sources (2)
- FDA 510(k) K050265 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026