Aggro/Link vW Cofactor Software
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K940792 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 Aggro/Link vW Cofactor Software is an automated platelet aggregation system designed for hematological analysis. It facilitates the assessment of von Willebrand factor (vWf) activity and platelet function by simulating aggregometry tests, aiding in the diagnosis and monitoring of bleeding disorders such as von Willebrand disease.
This software is intended for use in clinical laboratories and research settings, operating as part of an automated platelet aggregation system. Supplied as a digital solution, it requires compatibility with the manufacturer’s hardware and is classified under FDA regulation 864.5700. The device holds a 510(k) clearance (K940792) and is categorized as a Class II medical device, adhering to hematology-specific standards for platelet function testing.
Frequently asked questions
What clinical conditions can the Aggro/Link vW Cofactor Software help diagnose or monitor?
The software is designed to assist in diagnosing and monitoring bleeding disorders, specifically von Willebrand disease, by simulating platelet aggregation tests. It measures von Willebrand factor (vWf) activity and platelet function, which are critical for evaluating coagulation disorders in clinical and research settings.
Is this software compatible with any specific hardware, and how is it supplied?
The Aggro/Link vW Cofactor Software is a digital solution that requires compatibility with Chrono-Log Corp.’s automated platelet aggregation system hardware. It is supplied as a standalone software component, not as a physical device, and must be integrated with the manufacturer’s designated equipment for operation.
Where can this software be used, and what type of environment is it intended for?
This software is intended exclusively for use in clinical laboratories and research settings. It is not designed for point-of-care or home use but rather for specialized hematological analysis where precise platelet function and vWf activity assessments are required.
How is the regulatory status of this software defined, and what does that mean for users?
The software holds a 510(k) clearance (K940792) from the FDA, meaning it has been determined to be substantially equivalent to a legally marketed device in terms of technology and safety. This classification as a Class II medical device ensures it meets hematology-specific standards for platelet function testing, providing assurance of its reliability for clinical and research use.
Does the software require any special handling or storage conditions?
Since the Aggro/Link vW Cofactor Software is a digital solution, it does not require physical storage conditions like temperature or humidity control. However, it must be installed on compatible hardware within a clinical or research setting, and the system should follow standard IT protocols for software maintenance, updates, and data security to ensure accurate and reliable operation.
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: AGGRO/LINK VW COFACTOR SOFTWARE (K940792) — FDA 510 (k) | Innolitics, AGGRO/LINK VW COFACTOR SOFTWARE 510(k) K940792 - FDA.report, Aggro/Link Vw Cofactor Software - Beudamed, PDF K940792 - Aggro/Link Vw Cofactor Software, CHRONO-LOG vW CoFactor Software GUDID Device - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K940792 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Chrono-Log Corp
- FDA Applicant
- Chrono-Log Corp.
Sources (1)
- FDA 510(k) K940792 24 fields · synced Sep 19, 2026