Elvi 810 Clotscanner
by Volu Sol Medical Industries 510(k)
Active
510(k) K791587
Overview
The Elvi 810 Clotscanner is a Class II medical instrument designed for coagulation testing, specifically within the field of hematology. It functions as a diagnostic device to assess blood clotting properties, aiding in the evaluation of coagulation disorders or the effectiveness of anticoagulant therapy.
This device is intended for use in clinical laboratory settings and has received FDA 510(k) clearance under product code KQG, classified under regulation 864.5400. It is a reusable instrument, with no explicit sterility or MRI safety information provided in the regulatory data. The device is authorized for use in the United States and adheres to hematology-specific standards as reviewed by the Hematology (HE) advisory committee.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK791587 | Date17 Sep 1979 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KQG
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.5400
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Volu Sol Medical Industries
Questions
What clinical setting is the Elvi 810 Clotscanner intended for use in, and how does it support patient care?
The Elvi 810 Clotscanner is designed exclusively for clinical laboratory settings, where it aids in diagnosing coagulation disorders or monitoring the effectiveness of anticoagulant therapy. By assessing blood clotting properties, it helps clinicians evaluate patients with conditions like hemophilia, thrombophilia, or those on blood thinners, ensuring tailored treatment plans based on precise coagulation test results.
Is the Elvi 810 Clotscanner a single-use or reusable device, and what does that mean for maintenance?
The Elvi 810 Clotscanner is a reusable instrument, meaning it is built to be used repeatedly in a clinical lab after proper cleaning and maintenance. This design reduces waste and cost over time but requires adherence to manufacturer guidelines for disinfection and upkeep to ensure accurate and reliable coagulation testing across multiple patient samples.
What regulatory pathway did the Elvi 810 Clotscanner follow to gain market authorization in the U.S., and which advisory committee reviewed it?
The Elvi 810 Clotscanner received FDA clearance through a Traditional 510(k) process, classified under product code KQG and regulation 864.5400. Its review was conducted by the Hematology (HE) Advisory Committee, which evaluates coagulation instruments to ensure they meet safety and performance standards for diagnosing blood clotting disorders.
Are there any specific storage requirements or considerations for the Elvi 810 Clotscanner mentioned in the regulatory data?
The provided regulatory data does not explicitly detail storage requirements for the Elvi 810 Clotscanner. However, as a reusable medical device used in laboratory settings, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its functionality and accuracy for coagulation testing.