Elvi Acid & Prostatic Phosphatase
by Volu Sol Medical Industries 510(k)
Active
510(k) K792405
Overview
Elvi Acid & Prostatic Phosphatase is a Class 2 Chemistry device used for measuring acid phosphatase levels, specifically tartrate-inhibited prostatic acid phosphatase. This device is designed for clinical laboratory testing to assist in the diagnosis and monitoring of certain medical conditions.
The device is manufactured by Volu Sol Medical Industries and is supplied as a single-use or reusable product depending on the specific configuration. It is regulated under 21 CFR 862.1020 and received FDA 510(k) clearance on December 7, 1979, with K number K792405. The device is intended for use in clinical chemistry laboratories and is not MRI compatible.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK792405 | Date7 Dec 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- Withdrawn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
- JFH
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1020
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Volu Sol Medical Industries
Questions
What is the primary clinical purpose of the Elvi Acid & Prostatic Phosphatase?
This device is intended for use in clinical chemistry laboratories to measure acid phosphatase levels, specifically focusing on tartrate-inhibited prostatic acid phosphatase, to assist in the diagnosis and monitoring of medical conditions.
Is the Elvi Acid & Prostatic Phosphatase compatible with MRI environments?
No, this device is not MRI compatible. It is designed specifically for use within clinical chemistry laboratory settings and should not be used in proximity to magnetic resonance imaging equipment.
How is the Elvi Acid & Prostatic Phosphatase supplied for laboratory use?
The device is supplied as either a single-use or reusable product, depending on the specific configuration selected for your laboratory requirements.
What is the regulatory status of this device?
The Elvi Acid & Prostatic Phosphatase is a Class 2 chemistry device regulated under 21 CFR 862.1020. It received FDA 510(k) clearance on December 7, 1979, under submission number K792405.