Emit Gentamicin Assay
by Syva Co. 510(k)
Active
510(k) K873854
Overview
The Emit Gentamicin Assay is an enzyme immunoassay used for the quantitative determination of gentamicin in human serum or plasma. It functions as an in vitro diagnostic device to measure the concentration of this specific antibiotic.
This device is regulated as a Class II medical device under regulation number 862.3450. It has received FDA 510(k) clearance, identified by submission number K873854.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK873854 | Date28 Oct 1987 | 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- Withdrawn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
- LCD
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3450
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Syva Co.
Questions
What is the primary function of the Emit Gentamicin Assay?
This device is an enzyme immunoassay used for the quantitative determination of the antibiotic gentamicin. It is intended for use as an in vitro diagnostic tool to measure the concentration of this specific drug within human serum or plasma.
What is the regulatory status of this assay?
The Emit Gentamicin Assay is classified as a Class II medical device under regulation number 862.3450. It has received FDA 510(k) clearance, which is documented under submission number K873854.
In which clinical specialty is this device categorized?
The device is categorized under the Clinical Toxicology specialty. This classification reflects its use in measuring drug concentrations, which is a standard procedure within toxicological and therapeutic drug monitoring environments.