Emit Cad Quinidine Assay
by Syva Co. 510(k)
Active
510(k) K832096
Overview
The Emit Cad Quinidine Assay is an enzyme immunoassay used for the quantitative determination of quinidine in human serum or plasma. This diagnostic tool functions as a clinical toxicology device to measure drug concentrations.
This device is regulated as a Class II medical device under regulation number 862.3320. It received FDA 510(k) clearance under the traditional submission process.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK832096 | Date8 Aug 1983 | 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- Withdrawn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
- Full name
- Emit Cad Quinidine Assay for Use W/
- 510(k) Number
- FDA Product Code
- LBZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3320
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Syva Co.
Questions
What is the primary clinical use of the Emit Cad Quinidine Assay?
This device is a clinical toxicology tool used for the quantitative determination of quinidine concentrations in human serum or plasma samples.
How is this assay regulated?
The Emit Cad Quinidine Assay is regulated as a Class II medical device under regulation number 862.3320 and received FDA 510(k) clearance through the traditional submission process.
What technology does this device use to measure drug concentrations?
The device utilizes an enzyme immunoassay method to provide quantitative measurements of quinidine, allowing clinicians to assess drug levels in a patient's blood.