Emds Aspartate Aminotransferase Item Number 65405
by Diagnostic Systems 510(k)
Active
510(k) K893692
Overview
The EmDS Aspartate Aminotransferase Item Number 65405 is an in-vitro diagnostic device used in clinical chemistry to measure aspartate aminotransferase activity in serum. It utilizes a coupled enzymatic reaction monitored by NADH oxidation or NAD reduction spectrophotometrically.
The device is supplied with a product code of CIT and is classified as a Class 2 device. It has been cleared by the FDA with a 510(k) number of K893692 and is regulated under regulation number 862.1100. The device is intended for use in clinical chemistry settings.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK893692 | Date21 Aug 1989 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- CIT
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1100
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Diagnostic Systems
Questions
What is the EMDS Aspartate Aminotransferase Item 65405 used for?
This device is an in-vitro diagnostic tool used in clinical chemistry to measure aspartate aminotransferase (AST) activity in serum. It is intended for use in clinical chemistry settings to support diagnostic evaluation.
How does the EMDS Aspartate Aminotransferase Item 65405 work?
It utilizes a coupled enzymatic reaction where aspartate aminotransferase activity is measured by monitoring either the oxidation of NADH or the reduction of NAD via spectrophotometric detection. This method allows for quantitative analysis of AST levels in serum samples.
What is the regulatory classification of this device?
The device is classified as a Class 2 in-vitro diagnostic device under regulation number 862.1100. It has been cleared through the FDA 510(k) pathway with premarket notification number K893692, indicating it is substantially equivalent to a legally marketed predicate device.
Who is the manufacturer of this device?
The manufacturer is Diagnostic Systems, based at 480 Democrat Rd., Gibbstown, NJ 08027. The device is supplied under the product code CIT and is intended for use in clinical chemistry laboratories.