Coulter AST (GOT) Reagent
by Coulter Electronics, Inc. 510(k)
Active
510(k) K897165
Overview
The Coulter AST (GOT) Reagent is a diagnostic reagent used for measuring aspartate aminotransferase (AST) and glutamic oxaloacetic transaminase (GOT) enzyme activity in clinical chemistry. It falls under the category of NADH oxidation/NAD reduction reagents, facilitating biochemical assays to evaluate liver function and detect tissue damage by quantifying enzyme levels in serum or plasma samples.
This reagent is supplied as a liquid for in vitro diagnostic use and is intended for single-use applications in clinical laboratories. It is classified as a Class II device under FDA regulations and has received a 510(k) clearance (K897165) for substantial equivalence. The product code assigned is CIT, and it is intended for use with automated clinical chemistry analyzers. Sterility and storage conditions are not specified in the regulatory data, but it is regulated under FDA regulation number 862.1100.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK897165 | Date23 Feb 1990 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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 Coulter Electronics, Inc.
Questions
What is the Coulter AST (GOT) Reagent used for?
The Coulter AST (GOT) Reagent is designed for measuring aspartate aminotransferase (AST) and glutamic oxaloacetic transaminase (GOT) enzyme activity in clinical chemistry. These enzymes are critical biomarkers for assessing liver function and identifying tissue damage, as their levels in serum or plasma can indicate conditions such as liver disease or injury. The reagent facilitates biochemical assays by enabling NADH oxidation/NAD reduction reactions, which are essential for quantifying enzyme activity in automated clinical chemistry analyzers.
How is the Coulter AST (GOT) Reagent supplied, and what is its intended use?
The Coulter AST (GOT) Reagent is supplied as a liquid formulation intended exclusively for in vitro diagnostic use. It is specifically designed for single-use applications in clinical laboratories, ensuring precision and consistency in AST/GOT measurements. The reagent is compatible with automated clinical chemistry analyzers, which streamline workflows and improve diagnostic accuracy by reducing manual intervention.
Is the sterility of the Coulter AST (GOT) Reagent specified?
The provided regulatory data does not explicitly state whether the Coulter AST (GOT) Reagent is sterile. For clinical use, it is critical to verify sterility requirements with the manufacturer or consult internal laboratory protocols, as unsterile reagents could introduce contamination risks. Always adhere to local laboratory standards and manufacturer guidelines to ensure patient safety and test validity.
Can the Coulter AST (GOT) Reagent be reused, or is it intended for single-use only?
The Coulter AST (GOT) Reagent is explicitly intended for single-use applications in clinical laboratories. Reusing diagnostic reagents can compromise accuracy, introduce cross-contamination, and pose risks to patient safety. Single-use formulations are standard in clinical chemistry to maintain consistency, reliability, and compliance with regulatory standards like those enforced by the FDA.
What storage conditions should be followed for the Coulter AST (GOT) Reagent?
While the regulatory data does not specify storage conditions for the Coulter AST (GOT) Reagent, proper storage is essential to preserve its integrity and performance. Typically, diagnostic reagents should be stored according to manufacturer instructions, which may include protecting from light, extreme temperatures, and contamination. For optimal results, consult the product documentation or contact Coulter Electronics for guidance on recommended storage practices.