Plus Chem S.C.E. Reagent
by Smithkline Diagnostics, Inc. 510(k)
Active
510(k) K791080
Overview
The Plus Chem S.C.E. Reagent is a diagnostic reagent used for clinical chemistry testing, specifically for measuring NADH oxidation/NAD reduction and AST/SGOT levels. Classified under the nomenclature for biochemical reagents, it facilitates enzymatic assays to evaluate liver function and metabolic processes in patient samples.
Supplied as a single-use reagent, this device is intended for use in clinical chemistry laboratories. It requires no sterilization beyond standard reagent preparation protocols and is regulated under FDA 510(k) clearance (K791080) as a Class II device under regulation number 862.1100. The reagent is packaged for laboratory use and adheres to clinical chemistry standards without MRI safety considerations.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK791080 | Date24 Jul 1979 | 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- Withdrawn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 Smithkline Diagnostics, Inc.
Questions
What is the Plus Chem S.C.E. Reagent used for in clinical settings?
The Plus Chem S.C.E. Reagent is designed for enzymatic assays in clinical chemistry laboratories to measure NADH oxidation/NAD reduction and AST (aspartate aminotransferase, also known as SGOT) levels. These measurements help evaluate liver function and metabolic processes in patient samples, providing critical diagnostic insights for clinicians.
How is the Plus Chem S.C.E. Reagent supplied and intended for use?
This reagent is supplied as a single-use product, packaged specifically for laboratory use. It is intended exclusively for in vitro diagnostic testing and does not require additional sterilization beyond standard reagent preparation protocols. Each unit is pre-portioned for one-time use to ensure accuracy and consistency in clinical chemistry assays.
Is the Plus Chem S.C.E. Reagent sterile, and if not, how should it be handled?
The reagent is not sterile as it is not designed for sterile applications. It adheres to standard reagent preparation protocols, meaning it should be handled in a clean laboratory environment to prevent contamination. Follow manufacturer guidelines for proper storage and preparation to maintain integrity and reliability in test results.
What regulatory clearance does the Plus Chem S.C.E. Reagent hold, and how does this affect its use?
The Plus Chem S.C.E. Reagent holds FDA 510(k) clearance under the classification of a Class II device (regulation number 862.1100). This clearance indicates it has been determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets established safety and performance standards for clinical chemistry reagents. Clinicians and laboratories may rely on this clearance as part of their due diligence when incorporating the reagent into their workflow.
Are there any special storage requirements for the Plus Chem S.C.E. Reagent?
While specific storage instructions are not detailed in the provided data, clinical chemistry reagents like this typically require protection from extreme temperatures, light exposure, and contamination. Store the reagent in a cool, dry place, away from direct sunlight, and follow the manufacturer’s guidelines for shelf life and handling to ensure optimal performance and accuracy in AST/SGOT measurements.