Reagent Got, Enzyme
by Icn Pharmaceuticals, Inc. 510(k)
Active
510(k) K770318
Overview
This device is a reagent for NADH oxidation/NAD reduction assays, classified under Clinical Chemistry. It is designed to measure enzyme activity, specifically for AST/SGOT (aspartate aminotransferase/serum glutamic oxaloacetic transaminase) levels in biological samples, aiding in the diagnosis of liver function and metabolic disorders.
The reagent is supplied as a single-use diagnostic tool, intended for use in clinical chemistry laboratories. It is not sterile and requires proper handling and storage as specified by the manufacturer. The device has received FDA 510(k) clearance under the classification of Class II (CIT product code) and is regulated under 21 CFR 862.1100. No MRI safety information is provided.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK770318 | Date5 Apr 1977 | 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- Withdrawn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 Icn Pharmaceuticals, Inc.
Questions
What clinical applications is this reagent primarily used for in a laboratory setting?
This reagent is designed for measuring enzyme activity, specifically aspartate aminotransferase (AST/SGOT) levels in biological samples. It aids in diagnosing liver function and identifying metabolic disorders by providing quantitative results in clinical chemistry laboratories.
Is this reagent intended for single-use or repeated use, and what does that mean for handling?
The reagent is explicitly labeled as a single-use diagnostic tool, meaning each vial is intended for one test only. This requires careful handling to avoid contamination and ensure accurate results, as reuse could compromise sterility and reliability.
What storage conditions should be followed for this reagent, and why are they important?
While the exact storage conditions are not detailed in the data, the manufacturer’s instructions must be followed as this reagent is not sterile. Proper storage prevents degradation, ensures accuracy in AST/SGOT measurements, and maintains the reagent’s effectiveness for its intended clinical chemistry applications.
How was this device’s regulatory pathway determined, and what does that mean for its use?
The device received FDA 510(k) clearance under the classification of Class II (CIT product code) with a decision of *Substantially Equivalent* to a predicate device. This means it underwent a traditional review process by the FDA’s Clinical Chemistry (CH) advisory committee and is regulated under 21 CFR 862.1100, ensuring compliance with safety and performance standards for in vitro diagnostics.