CIS · Hydrazone Colorimetry, Ast/Sgot
Clinical Chemistry · 21 CFR 862.1100 · Class 2
Overview
| Product Code | CIS |
|---|---|
| Device Name | Hydrazone Colorimetry, Ast/Sgot |
| Regulation | 21 CFR 862.1100 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
Identification
An aspartate amino transferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K032027 | CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST) | Cholestech Corp. | Sep 5, 2003 | SESE |
| K896238 | COBAS READY AST REAGENT | Roche Diagnostic Systems, Inc. | Feb 16, 1990 | SESE |
| K854187 | IN-VITRO TEST DETERMINATION OF SGOT (AST) | Clinical Data, Inc. | Nov 25, 1985 | SESE |
| K812872 | OPTIONAL TOTAL CA-MODULE FOR IL 504/508 | Instrumentation Laboratory CO | Oct 26, 1981 | SESE |
| K792410 | ELVI SGOT & SGPT TRANSAMINASE | Volu Sol Medical Industries | Dec 6, 1979 | SESE |
Top Applicants
- Cholestech Corp. — 1 clearance
- Clinical Data, Inc. — 1 clearance
- Instrumentation Laboratory CO — 1 clearance
- Roche Diagnostic Systems, Inc. — 1 clearance
- Volu Sol Medical Industries — 1 clearance
