21 CFR 862.1030 — Diazo, Alt/Sgpt
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1030
Identification
An alanine amino transferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CJJ | Diazo, Alt/Sgpt | 1 | 2 | |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 | 127 | |
| CKC | Vanillin Pyruvate, Alt/Sgpt | 1 | 2 | |
| CKD | Hydrazone Colorimetry, Alt/Sgpt | 1 | 11 |
