CJJ · Diazo, Alt/Sgpt
Clinical Chemistry · 21 CFR 862.1030 · Class 1
Overview
| Product Code | CJJ |
|---|---|
| Device Name | Diazo, Alt/Sgpt |
| Regulation | 21 CFR 862.1030 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
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.
Cleared Devices (2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K943003 | CALCIUM QVET | Prisma Systems | Dec 9, 1994 | SESE |
| K895128 | BIOTRACK ALT TEST CARTRIDGE | Biotrack, Inc. | Oct 6, 1989 | SESE |
Top Applicants
- Prisma Systems — 1 clearance
- Biotrack, Inc. — 1 clearance
