CKD · Hydrazone Colorimetry, Alt/Sgpt
Clinical Chemistry · 21 CFR 862.1030 · Class 1
Overview
| Product Code | CKD |
|---|---|
| Device Name | Hydrazone Colorimetry, 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.
Recent Cleared Devices (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K991834 | CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772 | Cholestech Corp. | Sep 9, 1999 | SESE |
| K941192 | ORTHO ALT MICROWELL TEST SYSTEM | Ortho Diagnostic Systems, Inc. | May 16, 1995 | SESE |
| K896237 | COBAS READY ALT REAGENT | Roche Diagnostic Systems, Inc. | Feb 16, 1990 | SESE |
| K884784 | VIRGO(R) MICROWELL ALT ASSAY | Electro-Nucleonics, Inc. | Dec 29, 1988 | SESE |
| K883387 | ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD) | Tech-Co, Inc. | Oct 13, 1988 | SESE |
| K864082 | REFLOTRON(R) ALT (GPT) | Boehringer Mannheim Corp. | Dec 4, 1986 | SESE |
| K860485 | SGPT (ALT) REAGENT SET (COLORIMETRIC) | Sterling Diagnostics, Inc. | Apr 3, 1986 | SESE |
| K844283 | SGPT REAGENT SET | Livonia Diagnostics, Inc. | Nov 27, 1984 | SESE |
| K841059 | SGPT REAGENT SET | Medical Specialties, Inc. | May 1, 1984 | SESE |
| K821207 | SGPT REAGENT SET | Omega Medical Electronics | Jul 14, 1982 | SESE |
| K820491 | SGPT REAGENT SET | Anco Medical Reagents & Assoc. | Mar 11, 1982 | SESE |
Top Applicants
- Anco Medical Reagents & Assoc. — 1 clearance
- Boehringer Mannheim Corp. — 1 clearance
- Cholestech Corp. — 1 clearance
- Electro-Nucleonics, Inc. — 1 clearance
- Livonia Diagnostics, Inc. — 1 clearance
