Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1100](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1100) → CIS — Hydrazone Colorimetry, Ast/Sgot

# CIS · Hydrazone Colorimetry, Ast/Sgot

_Clinical Chemistry · 21 CFR 862.1100 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIS

## Overview

- **Product Code:** CIS
- **Device Name:** Hydrazone Colorimetry, Ast/Sgot
- **Regulation:** [21 CFR 862.1100](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1100)
- **Device Class:** 2
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## 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](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIS/K032027.md) | CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST) | Cholestech Corp. | Sep 5, 2003 | SESE |
| [K896238](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIS/K896238.md) | COBAS READY AST REAGENT | Roche Diagnostic Systems, Inc. | Feb 16, 1990 | SESE |
| [K854187](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIS/K854187.md) | IN-VITRO TEST DETERMINATION OF SGOT (AST) | Clinical Data, Inc. | Nov 25, 1985 | SESE |
| [K812872](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIS/K812872.md) | OPTIONAL TOTAL CA-MODULE FOR IL 504/508 | Instrumentation Laboratory CO | Oct 26, 1981 | SESE |
| [K792410](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIS/K792410.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIS](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIS)

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