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) → CIQ — Diazo, Ast/Sgot

# CIQ · Diazo, 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/CIQ

## Overview

- **Product Code:** CIQ
- **Device Name:** Diazo, 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 (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K881173](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIQ/K881173.md) | ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD) | Tech-Co, Inc. | Jun 7, 1988 | SESE |
| [K860216](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIQ/K860216.md) | SGOT (AST) REAGENT SET | Sterling Diagnostics, Inc. | Apr 3, 1986 | SESE |
| [K855189](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIQ/K855189.md) | GLUTAMIC OXALOACETIC TRANSAMINASE REAGENT SET | Technostics Intl. | Jan 14, 1986 | SESE |
| [K844322](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIQ/K844322.md) | SGOT REAGENT SET | Livonia Diagnostics, Inc. | Nov 27, 1984 | SESE |
| [K841065](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIQ/K841065.md) | SGOT REAGENT SET | Medical Specialties, Inc. | May 1, 1984 | SESE |
| [K821209](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIQ/K821209.md) | SGOT REAGENT SET | Omega Medical Electronics | Jul 14, 1982 | SESE |
| [K820466](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIQ/K820466.md) | SGOT REAGENT SET | Anco Medical Reagents & Assoc. | Mar 11, 1982 | SESE |

## Top Applicants

- Anco Medical Reagents & Assoc. — 1 clearance
- Livonia Diagnostics, Inc. — 1 clearance
- Medical Specialties, Inc. — 1 clearance
- Omega Medical Electronics — 1 clearance
- Sterling Diagnostics, Inc. — 1 clearance

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

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