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 862.1360](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1360) → NAO — Test, Carbohydrate Deficient Transferrin

# NAO · Test, Carbohydrate Deficient Transferrin

_Clinical Chemistry · 21 CFR 862.1360 · Class 1_

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

## Overview

- **Product Code:** NAO
- **Device Name:** Test, Carbohydrate Deficient Transferrin
- **Regulation:** [21 CFR 862.1360](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1360)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

A gamma-glutamyl transpeptidase and isoenzymes test system is a device intended to measure the activity of the enzyme gamma-glutamyl transpeptidase (GGTP) in plasma and serum. Gamma-glutamyl transpeptidase and isoenzymes measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors.

## 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 (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K060677](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NAO/K060677.md) | N LATEX CDT | Dade Behring, Inc. | Aug 25, 2006 | SESE |
| [K001943](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NAO/K001943.md) | CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY | Sangui Biotech, Inc. | Aug 23, 2000 | SESE |
| [K992502](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/NAO/K992502.md) | AXIS %CDT TURBIDIMETRIC IMMUNOASSAY | Axis | Dec 21, 1999 | SESE |

## Top Applicants

- Axis — 1 clearance
- Dade Behring, Inc. — 1 clearance
- Sangui Biotech, Inc. — 1 clearance

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

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