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 862.1520](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1520) → CED — 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase

# CED · 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase

_Clinical Chemistry · 21 CFR 862.1520 · Class 1_

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

## Overview

- **Product Code:** CED
- **Device Name:** 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase
- **Regulation:** [21 CFR 862.1520](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1520)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

A 5′-nucleotidase test system is a device intended to measure the activity of the enzyme 5′-nucleotidase in serum and plasma. Measurements of 5′-nucleotidase are used in the diagnosis and treatment of liver diseases and in the differentiations between liver and bone diseases in the presence of elevated serum alkaline phosphatase activity.

## 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 (9 of 9)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K894288](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CED/K894288.md) | PHOSPHORUS TEST ITEM NUMBER  65416 | Em Diagnostic Systems, Inc. | Aug 31, 1989 | SESE |
| [K840151](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CED/K840151.md) | EKTACHEM CLINICAL CHEM. SLIDES | Eastman Kodak Company | Mar 22, 1984 | SESE |
| [K833710](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CED/K833710.md) | BTC URINE LH ASSAY | Btc Diagnostics, Inc. | Jan 30, 1984 | SESE |
| [K820832](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CED/K820832.md) | PHOSPHORUS IL | American Monitor Corp. | Apr 15, 1982 | SESE |
| [K812670](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CED/K812670.md) | SANDARE FAST 340 PHOSPHORUS PROCEDURE | Sandare Chemical Co., Inc. | Oct 2, 1981 | SESE |
| [K811864](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CED/K811864.md) | SIGMA PROCEDURE 265-UV | Sigma Chemical Co. | Jul 31, 1981 | SESE |
| [K811222](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CED/K811222.md) | INORGANIC PHOSPHORUS REAGENTS | Connecticut Diagnostics, Ltd. | May 21, 1981 | SESE |
| [K802420](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CED/K802420.md) | CENTRIFICHEM INORGANIC PHOSPHORUS | Union Carbide Corp. | Oct 31, 1980 | SESE |
| [K790662](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CED/K790662.md) | CENTRIFICHEM INORGANIC PHOSPHORUS | Union Carbide Corp. | May 15, 1979 | SESE |

## Top Applicants

- Union Carbide Corp. — 2 clearances
- American Monitor Corp. — 1 clearance
- Btc Diagnostics, Inc. — 1 clearance
- Connecticut Diagnostics, Ltd. — 1 clearance
- Eastman Kodak Company — 1 clearance

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

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