CED · 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase
Clinical Chemistry · 21 CFR 862.1520 · Class 1
Overview
| Product Code | CED |
|---|---|
| Device Name | 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase |
| Regulation | 21 CFR 862.1520 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
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 | PHOSPHORUS TEST ITEM NUMBER 65416 | Em Diagnostic Systems, Inc. | Aug 31, 1989 | SESE |
| K840151 | EKTACHEM CLINICAL CHEM. SLIDES | Eastman Kodak Company | Mar 22, 1984 | SESE |
| K833710 | BTC URINE LH ASSAY | Btc Diagnostics, Inc. | Jan 30, 1984 | SESE |
| K820832 | PHOSPHORUS IL | American Monitor Corp. | Apr 15, 1982 | SESE |
| K812670 | SANDARE FAST 340 PHOSPHORUS PROCEDURE | Sandare Chemical Co., Inc. | Oct 2, 1981 | SESE |
| K811864 | SIGMA PROCEDURE 265-UV | Sigma Chemical Co. | Jul 31, 1981 | SESE |
| K811222 | INORGANIC PHOSPHORUS REAGENTS | Connecticut Diagnostics, Ltd. | May 21, 1981 | SESE |
| K802420 | CENTRIFICHEM INORGANIC PHOSPHORUS | Union Carbide Corp. | Oct 31, 1980 | SESE |
| K790662 | 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
