5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase
The 5-AMP-Phosphate Release Colorimetric 5'-Nucleotidase Test is a clinical chemistry device that measures 5'-nucleotidase enzyme activity in serum by detecting the release of 5-AMP phosphate through a colorimetric reaction, used to help differentiate hepatobiliary disease from bone disease in patients with elevated alkaline phosphatase levels. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification. The product code is CED, regulated under 21 CFR 862.1520, within the Clinical Chemistry medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- CED
- Device Class
- FDA class 1
- Regulation Number
- 862.1520
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K894288 | PHOSPHORUS TEST ITEM NUMBER 65416 | Aug 31, 1989 | Substantially Equivalent | Em Diagnostic Systems, Inc. |
| K840151 | EKTACHEM CLINICAL CHEM. SLIDES | Mar 22, 1984 | Substantially Equivalent | Eastman Kodak Company |
| K833710 | BTC URINE LH ASSAY | Jan 30, 1984 | Substantially Equivalent | Btc Diagnostics, Inc. |
| K820832 | PHOSPHORUS IL | Apr 15, 1982 | Substantially Equivalent | American Monitor Corp. |
| K812670 | SANDARE FAST 340 PHOSPHORUS PROCEDURE | Oct 02, 1981 | Substantially Equivalent | Sandare Chemical Co., Inc. |
| K811864 | SIGMA PROCEDURE 265-UV | Jul 31, 1981 | Substantially Equivalent | Sigma Chemical Co. |
| K811222 | INORGANIC PHOSPHORUS REAGENTS | May 21, 1981 | Substantially Equivalent | Connecticut Diagnostics, Ltd. |
| K802420 | CENTRIFICHEM INORGANIC PHOSPHORUS | Oct 31, 1980 | Substantially Equivalent | Union Carbide Corp. |
| K790662 | CENTRIFICHEM INORGANIC PHOSPHORUS | May 15, 1979 | Substantially Equivalent | Union Carbide Corp. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.