NEO · System, Test, Osteocalcin
Clinical Chemistry · 21 CFR 862.1050 · Class 2
Overview
| Product Code | NEO |
|---|---|
| Device Name | System, Test, Osteocalcin |
| Regulation | 21 CFR 862.1050 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
Classification Rationale
Class II.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K051297 | ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCHECK | Roche Diagnostics Corp. | Sep 8, 2005 | SESE |
| K003609 | N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000 | Osteometer Biotech A/S | May 16, 2001 | SESE |
Top Applicants
- Osteometer Biotech A/S — 1 clearance
- Roche Diagnostics Corp. — 1 clearance
