KQN · Radioassay, Angiotensin Converting Enzyme
Clinical Chemistry · 21 CFR 862.1090 · Class 2
Overview
| Product Code | KQN |
|---|---|
| Device Name | Radioassay, Angiotensin Converting Enzyme |
| Regulation | 21 CFR 862.1090 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
Identification
An angiotensin converting enzyme (A.C.E.) test system is a device intended to measure the activity of angiotensin converting enzyme in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of diseases such as sarcoidosis, a disease characterized by the formation of nodules in the lungs, bones, and skin, and Gaucher's disease, a hereditary disorder affecting the spleen.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K041657 | THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT | Thermo Electron Corporation | Aug 30, 2004 | SESE |
| K942497 | ANGIOTENSIN CONVERTING ENZYME REA | American Laboratory Products Co., Ltd. | Nov 15, 1994 | SESE |
| K913091 | BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY | American Laboratory Products Co., Ltd. | Aug 26, 1991 | SESE |
| K854876 | ALDOSTERONE DIRECT RIA KIT | Biotecx Laboratories, Inc. | Mar 17, 1986 | SESE |
| K854245 | SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UV | Sigma Diagnostics, Inc. | Jan 22, 1986 | SESE |
| K833933 | ACE COLOR TEST | Hana Biologics, Inc. | Mar 23, 1984 | SESE |
| K821011 | ACE ACTIVITY MICROVIAL TEST SET | Ventrex Laboratories, Inc. | May 3, 1982 | SESE |
| K791712 | ANGIOTENSIN CONVERTING ENZYME ASSAY SYS | Ventrex Laboratories, Inc. | Sep 19, 1979 | SESE |
Top Applicants
- American Laboratory Products Co., Ltd. — 2 clearances
- Ventrex Laboratories, Inc. — 2 clearances
- Biotecx Laboratories, Inc. — 1 clearance
- Hana Biologics, Inc. — 1 clearance
- Sigma Diagnostics, Inc. — 1 clearance
