CHQ · Chromatographic/Fluorometric Method, Catecholamines
Clinical Chemistry · 21 CFR 862.1165 · Class 1
Overview
| Product Code | CHQ |
|---|---|
| Device Name | Chromatographic/Fluorometric Method, Catecholamines |
| Regulation | 21 CFR 862.1165 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A catecholamines (total) test system is a device intended to determine whether a group of similar compounds (epinephrine, norepinephrine, and dopamine) are present in urine and plasma. Catecholamine determinations are used in the diagnosis and treatment of adrenal medulla and hypertensive disorders, and for catecholamine-secreting tumors (pheochromo-cytoma, neuroblastoma, ganglioneuroma, and retinoblastoma).
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 (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K051969 | TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRENALIN/NORADRENALIN); NORADRENALIN RIA | Ibl GmbH | Oct 3, 2005 | SESE |
| K032199 | ESA PLASMA FREE METANEPHRINE ANALYSIS KIT | Esa, Inc. | Jan 30, 2004 | SESE |
| K972167 | PLASMA CATECHOLAMINE KIT | Bioanalytical Systems, Inc. | Aug 4, 1997 | SESE |
| K963938 | MODEL 5500 CEAS | Esa, Inc. | Dec 26, 1996 | SESE |
| K952919 | URINARY METANEPHRINE KIT | Bioanalytical Systems, Inc. | Sep 6, 1995 | SESE |
| K943099 | URINARY CATECHOLAMINE KIT | Bioanalytical Systems, Inc. | Oct 7, 1994 | SESE |
| K931148 | MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM | Esa, Inc. | Jun 9, 1993 | SESE |
| K894966 | PLASMA CATECHOLAMINES BY HPLC | Bio-Rad | Oct 25, 1989 | SESE |
| K873371 | URINARY FREE CATECHOLAMINES & METANEPHRINES (HPLC) | Bio-Rad | Jan 5, 1988 | SESE |
| K855214 | CAT-3 CATECHOLAMINE ASSAY KIT | Whale Scientific, Inc. | Mar 14, 1986 | SESE |
Top Applicants
- Bioanalytical Systems, Inc. — 3 clearances
- Esa, Inc. — 3 clearances
- Bio-Rad — 2 clearances
- Ibl GmbH — 1 clearance
- Whale Scientific, Inc. — 1 clearance
