Chromatographic/Fluorometric Method, Catecholamines
The Chromatographic/Fluorometric Method, Catecholamines test system (product code CHQ) is an in-vitro diagnostic device used in clinical chemistry to measure catecholamines such as epinephrine, norepinephrine, and dopamine in urine or plasma using a chromatographic separation combined with fluorometric detection, supporting the diagnosis of pheochromocytoma and neuroblastoma. It is classified as FDA Class 1, the lowest risk tier, subject to general controls only and not requiring premarket notification. It falls under regulation 21 CFR 862.1165 in the Clinical Chemistry medical specialty.
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Basic Information
- Product Code
- CHQ
- Device Class
- FDA class 1
- Regulation Number
- 862.1165
- 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 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K051969 | TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRENALIN/NORADRENALIN); NORADRENALIN RIA | Oct 03, 2005 | Substantially Equivalent | Ibl GmbH |
| K032199 | ESA PLASMA FREE METANEPHRINE ANALYSIS KIT | Jan 30, 2004 | Substantially Equivalent | Esa, Inc. |
| K972167 | PLASMA CATECHOLAMINE KIT | Aug 04, 1997 | Substantially Equivalent | Bioanalytical Systems, Inc. |
| K963938 | MODEL 5500 CEAS | Dec 26, 1996 | Substantially Equivalent | Esa, Inc. |
| K952919 | URINARY METANEPHRINE KIT | Sep 06, 1995 | Substantially Equivalent | Bioanalytical Systems, Inc. |
| K943099 | URINARY CATECHOLAMINE KIT | Oct 07, 1994 | Substantially Equivalent | Bioanalytical Systems, Inc. |
| K931148 | MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM | Jun 09, 1993 | Substantially Equivalent | Esa, Inc. |
| K894966 | PLASMA CATECHOLAMINES BY HPLC | Oct 25, 1989 | Substantially Equivalent | Bio-Rad |
| K873371 | URINARY FREE CATECHOLAMINES & METANEPHRINES (HPLC) | Jan 05, 1988 | Substantially Equivalent | Bio-Rad |
| K855214 | CAT-3 CATECHOLAMINE ASSAY KIT | Mar 14, 1986 | Substantially Equivalent | Whale Scientific, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.