# K972167: Plasma Catecholamine Kit

- Pathway: 510(k) (Traditional)
- Applicant: Bioanalytical Systems, Inc.
- Decided: Aug 4, 1997 after 56 days
- Product code: CHQ (Chromatographic/Fluorometric Method, Catecholamines)
- Device class: 1
- Regulation: 21 CFR 862.1165
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Bio-Rad Plasma Catecholamine by HPLC Kit: named in the summary without a submission number

## Indications for use
Catecholamine test system is a device intended to determine whether a group of similar compounds epinephrine and norepinephrine are present in 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.)

Source page: https://510kreport.com/device/K972167
Methodology: https://510kreport.com/methodology