# K032199: Esa Plasma Free Metanephrine Analysis Kit

- Pathway: 510(k) (Traditional)
- Applicant: Esa, Inc.
- Decided: Jan 30, 2004 after 196 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) Model 5500 CEAS/Urinary Metanephrine and Norepinephrine: named in the summary without a submission number

## Indications for use
For In Vitro Diagnostic Use Only The ESA Plasma Free Metanephrine Analysis Kit is intended for use in clinical laboratories that hold a CLIA certificate to perform tests of high complexity to measure endogenous free levels of the metanephrines (normetanephrine and metanephrine) in plasma using high performance liquid chromatography with electrochemical detection. The analysis of these analytes is used in the differential diagnosis of adult male and female patients with pheochromocytoma.

Source page: https://510kreport.com/device/K032199
Methodology: https://510kreport.com/methodology