510(k) · Cleared

Cleared

Esa Plasma Free Metanephrine Analysis Kit

K032199510(k) TraditionalCleared Jan 30, 2004196-day reviewClass I21 CFR 862.1165

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Esa, Inc. · CHQ Chromatographic/Fluorometric Method, Catecholamines

Cleared on Jan 30, 2004 after a 196-day review. The FDA summary names its predicate without a number.

Decided: Jan 30, 2004
Review: 196 days
Class: Class I
Product code: CHQ
Recalls: None
Predicates: 0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K032199Source: FDA 510(k) database · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in CHQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	—	Model 5500 CEAS/Urinary Metanephrine and Norepinephrine Named without a submission number			—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All CHQ devices

CHQ Chromatographic/Fluorometric Method, Catecholamines: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CHQ

FDA has decided no CHQ device since 2007.

Median 510(k) review, days · CHQ

Too few CHQ 510(k)s in any year since 2007 to give a median.

Recalls per year · CHQ

No recall names CHQ since 2007.

Adverse event reports per year · CHQ

No MAUDE report names CHQ since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032199 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032199: Esa Plasma Free Metanephrine Analysis Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032199

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Page last updated Nov 3, 2026