Cleared Traditional

K032199 - ESA PLASMA FREE METANEPHRINE ANALYSIS KIT

K032199 is an FDA 510(k) clearance for ESA PLASMA FREE METANEPHRINE ANALYSIS KIT, manufactured by Esa, Inc.. The device is a Class 1 Chemistry device with product code CHQ cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K032199 · Esa, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2004
Decision
196d
Days
Class 1
Risk

K032199 is an FDA 510(k) clearance for the ESA PLASMA FREE METANEPHRINE ANALYSIS KIT. Classified as Chromatographic/fluorometric Method, Catecholamines (product code CHQ), Class I - General Controls.

Submitted by Esa, Inc. (Chelmsford, US). The FDA issued a Cleared decision on January 30, 2004 after a review of 196 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1165 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Esa, Inc. devices

FDA 510(k) Submission Details - K032199

510(k) Number K032199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2003
Decision Date January 30, 2004
Days to Decision 196 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 88d · This submission: 196d
Pathway characteristics
Predicate-based equivalence.

CHQ Device Classification - Class 1, General Controls

Product Code CHQ Chromatographic/fluorometric Method, Catecholamines
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1165
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CHQ Chromatographic/fluorometric Method, Catecholamines

Devices cleared under the same product code (CHQ) and FDA review panel - the closest regulatory comparables to K032199.
TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE)
K051969 · Ibl GmbH · Oct 2005
PLASMA CATECHOLAMINE KIT
K972167 · Bioanalytical Systems, Inc. · Aug 1997
MODEL 5500 CEAS
K963938 · Esa, Inc. · Dec 1996
PLASMA CATECHOLAMINES BY HPLC
K894966 · Bio-Rad · Oct 1989
URINARY FREE CATECHOLAMINES & METANEPHRINES (HPLC)
K873371 · Bio-Rad · Jan 1988