Cleared Traditional

K943099 - URINARY CATECHOLAMINE KIT

K943099 is an FDA 510(k) clearance for URINARY CATECHOLAMINE KIT, manufactured by Bioanalytical Systems, Inc.. The device is a Class 1 Chemistry device with product code CHQ cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K943099 · Bioanalytical Systems, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 1994
Decision
100d
Days
Class 1
Risk

K943099 is an FDA 510(k) clearance for the URINARY CATECHOLAMINE KIT. Classified as Chromatographic/fluorometric Method, Catecholamines (product code CHQ), Class I - General Controls.

Submitted by Bioanalytical Systems, Inc. (West Lafayette, US). The FDA issued a Cleared decision on October 7, 1994 after a review of 100 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K943099

510(k) Number K943099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1994
Decision Date October 07, 1994
Days to Decision 100 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 88d · This submission: 100d
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

All 9
Devices cleared under the same product code (CHQ) and FDA review panel - the closest regulatory comparables to K943099.
PLASMA CATECHOLAMINE KIT
K972167 · Bioanalytical Systems, Inc. · Aug 1997
MODEL 5500 CEAS
K963938 · Esa, Inc. · Dec 1996
URINARY METANEPHRINE KIT
K952919 · Bioanalytical Systems, Inc. · Sep 1995
MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM
K931148 · Esa, Inc. · Jun 1993
PLASMA CATECHOLAMINES BY HPLC
K894966 · Bio-Rad · Oct 1989
URINARY FREE CATECHOLAMINES & METANEPHRINES (HPLC)
K873371 · Bio-Rad · Jan 1988
K943099 · URINARY CATECHOLAMINE KIT
Download PDF FDA Summary Bioanalytical Systems…