Cleared Traditional

K041657 - THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT

K041657 is an FDA 510(k) clearance for THERMO ELECTRON ANGIOTENSIN CONVERTING ..., manufactured by Thermo Electron Corporation. The device is a Class 2 Chemistry device with product code KQN cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K041657 · Thermo Electron Corporation · Chemistry device
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Aug 2004
Decision
73d
Days
Class 2
Risk

K041657 is an FDA 510(k) clearance for the THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT. Classified as Radioassay, Angiotensin Converting Enzyme (product code KQN), Class II - Special Controls.

Submitted by Thermo Electron Corporation (Louisville, US). The FDA issued a Cleared decision on August 30, 2004 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1090 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Thermo Electron Corporation devices

FDA 510(k) Submission Details - K041657

510(k) Number K041657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2004
Decision Date August 30, 2004
Days to Decision 73 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 88d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KQN Device Classification - Class 2, Special Controls

Product Code KQN Radioassay, Angiotensin Converting Enzyme
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1090
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - KQN Radioassay, Angiotensin Converting Enzyme

Devices cleared under the same product code (KQN) and FDA review panel - the closest regulatory comparables to K041657.
ANGIOTENSIN CONVERTING ENZYME REA
K942497 · American Laboratory Products Co., Ltd. · Nov 1994
BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY
K913091 · American Laboratory Products Co., Ltd. · Aug 1991
SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UV
K854245 · Sigma Diagnostics, Inc. · Jan 1986
ACE ACTIVITY MICROVIAL TEST SET
K821011 · Ventrex Laboratories, Inc. · May 1982
ANGIOTENSIN CONVERTING ENZYME ASSAY SYS
K791712 · Ventrex Laboratories, Inc. · Sep 1979