Cleared Traditional

K854245 - SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UV

K854245 is an FDA 510(k) clearance for SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UV, manufactured by Sigma Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code KQN cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K854245 · Sigma Diagnostics, Inc. · Chemistry device
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Jan 1986
Decision
93d
Days
Class 2
Risk

K854245 is an FDA 510(k) clearance for the SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UV. Classified as Radioassay, Angiotensin Converting Enzyme (product code KQN), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on January 22, 1986 after a review of 93 days - within the typical 510(k) review window.

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: 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 Sigma Diagnostics, Inc. devices

FDA 510(k) Submission Details - K854245

510(k) Number K854245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1985
Decision Date January 22, 1986
Days to Decision 93 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 88d · This submission: 93d
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 K854245.
THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT
K041657 · Thermo Electron Corporation · Aug 2004
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
ACE ACTIVITY MICROVIAL TEST SET
K821011 · Ventrex Laboratories, Inc. · May 1982
ANGIOTENSIN CONVERTING ENZYME ASSAY SYS
K791712 · Ventrex Laboratories, Inc. · Sep 1979