Cleared Traditional

K854876 - ALDOSTERONE DIRECT RIA KIT

K854876 is an FDA 510(k) clearance for ALDOSTERONE DIRECT RIA KIT, manufactured by Biotecx Laboratories, Inc.. The device is a Class 2 Chemistry device with product code KQN cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K854876 · Biotecx Laboratories, Inc. · Chemistry device
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Mar 1986
Decision
101d
Days
Class 2
Risk

K854876 is an FDA 510(k) clearance for the ALDOSTERONE DIRECT RIA KIT. Classified as Radioassay, Angiotensin Converting Enzyme (product code KQN), Class II - Special Controls.

Submitted by Biotecx Laboratories, Inc. (Friendswood, US). The FDA issued a Cleared decision on March 17, 1986 after a review of 101 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 Biotecx Laboratories, Inc. devices

FDA 510(k) Submission Details - K854876

510(k) Number K854876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1985
Decision Date March 17, 1986
Days to Decision 101 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 88d · This submission: 101d
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 K854876.
THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT
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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