Cleared Traditional

K946199 - AURAFLEX ESTRADIOL

K946199 is an FDA 510(k) clearance for AURAFLEX ESTRADIOL, manufactured by Organon Teknika Corp.. The device is a Class 1 Chemistry device with product code CHP cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K946199 · Organon Teknika Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
104d
Days
Class 1
Risk

K946199 is an FDA 510(k) clearance for the AURAFLEX(R) ESTRADIOL. Classified as Radioimmunoassay, Estradiol (product code CHP), Class I - General Controls.

Submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on April 3, 1995 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1260 - 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 Organon Teknika Corp. devices

FDA 510(k) Submission Details - K946199

510(k) Number K946199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1994
Decision Date April 03, 1995
Days to Decision 104 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
16d slower than avg
Panel avg: 88d · This submission: 104d
Pathway characteristics
Predicate-based equivalence.

CHP Device Classification - Class 1, General Controls

Product Code CHP Radioimmunoassay, Estradiol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1260
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 - CHP Radioimmunoassay, Estradiol

All 33
Devices cleared under the same product code (CHP) and FDA review panel - the closest regulatory comparables to K946199.
CIBA CORNING ACS ESTRADIOL-6 ASSAY
K954697 · Ciba Corning Diagnostics Corp. · Dec 1995
ULTRA-SENSITIVE ESTRADIOL
K953605 · Diagnostic Systems Laboratories, Inc. · Oct 1995
ESTRADIOL ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC SYSTEM
K951360 · Bayer Corp. · May 1995
COAT-A-COUNT(R) ESTRADIOL-6
K943193 · Diagnostic Products Corp. · Feb 1995
CLINICAL ASSAYS GAMMACOAT [125] ESTRADIOL RADIOIMMUNOASSAY KIT
K941168 · Incstar Corp. · Sep 1994
IMMULITE ESTRADIOL
K932926 · Diagnostic Products Corp. · Jan 1994