Cleared Traditional

AURAFLEX(R) ESTRADIOL (K946199) - FDA 510(k) Clearance

Class I Chemistry device.

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

Submission Details

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.

Device Classification

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 15
Devices cleared under the same product code (CHP) and FDA review panel - the closest regulatory comparables to K946199.
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K973743 · Beckman Instruments, Inc. · Oct 1997
ELECSYS ESTRADIOL ASSAY
K965109 · Boehringer Mannheim Corp. · Feb 1997
COAT-A-COUNT(R) ESTRADIOL-6
K943193 · Diagnostic Products Corp. · Feb 1995
IMMULITE ESTRADIOL
K932926 · Diagnostic Products Corp. · Jan 1994
COTUBE ESTRADIOL RADIOIMMUNOASSAY
K931740 · Bio-Rad · Aug 1993
IMX ESTRADIOL
K920047 · Abbott Laboratories · Feb 1992