Cleared Traditional

K944697 - AURA FLEX FT4 200 TEST PACK

K944697 is an FDA 510(k) clearance for AURA FLEX FT4 200 TEST PACK, manufactured by Organon Teknika Corp.. The device is a Class 2 Chemistry device with product code CEC cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K944697 · Organon Teknika Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
152d
Days
Class 2
Risk

K944697 is an FDA 510(k) clearance for the AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK. Classified as Radioimmunoassay, Free Thyroxine (product code CEC), Class II - Special Controls.

Submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on February 22, 1995 after a review of 152 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1695 - 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 - K944697

510(k) Number K944697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1994
Decision Date February 22, 1995
Days to Decision 152 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
64d slower than avg
Panel avg: 88d · This submission: 152d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CEC Device Classification - Class 2, Special Controls

Product Code CEC Radioimmunoassay, Free Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1695
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 - CEC Radioimmunoassay, Free Thyroxine

All 66
Devices cleared under the same product code (CEC) and FDA review panel - the closest regulatory comparables to K944697.
ACA PLUS FREE THYROXINE(FT4) METHOD
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K942376 · Roche Diagnostic Systems, Inc. · Apr 1995
OPUS FT4 TEST SYSTEM
K940507 · Pb Diagnostic Systems, Inc. · Jul 1994
AXSYM FREE THYROXINE ( FREE T4 )
K934544 · Abbott Laboratories · Jun 1994
CIBA CORNING ACS FT3 IMMUNOASSAY
K940482 · Ciba Corning Diagnostics Corp. · Apr 1994