Cleared Traditional

K951685 - AURAFLEX TESTOSTERONE CALIBRATOR PACK

K951685 is an FDA 510(k) clearance for AURAFLEX TESTOSTERONE CALIBRATOR PACK, manufactured by Organon Teknika Corp.. The device is a Class 1 Chemistry device with product code CDZ cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K951685 · Organon Teknika Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1995
Decision
218d
Days
Class 1
Risk

K951685 is an FDA 510(k) clearance for the AURAFLEX TESTOSTERONE CALIBRATOR PACK. Classified as Radioimmunoassay, Testosterones And Dihydrotestosterone (product code CDZ), Class I - General Controls.

Submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on November 14, 1995 after a review of 218 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1680 - 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 - K951685

510(k) Number K951685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1995
Decision Date November 14, 1995
Days to Decision 218 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
130d slower than avg
Panel avg: 88d · This submission: 218d
Pathway characteristics
Predicate-based equivalence.

CDZ Device Classification - Class 1, General Controls

Product Code CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1680
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 - CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone

All 56
Devices cleared under the same product code (CDZ) and FDA review panel - the closest regulatory comparables to K951685.
TESTOSTERONEE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)
K963080 · Bayer Corp. · Sep 1996
IMMULITE TOTAL TESTOSTERONE
K955870 · Diagnostic Products Corp. · Feb 1996
IMMULITE SHBG (MODIFICATION)
K955440 · Diagnostic Products Corp. · Dec 1995
ACTIVE FREE TESTOSTERONE RIA
K952281 · Diagnostic Systems Laboratories, Inc. · Jul 1995
IMMULITE SHBG
K941797 · Diagnostic Products Corp. · Oct 1994
CIBA CORNING ACS TESTOSTERONE IMMUNOASSAY
K934562 · Ciba Corning Diagnostics Corp. · Dec 1993