Cleared Traditional

K922945 - TECHNICON DAX SYSTEM THYROXINE (T4) METHOD

K922945 is an FDA 510(k) clearance for TECHNICON DAX SYSTEM THYROXINE (T4) METHOD, manufactured by Heraeus Kulzer, Inc.. The device is a Class 2 Chemistry device with product code CDX cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K922945 · Heraeus Kulzer, Inc. · Chemistry device
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Oct 1992
Decision
118d
Days
Class 2
Risk

K922945 is an FDA 510(k) clearance for the TECHNICON DAX SYSTEM THYROXINE (T4) METHOD. Classified as Radioimmunoassay, Total Thyroxine (product code CDX), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (Tarrytown, US). The FDA issued a Cleared decision on October 14, 1992 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1700 - 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 Heraeus Kulzer, Inc. devices

FDA 510(k) Submission Details - K922945

510(k) Number K922945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1992
Decision Date October 14, 1992
Days to Decision 118 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 88d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDX Device Classification - Class 2, Special Controls

Product Code CDX Radioimmunoassay, Total Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1700
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 - CDX Radioimmunoassay, Total Thyroxine

All 93
Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K922945.
STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO
K933426 · Baxter Diagnostics, Inc. · Aug 1993
ABBOTT IMX T4
K925110 · Abbott Laboratories · Jan 1993
ABBOTT TDX/TDXFLX TT4
K925109 · Abbott Laboratories · Jan 1993
THYROXINE (T4) COATED TUBE RIA
K921935 · Monobind · Jul 1992
T4 EIA BEAD ASSAY
K920766 · Tech-Co, Inc. · Apr 1992
CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT
K915235 · Incstar Corp. · Jan 1992