Cleared Traditional

K930322 - FREE THYROXINE(F T4) METHOD/TECHNICON I...

K930322 is the FDA 510(k) clearance for FREE THYROXINE(F T4) METHOD/TECHNICON I... by Heraeus Kulzer, Inc.. It is a Class 2 Chemistry device (product code CEC) cleared through the Traditional 510(k) pathway after a 292-day FDA review.

K930322 · Heraeus Kulzer, Inc. · Chemistry device
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Nov 1993
Decision
292d
Days
Class 2
Risk

K930322 is an FDA 510(k) clearance for the FREE THYROXINE(F T4) METHOD/TECHNICON IMMUNO 1(R). Classified as Radioimmunoassay, Free Thyroxine (product code CEC), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (Tarrytown, US). The FDA issued a Cleared decision on November 10, 1993 after a review of 292 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 Heraeus Kulzer, Inc. devices

Submission Details

510(k) Number K930322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1993
Decision Date November 10, 1993
Days to Decision 292 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
204d slower than avg
Panel avg: 88d · This submission: 292d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K930322.
AXSYM FREE THYROXINE ( FREE T4 )
K934544 · Abbott Laboratories · Jun 1994
CIBA CORNING ACS FT3 IMMUNOASSAY
K940482 · Ciba Corning Diagnostics Corp. · Apr 1994
COBAS(R) CORE FT4 EIA
K932607 · Roche Diagnostic Systems, Inc. · Jan 1994
STRATUS FREE THYROXINE (FREE T4) FLUOROMETRIC
K932912 · Baxter Diagnostics, Inc. · Oct 1993
IMMULITE FREE T4
K931704 · Diagnostic Products Corp. · Aug 1993
RADIAS FREE T4 ENZYME IMMUNOASSAY
K931110 · Bio-Rad · May 1993