Cleared Traditional

K922284 - ELEGANCE FT4 ELISA

K922284 is an FDA 510(k) clearance for ELEGANCE FT4 ELISA, manufactured by Bioclone Australia Pty , Ltd.. The device is a Class 2 Chemistry device with product code CEC cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K922284 · Bioclone Australia Pty , Ltd. · Chemistry device
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Jul 1992
Decision
56d
Days
Class 2
Risk

K922284 is an FDA 510(k) clearance for the ELEGANCE FT4 ELISA. Classified as Radioimmunoassay, Free Thyroxine (product code CEC), Class II - Special Controls.

Submitted by Bioclone Australia Pty , Ltd. (Washington, US). The FDA issued a Cleared decision on July 10, 1992 after a review of 56 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bioclone Australia Pty , Ltd. devices

FDA 510(k) Submission Details - K922284

510(k) Number K922284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1992
Decision Date July 10, 1992
Days to Decision 56 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 88d · This submission: 56d
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 80
Devices cleared under the same product code (CEC) and FDA review panel - the closest regulatory comparables to K922284.
VIDAS FREE THYROXINE(FT4) ASSAY
K925177 · Biomerieux Vitek, Inc. · Nov 1992
VISTA FREE THYROXINE ASSAY
K923572 · Syva Co. · Nov 1992
KODAK AMERLITE MAB FT3 ASSAY
K922713 · Eastman Kodak Company · Oct 1992
AMERLITE MAB FT4 ASSAY
K920247 · Eastman Kodak Company · Mar 1992
SR1 FREE T4 ENZYME IMMUNOASSAY
K912937 · Serono-Baker Diagnostics, Inc. · Nov 1991
AFFINITY FREE T4 TEST SYSTEM
K912698 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1991