Cleared Traditional

K905214 - IMMULITE (TM) TOTAL T3

K905214 is an FDA 510(k) clearance for IMMULITE (TM) TOTAL T3, manufactured by Cirrus Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code CDP cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K905214 · Cirrus Diagnostics, Inc. · Chemistry device
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Feb 1991
Decision
73d
Days
Class 2
Risk

K905214 is an FDA 510(k) clearance for the IMMULITE (TM) TOTAL T3. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Cirrus Diagnostics, Inc. (Chester, US). The FDA issued a Cleared decision on February 1, 1991 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1710 - 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 Cirrus Diagnostics, Inc. devices

FDA 510(k) Submission Details - K905214

510(k) Number K905214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1990
Decision Date February 01, 1991
Days to Decision 73 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 88d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDP Device Classification - Class 2, Special Controls

Product Code CDP Radioimmunoassay, Total Triiodothyronine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1710
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 - CDP Radioimmunoassay, Total Triiodothyronine

All 119
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K905214.
DOCUMENT CK ISOENZYMES CONTROL
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K905410 · Pb Diagnostic Systems, Inc. · Feb 1991
IMX FREE TRIIODOTHYRONINE
K905261 · Abbott Laboratories · Jan 1991
FLAGEN TRIIODOTHYRONINE (T3) ASSAY
K905656 · Cyberfluor, Inc. · Jan 1991
MICROZYME T3 ENZYME IMMUNOASSAY KIT
K904820 · Immunotech Corp. · Dec 1990