Cleared Traditional

K851676 - TDX TOTAL T3

K851676 is an FDA 510(k) clearance for TDX TOTAL T3, manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code CDP cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K851676 · Abbott Laboratories · Chemistry device
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May 1985
Decision
27d
Days
Class 2
Risk

K851676 is an FDA 510(k) clearance for the TDX TOTAL T3. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 20, 1985 after a review of 27 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K851676

510(k) Number K851676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1985
Decision Date May 20, 1985
Days to Decision 27 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 88d · This submission: 27d
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 104
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K851676.
IMMUBEAD T3 ENZYME IMMUNOASSAY KIT
K872191 · Immunotech Corp. · Aug 1987
DELFIA(TM) TRIIODOTHYRONINE (T3) KIT
K864452 · Lkb Instruments, Inc. · Feb 1987
AMERLEX-M T3 RIA KIT FOR SERUM AND PLASMA
K860252 · Amersham Corp. · Feb 1986
AMERLEX-M FREE T-3 RIA
K842949 · Amersham Corp. · Sep 1984
CORNING IMMO PHASE FREE T3
K840222 · Corning Medical & Scientific · May 1984
FREE T3 SOLID PHASE RADIOIMMUNOASSAY
K840959 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1984