Cleared Traditional

STRATUS TOTAL TRIIODOTHYRONINE T3 FLUORO. ENZYME (K883479) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K883479 · Baxter Healthcare Corp · Chemistry device
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Oct 1988
Decision
70d
Days
Class 2
Risk

K883479 is an FDA 510(k) clearance for the STRATUS TOTAL TRIIODOTHYRONINE T3 FLUORO. ENZYME. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Miami, US). The FDA issued a Cleared decision on October 25, 1988 after a review of 70 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K883479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1988
Decision Date October 25, 1988
Days to Decision 70 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
18d faster than avg
Panel avg: 88d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 33
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K883479.
ABBOTT TDX TOTAL T3 PLUS
K894238 · Abbott Laboratories · Oct 1989
MILENIA(TM) TOTAL T4 (MKT41,5)
K895840 · Diagnostic Products Corp. · Oct 1989
STRATUS(R) TOTAL TRIIODOTHYRONINE (T3) F.E.I.
K894993 · Baxter Healthcare Corp · Oct 1989
ABBOTT IMX T3
K880087 · Abbott Laboratories · Apr 1988
TDX TOTAL T3
K851676 · Abbott Laboratories · May 1985
FREE T3 SOLID PHASE RADIOIMMUNOASSAY
K840959 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1984