Cleared Traditional

K860421 - STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY

K860421 is an FDA 510(k) clearance for STRAT TOTAL THYROXINE FLUOROMET ENZYME ..., manufactured by American Dade. The device is a Class 2 Chemistry device with product code CDX cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K860421 · American Dade · Chemistry device
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Feb 1986
Decision
7d
Days
Class 2
Risk

K860421 is an FDA 510(k) clearance for the STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY. Classified as Radioimmunoassay, Total Thyroxine (product code CDX), Class II - Special Controls.

Submitted by American Dade (Santa Ana, US). The FDA issued a Cleared decision on February 11, 1986 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1700 - 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.

FDA 510(k) Submission Details - K860421

510(k) Number K860421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1986
Decision Date February 11, 1986
Days to Decision 7 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
82d faster than avg
Panel avg: 89d · This submission: 7d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDX Device Classification - Class 2, Special Controls

Product Code CDX Radioimmunoassay, Total Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1700
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 - CDX Radioimmunoassay, Total Thyroxine

All 119
Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K860421.
T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT
K870573 · Cambridge Medical Technology · Apr 1987
IQ T4 IMMUNOASSAY
K864560 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1986
MMS T4 RIA KIT
K861320 · Micromedic Systems · Apr 1986
T-4 RIASSAY
K854798 · Ria Diagnostics · Jan 1986
PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT
K854324 · Pantex, Div. Bio-Analysis, Inc. · Dec 1985
IMMPULSE T4 ASSAY REAGENTS
K840852 · Paragon Diagnostics, Inc. · Apr 1984
K860421 · STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY
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