Cleared Traditional

K832468 - T4-RIA SINGLE REAGENT

K832468 is an FDA 510(k) clearance for T4-RIA SINGLE REAGENT, manufactured by Fairlake Laboratories. The device is a Class 2 Chemistry device with product code CDX cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K832468 · Fairlake Laboratories · Chemistry device
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Sep 1983
Decision
49d
Days
Class 2
Risk

K832468 is an FDA 510(k) clearance for the T4-RIA SINGLE REAGENT. Classified as Radioimmunoassay, Total Thyroxine (product code CDX), Class II - Special Controls.

Submitted by Fairlake Laboratories (Mchenry, US). The FDA issued a Cleared decision on September 12, 1983 after a review of 49 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.

View all Fairlake Laboratories devices

FDA 510(k) Submission Details - K832468

510(k) Number K832468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1983
Decision Date September 12, 1983
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 88d · This submission: 49d
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 94
Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K832468.
MMS T4 RIA KIT
K861320 · Micromedic Systems · Apr 1986
STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY
K860421 · American Dade · Feb 1986
T4 RIA
K833850 · Syncor Intl. Corp. · Jan 1984
MAGIC T4 125I RADIOIMMUNOASSAY
K831533 · Corning Medical & Scientific · Jun 1983
COAT-A-COUNT NEONATAL T4 KIT RIA KIT
K831107 · Diagnostic Products Corp. · May 1983
MONOCLONAL ANTIBODY T4 RADIO-KIT
K823265 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1982