Cleared Traditional

K831533 - MAGIC T4 125I RADIOIMMUNOASSAY

K831533 is an FDA 510(k) clearance for MAGIC T4 125I RADIOIMMUNOASSAY, manufactured by Corning Medical & Scientific. The device is a Class 2 Chemistry device with product code CDX cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K831533 · Corning Medical & Scientific · Chemistry device
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Jun 1983
Decision
48d
Days
Class 2
Risk

K831533 is an FDA 510(k) clearance for the MAGIC T4 125I RADIOIMMUNOASSAY. Classified as Radioimmunoassay, Total Thyroxine (product code CDX), Class II - Special Controls.

Submitted by Corning Medical & Scientific (Mchenry, US). The FDA issued a Cleared decision on June 30, 1983 after a review of 48 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 - K831533

510(k) Number K831533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1983
Decision Date June 30, 1983
Days to Decision 48 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
41d faster than avg
Panel avg: 89d · This submission: 48d
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 K831533.
T4 RIA
K833850 · Syncor Intl. Corp. · Jan 1984
RIACOAT T-4
K833745 · Immuno Assay Corp. · Jan 1984
T4-RIA SINGLE REAGENT
K832468 · Fairlake Laboratories · Sep 1983
COAT-A-COUNT NEONATAL T4 KIT RIA KIT
K831107 · Diagnostic Products Corp. · May 1983
PHASE THYROXINE RADIOIMMUNOASSAY KIT
K830642 · Medical & Scientific Designs, Inc. · Apr 1983
MONOCLONAL ANTIBODY T4 RADIO-KIT
K823265 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1982
K831533 · MAGIC T4 125I RADIOIMMUNOASSAY
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