Cleared Traditional

K801105 - THYROXINE RADIOIMMUNOASSAY KIT

K801105 is the FDA 510(k) clearance for THYROXINE RADIOIMMUNOASSAY KIT by Calbiochem-Behring Corp.. It is a Class 2 Chemistry device (product code CDX) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K801105 · Calbiochem-Behring Corp. · Chemistry device
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Jun 1980
Decision
31d
Days
Class 2
Risk

K801105 is an FDA 510(k) clearance for the THYROXINE RADIOIMMUNOASSAY KIT. Classified as Radioimmunoassay, Total Thyroxine (product code CDX), Class II - Special Controls.

Submitted by Calbiochem-Behring Corp. (Mchenry, US). The FDA issued a Cleared decision on June 9, 1980 after a review of 31 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 Calbiochem-Behring Corp. devices

Submission Details

510(k) Number K801105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1980
Decision Date June 09, 1980
Days to Decision 31 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
57d faster than avg
Panel avg: 88d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 68
Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K801105.
COAT-A-COUNT T4 RIA KIT
K811315 · Diagnostic Products Corp. · May 1981
IMMU-TRACE T4 RIA PROCEDURE
K803046 · American Dade · Jan 1981
T4 RADIOIMMUNOASSAY KIT
K802469 · American Diagnostic Corp. · Nov 1980
RIA PHASE T4
K800203 · Boehringer Mannheim Corp. · Mar 1980
ANALYTE T4-THYROXINE
K800385 · Technicon Instruments Corp. · Mar 1980
AMERLEX T-4 RIA KIT
K800300 · Amersham Corp. · Mar 1980