Cleared Traditional

K811070 - 125 I-T4 RIA TEST KIT

K811070 is the FDA 510(k) clearance for 125 I-T4 RIA TEST KIT by Intl. Immunoassay Laboratories, Inc.. It is a Class 2 Chemistry device (product code CDX) cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K811070 · Intl. Immunoassay Laboratories, Inc. · Chemistry device
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Apr 1981
Decision
9d
Days
Class 2
Risk

K811070 is an FDA 510(k) clearance for the 125 I-T4 RIA TEST KIT. Classified as Radioimmunoassay, Total Thyroxine (product code CDX), Class II - Special Controls.

Submitted by Intl. Immunoassay Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 29, 1981 after a review of 9 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 Intl. Immunoassay Laboratories, Inc. devices

Submission Details

510(k) Number K811070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1981
Decision Date April 29, 1981
Days to Decision 9 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 88d · This submission: 9d
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 69
Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K811070.
ENDAB T4 ENZYME IMMUNOASSAY KIT
K821141 · Immunotech Corp. · May 1982
QUANTAPHASE T-4 RIA
K811787 · Bio-Rad · Jul 1981
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
THYROXINE RADIOIMMUNOASSAY KIT
K801105 · Calbiochem-Behring Corp. · Jun 1980