Cleared Traditional

K810798 - TECHNICON STAR SYSTEM T3 RIA METHOD

K810798 is the FDA 510(k) clearance for TECHNICON STAR SYSTEM T3 RIA METHOD by Technicon Instruments Corp.. It is a Class 2 Chemistry device (product code CDP) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K810798 · Technicon Instruments Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1981
Decision
15d
Days
Class 2
Risk

K810798 is an FDA 510(k) clearance for the TECHNICON STAR SYSTEM T3 RIA METHOD. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Technicon Instruments Corp. (Mchenry, US). The FDA issued a Cleared decision on April 7, 1981 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1710 - 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 Technicon Instruments Corp. devices

Submission Details

510(k) Number K810798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1981
Decision Date April 07, 1981
Days to Decision 15 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
73d faster than avg
Panel avg: 88d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDP Radioimmunoassay, Total Triiodothyronine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1710
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 - CDP Radioimmunoassay, Total Triiodothyronine

All 91
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K810798.
ENZYM-LINKED T3
K820763 · Icl Scientific · Apr 1982
QUANTICOAT NEONATAL 125 T4 RADIOIMMUNO
K812611 · Kallestad Laboratories, Inc. · Oct 1981
COAT-A-COUNT T3 RIA KIT
K812246 · Diagnostic Products Corp. · Aug 1981
T3 RIABEAD DIAGNOSTIC KIT
K803261 · Abbott Laboratories · Jan 1981
T3 RADIOIMMUNOASSAY KIT
K802470 · American Diagnostic Corp. · Nov 1980
TRIIODOTHYRONINE RADIOIMMUN. SYSTEM
K801123 · Calbiochem-Behring Corp. · Jun 1980