Cleared Traditional

K971779 - TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA

K971779 is the FDA 510(k) clearance for TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA by Monobind. It is a Class 2 Chemistry device (product code CDP) cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K971779 · Monobind · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
33d
Days
Class 2
Risk

K971779 is an FDA 510(k) clearance for the TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Monobind (Costa Mesa, US). The FDA issued a Cleared decision on June 16, 1997 after a review of 33 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 Monobind devices

Submission Details

510(k) Number K971779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1997
Decision Date June 16, 1997
Days to Decision 33 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 88d · This submission: 33d
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 97
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K971779.
ABBOTT ARCHITECT FREE T3
K983439 · Abbott Laboratories · Nov 1998
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K974634 · Diagnostic Products Corp. · Jan 1998
ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
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DSL ACTIVE T3 EIA
K971270 · Diagnostic Systems Laboratories, Inc. · May 1997
NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T3 KIT
K965058 · Nichols Institute Diagnostics · Mar 1997
VITROS IMMUNODIAGNOSITCS PRODUCTS-FREE T3 REAGENT PACK (GEM.1020)/FREE T3 CALIBRATORS (GEM.C020)
K970016 · Johnson & Johnson Clinical Diagnostics, Inc. · Jan 1997