Cleared Traditional

K905410 - OPUS T3 TEST SYSTEM

K905410 is the FDA 510(k) clearance for OPUS T3 TEST SYSTEM by Pb Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (product code CDP) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K905410 · Pb Diagnostic Systems, Inc. · Toxicology device
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Feb 1991
Decision
63d
Days
Class 2
Risk

K905410 is an FDA 510(k) clearance for the OPUS T3 TEST SYSTEM. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Pb Diagnostic Systems, Inc. (Westwood, US). The FDA issued a Cleared decision on February 4, 1991 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1710 - the FDA toxicology device 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 Pb Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K905410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1990
Decision Date February 04, 1991
Days to Decision 63 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 87d · This submission: 63d
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 Toxicology 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 K905410.
TOTAL T3 CHEMILUMINESCENCE ASSAY
K923015 · Nichols Institute Diagnostics · Sep 1992
MILENIA TOTAL T3
K914467 · Diagnostic Products Corp. · Feb 1992
DOCUMENT CK ISOENZYMES CONTROL
K915792 · Casco Standards · Feb 1992
IMX FREE TRIIODOTHYRONINE
K905261 · Abbott Laboratories · Jan 1991
MICROZYME T3 ENZYME IMMUNOASSAY KIT
K904820 · Immunotech Corp. · Dec 1990
TDX FREE T3 CALCULATION
K903433 · Abbott Laboratories · Oct 1990