Cleared Traditional

K864452 - DELFIA(TM) TRIIODOTHYRONINE (T3) KIT

K864452 is the FDA 510(k) clearance for DELFIA(TM) TRIIODOTHYRONINE (T3) KIT by Lkb Instruments, Inc.. It is a Class 2 Chemistry device (product code CDP) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K864452 · Lkb Instruments, Inc. · Chemistry device
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Feb 1987
Decision
82d
Days
Class 2
Risk

K864452 is an FDA 510(k) clearance for the DELFIA(TM) TRIIODOTHYRONINE (T3) KIT. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Lkb Instruments, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on February 2, 1987 after a review of 82 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 Lkb Instruments, Inc. devices

Submission Details

510(k) Number K864452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1986
Decision Date February 02, 1987
Days to Decision 82 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
6d faster than avg
Panel avg: 88d · This submission: 82d
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 K864452.
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