Cleared Traditional

K780486 - STIKSEP-T3 KIT

K780486 is an FDA 510(k) clearance for STIKSEP-T3 KIT, manufactured by Nuclear Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code CEE cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K780486 · Nuclear Diagnostics, Inc. · Chemistry device
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Apr 1978
Decision
32d
Days
Class 2
Risk

K780486 is an FDA 510(k) clearance for the STIKSEP-T3 KIT. Classified as Radioimmunoassay, Thyroxine-binding Globulin (product code CEE), Class II - Special Controls.

Submitted by Nuclear Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 28, 1978 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1685 - 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 Nuclear Diagnostics, Inc. devices

FDA 510(k) Submission Details - K780486

510(k) Number K780486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1978
Decision Date April 28, 1978
Days to Decision 32 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 88d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CEE Device Classification - Class 2, Special Controls

Product Code CEE Radioimmunoassay, Thyroxine-binding Globulin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1685
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 - CEE Radioimmunoassay, Thyroxine-binding Globulin

All 22
Devices cleared under the same product code (CEE) and FDA review panel - the closest regulatory comparables to K780486.
IN-VITRO TBG RADIOIMMUNOASSAY TEST
K810967 · Clinical Assays, Inc. · Apr 1981
RIA PHASE TBG
K800204 · Boehringer Mannheim Corp. · Mar 1980
GLOBULIN TEST, HUMAN THYROXINE BINDING
K781225 · Hyland Therapeutic Div., Travenol Laboratories · Aug 1978
THYROID BINDING GLOBULIN
K772183 · Corning Medical & Scientific · Dec 1977
SPINSEP-TBG
K771341 · Nuclear Diagnostics, Inc. · Aug 1977
PROCEDURE, RA, THYROXINE BINDING PROTEIN
K760134 · Bio-Rad · Jul 1976