Cleared Traditional

SPINSEP-T3 (K771854) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K771854 · Nuclear Diagnostics, Inc. · Immunology device
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Dec 1977
Decision
85d
Days
Class 2
Risk

K771854 is an FDA 510(k) clearance for the SPINSEP-T3. Classified as Radioassay, Triiodothyronine Uptake (product code KHQ), Class II - Special Controls.

Submitted by Nuclear Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 22, 1977 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1715 - the FDA immunology 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 Nuclear Diagnostics, Inc. devices

Submission Details

510(k) Number K771854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1977
Decision Date December 22, 1977
Days to Decision 85 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 104d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KHQ Radioassay, Triiodothyronine Uptake
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1715
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 Immunology devices follow this clearance model.

Regulatory Peers - KHQ Radioassay, Triiodothyronine Uptake

All 26
Devices cleared under the same product code (KHQ) and FDA review panel - the closest regulatory comparables to K771854.
RIA, T3 UPTAKE SOLID PHASE
K781662 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1978
CLINIRIA T-3 UPTAKE TEST
K781180 · Miles Laboratories, Inc. · Aug 1978
REAGENT SYSTEM, ARIA II T3 UPTAKE
K780253 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1978
AMES T-3 UPTAKE STRIP TEST
K772088 · Miles Laboratories, Inc. · Dec 1977
T-3 UPTAKE KIT
K760802 · Diagnostic Products Corp. · Oct 1976