Cleared Traditional

K771854 - SPINSEP-T3

K771854 is an FDA 510(k) clearance for SPINSEP-T3, manufactured by Nuclear Diagnostics, Inc.. The device is a Class 2 Immunology device with product code KHQ cleared through the Traditional 510(k) pathway after a 85-day FDA review.

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

FDA 510(k) Submission Details - K771854

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 105d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KHQ Device Classification - Class 2, Special Controls

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 73
Devices cleared under the same product code (KHQ) and FDA review panel - the closest regulatory comparables to K771854.
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AMES T-3 UPTAKE STRIP TEST
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K771078 · Pharmacia, Inc. · Jun 1977
T3 UPTAKE REAGENT SET
K770845 · The Dow Chemical Co. · May 1977