Cleared Traditional

K771341 - SPINSEP-TBG

K771341 is an FDA 510(k) clearance for SPINSEP-TBG, 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 22-day FDA review.

K771341 · Nuclear Diagnostics, Inc. · Chemistry device
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Aug 1977
Decision
22d
Days
Class 2
Risk

K771341 is an FDA 510(k) clearance for the SPINSEP-TBG. 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 August 10, 1977 after a review of 22 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 - K771341

510(k) Number K771341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1977
Decision Date August 10, 1977
Days to Decision 22 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
66d faster than avg
Panel avg: 88d · This submission: 22d
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 K771341.
GLOBULIN TEST, HUMAN THYROXINE BINDING
K781225 · Hyland Therapeutic Div., Travenol Laboratories · Aug 1978
STIKSEP-T3 KIT
K780486 · Nuclear Diagnostics, Inc. · Apr 1978
THYROID BINDING GLOBULIN
K772183 · Corning Medical & Scientific · Dec 1977
PROCEDURE, RA, THYROXINE BINDING PROTEIN
K760134 · Bio-Rad · Jul 1976