Cleared Traditional

K810967 - IN-VITRO TBG RADIOIMMUNOASSAY TEST

K810967 is the FDA 510(k) clearance for IN-VITRO TBG RADIOIMMUNOASSAY TEST by Clinical Assays, Inc.. It is a Class 2 Chemistry device (product code CEE) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K810967 · Clinical Assays, Inc. · Chemistry device
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Apr 1981
Decision
15d
Days
Class 2
Risk

K810967 is an FDA 510(k) clearance for the IN-VITRO TBG RADIOIMMUNOASSAY TEST. Classified as Radioimmunoassay, Thyroxine-binding Globulin (product code CEE), Class II - Special Controls.

Submitted by Clinical Assays, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 23, 1981 after a review of 15 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 Clinical Assays, Inc. devices

Submission Details

510(k) Number K810967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1981
Decision Date April 23, 1981
Days to Decision 15 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 88d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 18
Devices cleared under the same product code (CEE) and FDA review panel - the closest regulatory comparables to K810967.
VENTREZYME T4U IMMUNOASSAY T4U
K841024 · Ventrex Laboratories, Inc. · May 1984
ENDAB THYROID UPTAKE
K822684 · Immunotech Corp. · Oct 1982
TBG DIAGNOSTIC KIT
K820252 · Diagnostic Reagents, Inc. · May 1982
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