Cleared Traditional

K842010 - THYROXINE-BINDING GLOBULIN RADIOUMMU

K842010 is an FDA 510(k) clearance for THYROXINE-BINDING GLOBULIN RADIOUMMU, manufactured by Nichols Institute Diagnostics. The device is a Class 2 Chemistry device with product code CEE cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K842010 · Nichols Institute Diagnostics · Chemistry device
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Jun 1984
Decision
39d
Days
Class 2
Risk

K842010 is an FDA 510(k) clearance for the THYROXINE-BINDING GLOBULIN RADIOUMMU. Classified as Radioimmunoassay, Thyroxine-binding Globulin (product code CEE), Class II - Special Controls.

Submitted by Nichols Institute Diagnostics (Mchenry, US). The FDA issued a Cleared decision on June 25, 1984 after a review of 39 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 Nichols Institute Diagnostics devices

FDA 510(k) Submission Details - K842010

510(k) Number K842010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1984
Decision Date June 25, 1984
Days to Decision 39 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
49d faster than avg
Panel avg: 88d · This submission: 39d
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 K842010.
ENZYMUN TEST TBG
K862109 · Boehringer Mannheim Corp. · Jun 1986
TIPSEP-TBG ASSAY
K861735 · Nuclear Diagnostics, Inc. · Jun 1986
TBG RIA
K842167 · Syncor Intl. Corp. · Jul 1984
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