Cleared Traditional

K820252 - TBG DIAGNOSTIC KIT

K820252 is the FDA 510(k) clearance for TBG DIAGNOSTIC KIT by Diagnostic Reagents, Inc.. It is a Class 2 Chemistry device (product code CEE) cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K820252 · Diagnostic Reagents, Inc. · Chemistry device
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May 1982
Decision
96d
Days
Class 2
Risk

K820252 is an FDA 510(k) clearance for the TBG DIAGNOSTIC KIT. Classified as Radioimmunoassay, Thyroxine-binding Globulin (product code CEE), Class II - Special Controls.

Submitted by Diagnostic Reagents, Inc. (Walker, US). The FDA issued a Cleared decision on May 5, 1982 after a review of 96 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostic Reagents, Inc. devices

Submission Details

510(k) Number K820252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1982
Decision Date May 05, 1982
Days to Decision 96 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
8d slower than avg
Panel avg: 88d · This submission: 96d
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 15
Devices cleared under the same product code (CEE) and FDA review panel - the closest regulatory comparables to K820252.
THYROXINE-BINDING GLOBULIN RADIOUMMU
K842010 · Nichols Institute Diagnostics · Jun 1984
VENTREZYME T4U IMMUNOASSAY T4U
K841024 · Ventrex Laboratories, Inc. · May 1984
ENDAB THYROID UPTAKE
K822684 · Immunotech Corp. · Oct 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