Cleared Traditional

K820252 - TBG DIAGNOSTIC KIT

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

K820252 · Diagnostic Reagents, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K820252

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.

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 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
IN-VITRO TBG RADIOIMMUNOASSAY TEST
K810967 · Clinical Assays, Inc. · Apr 1981
RIA PHASE TBG
K800204 · Boehringer Mannheim Corp. · Mar 1980
GLOBULIN TEST, HUMAN THYROXINE BINDING
K781225 · Hyland Therapeutic Div., Travenol Laboratories · Aug 1978