Cleared Traditional

K822684 - ENDAB THYROID UPTAKE

K822684 is the FDA 510(k) clearance for ENDAB THYROID UPTAKE by Immunotech Corp.. It is a Class 2 Microbiology device (product code CEE) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K822684 · Immunotech Corp. · Microbiology device

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Oct 1982

Decision

35d

Days

Class 2

Risk

K822684 is an FDA 510(k) clearance for the ENDAB THYROID UPTAKE. Classified as Radioimmunoassay, Thyroxine-binding Globulin (product code CEE), Class II - Special Controls.

Submitted by Immunotech Corp. (Mchenry, US). The FDA issued a Cleared decision on October 8, 1982 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.1685 - the FDA microbiology device 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 Immunotech Corp. devices

Submission Details

510(k) Number	K822684 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 03, 1982
Decision Date	October 08, 1982
Days to Decision	35 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

67d faster than avg

Panel avg: 102d · This submission: 35d

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 Microbiology devices follow this clearance model.

Regulatory Peers - CEE Radioimmunoassay, Thyroxine-binding Globulin

All 16

Devices cleared under the same product code (CEE) and FDA review panel - the closest regulatory comparables to K822684.

ENZYMUN TEST TBG

K862109 · Boehringer Mannheim Corp. · Jun 1986

THYROXINE-BINDING GLOBULIN RADIOUMMU

K842010 · Nichols Institute Diagnostics · Jun 1984

VENTREZYME T4U IMMUNOASSAY T4U

K841024 · Ventrex Laboratories, Inc. · May 1984

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

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K822684

Immunotech Corp.

Mchenry, IL · US

Regulatory profile

37 submissions 37 cleared

100% clearance rate · Active in Microbiology

Data Intelligence Layer

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Sourced from FDA 510(k) public files . Updated monthly.

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