Cleared Traditional

K821141 - ENDAB T4 ENZYME IMMUNOASSAY KIT

K821141 is the FDA 510(k) clearance for ENDAB T4 ENZYME IMMUNOASSAY KIT by Immunotech Corp.. It is a Class 2 Immunology device (product code CDX) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K821141 · Immunotech Corp. · Immunology device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

May 1982

Decision

22d

Days

Class 2

Risk

K821141 is an FDA 510(k) clearance for the ENDAB T4 ENZYME IMMUNOASSAY KIT. Classified as Radioimmunoassay, Total Thyroxine (product code CDX), Class II - Special Controls.

Submitted by Immunotech Corp. (Mchenry, US). The FDA issued a Cleared decision on May 13, 1982 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1700 - the FDA immunology 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	K821141 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 21, 1982
Decision Date	May 13, 1982
Days to Decision	22 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

82d faster than avg

Panel avg: 104d · This submission: 22d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	CDX Radioimmunoassay, Total Thyroxine
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 862.1700

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 Immunology devices follow this clearance model.

Regulatory Peers - CDX Radioimmunoassay, Total Thyroxine

All 68

Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K821141.

MONOCLONAL ANTIBODY T4 RADIO-KIT

K823265 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1982

LEECO T4 QUANT DIAGNOSTICS TEST KIT

K822399 · Leeco Diagnostics, Inc. · Sep 1982

SPAC T4 RIA TEST KIT

K820725 · Mallinckrodt Critical Care · Jun 1982

QUANTAPHASE T-4 RIA

K811787 · Bio-Rad · Jul 1981

COAT-A-COUNT T4 RIA KIT

K811315 · Diagnostic Products Corp. · May 1981

IMMU-TRACE T4 RIA PROCEDURE

K803046 · American Dade · Jan 1981

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 K821141

Immunotech Corp.

Mchenry, IL · US

Regulatory profile

37 submissions 37 cleared

100% clearance rate · Active in Immunology

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

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

Verify on FDA.gov

510k Database

510(k) clearances indexed 175,730

Regulatory data since 1976

FDA monthly sync Active