Cleared Traditional

K902922 - MICROZYME T4 ENZYME IMMUNOASSAY KIT

K902922 is the FDA 510(k) clearance for MICROZYME T4 ENZYME IMMUNOASSAY KIT by Immunotech Corp.. It is a Class 2 Chemistry device (product code CDX) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K902922 · Immunotech Corp. · Chemistry device

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Jul 1990

Decision

24d

Days

Class 2

Risk

K902922 is an FDA 510(k) clearance for the MICROZYME T4 ENZYME IMMUNOASSAY KIT. Classified as Radioimmunoassay, Total Thyroxine (product code CDX), Class II - Special Controls.

Submitted by Immunotech Corp. (Boston, US). The FDA issued a Cleared decision on July 27, 1990 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1700 - 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 Immunotech Corp. devices

Submission Details

510(k) Number	K902922 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 03, 1990
Decision Date	July 27, 1990
Days to Decision	24 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

64d faster than avg

Panel avg: 88d · This submission: 24d

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 Chemistry 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 K902922.

MILENIA TOTAL T4, CATALOG: MKT41,5

K912541 · Diagnostic Products Corp. · Aug 1991

THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM

K904816 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1991

CIBA CORNING ACS T4 IMMUNOASSAY

K905532 · Ciba Corning Diagnostics Corp. · Jan 1991

CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4

K901475 · Baxter Healthcare Corp · Jun 1990

TECHNICON RA SYSTEM THYROXINE T4 METHOD

K894575 · Technicon Instruments Corp. · Oct 1989

DELFIA THYROXINE (T4) KIT

K883559 · Pharmacia, Inc. · Dec 1988

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 K902922

Immunotech Corp.

Boston, MA · US

FRANCIS E CAPITANIO

Regulatory profile

37 submissions 37 cleared

100% clearance rate · Active in Chemistry

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