Cleared Traditional

K943019 - CEDIA T4 MAB ASSAY

K943019 is an FDA 510(k) clearance for CEDIA T4 MAB ASSAY, manufactured by Microgenics Corp.. The device is a Class 2 Chemistry device with product code KLI cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K943019 · Microgenics Corp. · Chemistry device
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Oct 1994
Decision
118d
Days
Class 2
Risk

K943019 is an FDA 510(k) clearance for the CEDIA T4 MAB ASSAY. Classified as Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (product code KLI), Class II - Special Controls.

Submitted by Microgenics Corp. (Concord, US). The FDA issued a Cleared decision on October 20, 1994 after a review of 118 days - within the typical 510(k) review window.

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: 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 Microgenics Corp. devices

FDA 510(k) Submission Details - K943019

510(k) Number K943019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1994
Decision Date October 20, 1994
Days to Decision 118 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 88d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLI Device Classification - Class 2, Special Controls

Product Code KLI Enzyme Immunoassay, Non-radiolabeled, 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 - KLI Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine

All 70
Devices cleared under the same product code (KLI) and FDA review panel - the closest regulatory comparables to K943019.
RADIAS NEONATAL T4 ENZYME IMMUNOASSAY
K951321 · Bio-Rad · Aug 1995
RADIAS TOTAL T4 ENZYME IMMUNOASSAY
K946163 · Bio-Rad · Feb 1995
THYROXINE ENZYME IMMUNOASSAY
K944703 · Diagnostic Reagents, Inc. · Dec 1994
CEDIA T4 MAB ASSAY
K942575 · Microgenics Corp. · Jul 1994
CEDIA T4 MAB ASSAY
K941042 · Microgenics Corp. · Apr 1994
CEDIA T4 MAB ASSAY MODIFICATION
K935880 · Microgenics Corp. · Mar 1994