Cleared Traditional

K941042 - CEDIA T4 MAB ASSAY

K941042 is the FDA 510(k) clearance for CEDIA T4 MAB ASSAY by Microgenics Corp.. It is a Class 2 Chemistry device (product code KLI) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K941042 · Microgenics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
50d
Days
Class 2
Risk

K941042 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 April 26, 1994 after a review of 50 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 Microgenics Corp. devices

Submission Details

510(k) Number K941042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1994
Decision Date April 26, 1994
Days to Decision 50 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
38d faster than avg
Panel avg: 88d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 56
Devices cleared under the same product code (KLI) and FDA review panel - the closest regulatory comparables to K941042.
THYROXINE ENZYME IMMUNOASSAY
K944703 · Diagnostic Reagents, Inc. · Dec 1994
CEDIA T4 MAB ASSAY
K943019 · Microgenics Corp. · Oct 1994
CEDIA T4 MAB ASSAY
K942575 · Microgenics Corp. · Jul 1994
CEDIA T4 MAB ASSAY MODIFICATION
K935880 · Microgenics Corp. · Mar 1994
COBAS (R) CORE T4 EIA
K932605 · Roche Diagnostic Systems, Inc. · Jan 1994
ACCESS(R) THYROXINE ASSAY
K926475 · Bio-Rad Laboratories, Inc. · Jun 1993