Cleared Traditional

K935880 - CEDIA T4 MAB ASSAY MODIFICATION

K935880 is the FDA 510(k) clearance for CEDIA T4 MAB ASSAY MODIFICATION by Microgenics Corp.. It is a Class 2 Chemistry device (product code KLI) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K935880 · Microgenics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
87d
Days
Class 2
Risk

K935880 is an FDA 510(k) clearance for the CEDIA T4 MAB ASSAY MODIFICATION. 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 March 3, 1994 after a review of 87 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 K935880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1993
Decision Date March 03, 1994
Days to Decision 87 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
1d faster than avg
Panel avg: 88d · This submission: 87d
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 K935880.
CEDIA T4 MAB ASSAY
K943019 · Microgenics Corp. · Oct 1994
CEDIA T4 MAB ASSAY
K942575 · Microgenics Corp. · Jul 1994
CEDIA T4 MAB ASSAY
K941042 · Microgenics Corp. · Apr 1994
COBAS (R) CORE T4 EIA
K932605 · Roche Diagnostic Systems, Inc. · Jan 1994
ACCESS(R) THYROXINE ASSAY
K926475 · Bio-Rad Laboratories, Inc. · Jun 1993
VIDAS THYROXINE (T4) ASSAY (T4)
K926393 · Biomerieux Vitek, Inc. · May 1993