Cleared Traditional

K884634 - MODIFIED CEDIA TOTAL T4 ASSAY

K884634 is the FDA 510(k) clearance for MODIFIED CEDIA TOTAL T4 ASSAY by Microgenics Corp.. It is a Class 2 Chemistry device (product code KLI) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K884634 · Microgenics Corp. · Chemistry device
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Dec 1988
Decision
32d
Days
Class 2
Risk

K884634 is an FDA 510(k) clearance for the MODIFIED CEDIA TOTAL T4 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 December 9, 1988 after a review of 32 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 K884634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1988
Decision Date December 09, 1988
Days to Decision 32 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
56d faster than avg
Panel avg: 88d · This submission: 32d
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 K884634.
EMIT CONVENIENCE PACK: THYROXINE ASSAY
K890831 · Syva Co. · Apr 1989
THYROXINE MICROASSAY
K884260 · Diamedix Corp. · Feb 1989
EMIT THYROXINE ASSAY
K885141 · Syva Co. · Feb 1989
EMIT CONVENIENCE PACK: THYROXINE ASSAY
K881357 · Syva Co. · May 1988
EMIT THYROXINE ASSAY
K880620 · Syva Co. · Mar 1988
VISION(R) THYROXINE (T4)
K880662 · Abbott Laboratories · Mar 1988