Cleared Traditional

K800384 - SMAC SYSTEM

K800384 is the FDA 510(k) clearance for SMAC SYSTEM by Technicon Instruments Corp.. It is a Class 2 Chemistry device (product code KLI) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K800384 · Technicon Instruments Corp. · Chemistry device
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Mar 1980
Decision
26d
Days
Class 2
Risk

K800384 is an FDA 510(k) clearance for the SMAC SYSTEM, T4 METHOD. Classified as Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (product code KLI), Class II - Special Controls.

Submitted by Technicon Instruments Corp. (Mchenry, US). The FDA issued a Cleared decision on March 19, 1980 after a review of 26 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 Technicon Instruments Corp. devices

Submission Details

510(k) Number K800384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1980
Decision Date March 19, 1980
Days to Decision 26 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
62d faster than avg
Panel avg: 88d · This submission: 26d
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 K800384.
OREIA-Q-TY, ENZYME IMMUNOASSAY
K802693 · Organon, Inc. · Dec 1980
APPLICATION OF EMIT AED ASSAYS
K801475 · Syva Co. · Jul 1980
EMIT AAII THYROXINE ASSAY
K801288 · Syva Co. · Jun 1980
A-GENT QUANTICHROM T4 11A
K790848 · Abbott Laboratories · Aug 1979
EMIT CFA THYROXINE ASSAY
K790686 · Syva Co. · May 1979
EMIT THYROXINE ASSAY
K782085 · Syva Co. · Feb 1979