Cleared Traditional

K914025 - TECHNICON AXON(TM) SYSTEMS

K914025 is the FDA 510(k) clearance for TECHNICON AXON(TM) SYSTEMS by Technicon Instruments Corp.. It is a Class 2 Chemistry device (product code CIT) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K914025 · Technicon Instruments Corp. · Chemistry device
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Nov 1991
Decision
74d
Days
Class 2
Risk

K914025 is an FDA 510(k) clearance for the TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P). Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by Technicon Instruments Corp. (Tarrytown, US). The FDA issued a Cleared decision on November 22, 1991 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1100 - 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 K914025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1991
Decision Date November 22, 1991
Days to Decision 74 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 88d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CIT Nadh Oxidation/nad Reduction, Ast/sgot
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1100
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 - CIT Nadh Oxidation/nad Reduction, Ast/sgot

All 104
Devices cleared under the same product code (CIT) and FDA review panel - the closest regulatory comparables to K914025.
MILES ASPARTATE AMINOTRANSFERASE SERA-PAK METHOD
K920336 · Heraeus Kulzer, Inc. · Mar 1992
SYNERMED AST/GOT REAGENT KIT
K915555 · Synermed, Inc. · Jan 1992
ABBOTT QUICKSTART SGOT, ITEM NUMBER: 5A42
K914463 · Em Diagnostic Systems, Inc. · Jan 1992
ABBOTT QUICKSTART ASPARATE AMINOTRANSFERASE TEST
K914068 · Em Diagnostic Systems, Inc. · Oct 1991
COULTER DART AST (GOT) REAGENT
K905771 · Coulter Electronics, Inc. · Feb 1991
AST REAGENT
K903829 · Amresco, Inc. · Sep 1990