Cleared Traditional

K900905 - TECHNICON AXON SYSTEM REAGENT METHODS

K900905 is the FDA 510(k) clearance for TECHNICON AXON SYSTEM REAGENT METHODS by Technicon Instruments Corp.. It is a Class 1 Chemistry device (product code CKA) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K900905 · Technicon Instruments Corp. · Chemistry device
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Apr 1990
Decision
35d
Days
Class 1
Risk

K900905 is an FDA 510(k) clearance for the TECHNICON AXON SYSTEM REAGENT METHODS. Classified as Nadh Oxidation/nad Reduction, Alt/sgpt (product code CKA), Class I - General Controls.

Submitted by Technicon Instruments Corp. (Tarrytown, US). The FDA issued a Cleared decision on April 3, 1990 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1030 - 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 K900905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1990
Decision Date April 03, 1990
Days to Decision 35 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
53d faster than avg
Panel avg: 88d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CKA Nadh Oxidation/nad Reduction, Alt/sgpt
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1030
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CKA Nadh Oxidation/nad Reduction, Alt/sgpt

All 97
Devices cleared under the same product code (CKA) and FDA review panel - the closest regulatory comparables to K900905.
COULTER DART ALT (GPT) REAGENT
K905767 · Coulter Electronics, Inc. · Jan 1991
ALANINE AMINOTRANSFERASE TEST
K903198 · Em Diagnostic Systems, Inc. · Sep 1990
NAD REDUCTION, ALT/SPGT CODES 7722,7723,7422,7522
K901702 · American Research Products Co. · Apr 1990
PARAMAX ALANINE AMINOTRANSFERASE REAGENT
K901105 · Baxter Healthcare Corp · Mar 1990
COULTER ALT (GPT) REAGENT
K897163 · Coulter Electronics, Inc. · Mar 1990
COBAS READY STAT PROFILE REAGENT STRIP
K896234 · Roche Diagnostic Systems, Inc. · Feb 1990