Cleared Traditional

K222613 - ARX Liquid Amies Collection & Transport System (FDA 510(k) Clearance)

Class I Microbiology device.

K222613 · Arx Sciences, Inc. · Microbiology device
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Optimized for regulatory review, auditing and printing
Mar 2024
Decision
575d
Days
Class 1
Risk

K222613 is an FDA 510(k) clearance for the ARX Liquid Amies Collection & Transport System. Classified as Device, Specimen Collection (product code LIO), Class I - General Controls.

Submitted by Arx Sciences, Inc. (Amherst, US). The FDA issued a Cleared decision on March 27, 2024 after a review of 575 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2900 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Arx Sciences, Inc. devices

Submission Details

510(k) Number K222613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2022
Decision Date March 27, 2024
Days to Decision 575 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
473d slower than avg
Panel avg: 102d · This submission: 575d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIO Device, Specimen Collection
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2900
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.