Cleared Traditional

K231536 - eQUANT System (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231536 · Avails Medical, Inc. · Microbiology device
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Feb 2024
Decision
254d
Days
Class 2
Risk

K231536 is an FDA 510(k) clearance for the eQUANT System. Classified as Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing (product code QZX), Class II - Special Controls.

Submitted by Avails Medical, Inc. (Menlo Park, US). The FDA issued a Cleared decision on February 8, 2024 after a review of 254 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1650 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Avails Medical, Inc. devices

Submission Details

510(k) Number K231536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2023
Decision Date February 08, 2024
Days to Decision 254 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
152d slower than avg
Panel avg: 102d · This submission: 254d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QZX Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1650
Definition Processing Device That Includes Associated Reagents, When Applicable, That Is Intended To Recover Microbes From Positive Blood Cultures For Inoculum Preparation. The Prepared Inoculum Is Intended For Subsequent Use In Antimicrobial Susceptibility Testing.
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 Microbiology devices follow this clearance model.