Cleared Traditional

K230675 - VITEK REVEAL GN AST Assay and VITEK REVEAL AST System (FDA 510(k) Clearance)

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

K230675 · Specific Diagnostics, LLC · Microbiology device
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Jun 2024
Decision
468d
Days
Class 2
Risk

K230675 is an FDA 510(k) clearance for the VITEK REVEAL GN AST Assay and VITEK REVEAL AST System. Classified as Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples (product code SAN), Class II - Special Controls.

Submitted by Specific Diagnostics, LLC (San Jose, US). The FDA issued a Cleared decision on June 20, 2024 after a review of 468 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Specific Diagnostics, LLC devices

Submission Details

510(k) Number K230675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2023
Decision Date June 20, 2024
Days to Decision 468 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
366d slower than avg
Panel avg: 102d · This submission: 468d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code SAN Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1650
Definition Automated System That Performs Antimicrobial Susceptibility Testing Using Positive Blood Culture Samples
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.

Regulatory Consultant

MDC Associates
Katie Hahnemann

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - SAN Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples

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