Cleared Traditional

PhAST instrument and PhAST Blood Culture Gram-negative Panel (K253316) - FDA 510(k) Clearance

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

K253316 · Phast Corp. · Microbiology device
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Jun 2026
Decision
269d
Days
Class 2
Risk

K253316 is an FDA 510(k) clearance for the PhAST instrument and PhAST Blood Culture Gram-negative Panel. Classified as Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples (product code SAN), Class II - Special Controls.

Submitted by Phast Corp. (Boston, US). The FDA issued a Cleared decision on June 26, 2026 after a review of 269 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 Phast Corp. devices

Submission Details

510(k) Number K253316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2025
Decision Date June 26, 2026
Days to Decision 269 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
167d slower than avg
Panel avg: 102d · This submission: 269d
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 Peers - SAN Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples

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