Cleared Traditional

K251875 - LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system (FDA 510(k) Clearance)

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

K251875 · Affinity Biosensors, LLC · Microbiology device
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Oct 2025
Decision
131d
Days
Class 2
Risk

K251875 is an FDA 510(k) clearance for the LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system. Classified as Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples (product code SAN), Class II - Special Controls.

Submitted by Affinity Biosensors, LLC (Santa Barbara, US). The FDA issued a Cleared decision on October 27, 2025 after a review of 131 days - within the typical 510(k) review window.

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 Affinity Biosensors, LLC devices

Submission Details

510(k) Number K251875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2025
Decision Date October 27, 2025
Days to Decision 131 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 102d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. PCCP authorized - AI/SaMD pathway.

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

Devices cleared under the same product code (SAN) and FDA review panel - the closest regulatory comparables to K251875.
ASTar BC G- Kit
K253573 · Q-Linea AB · Apr 2026
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
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K230675 · Specific Diagnostics, LLC · Jun 2024
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K221688 · Q-Linea AB · Apr 2024
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System
K211815 · Affinity Biosensors · Apr 2024