Cleared Traditional

K211815 - 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.

K211815 · Affinity Biosensors · Microbiology device
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Apr 2024
Decision
1026d
Days
Class 2
Risk

K211815 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 (Santa Barbara, US). The FDA issued a Cleared decision on April 2, 2024 after a review of 1026 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.

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Submission Details

510(k) Number K211815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2021
Decision Date April 02, 2024
Days to Decision 1026 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
924d slower than avg
Panel avg: 102d · This submission: 1026d
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

Devices cleared under the same product code (SAN) and FDA review panel - the closest regulatory comparables to K211815.
ASTar BC G- Kit
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LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
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