LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System

Q: What is the product code of K211815?

The FDA product code is SAN – Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples, a Class II (moderate risk) device regulated under 21 CFR 866.1650.

FDA 510(k) K211815 · Affinity Biosensors

Substantially Equivalent

510(k) numberK211815

Submission

Device name: LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System
Applicant: Affinity Biosensors
Santa Barbara, CA, US
Received: June 11, 2021
Decision date: April 2, 2024
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: SAN – Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.1650
Specialty: Microbiology

Automated system that performs antimicrobial susceptibility testing using positive blood culture samples

Other 510(k)s with product code SAN

510(k)	Device	Applicant	Decision
K260160	VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystemSAN · Traditional	bioMerieux, Inc.	07/08/2026SE
K253316	PhAST instrument and PhAST Blood Culture Gram-negative PanelSAN · Traditional	Phast Corp.	06/26/2026SE
K253573	ASTar BC G- KitSAN · Traditional	Q-Linea AB	04/15/2026SE
K251875	LifeScale Gram Negative Kit (LSGN) with the LifeScale AST systemSAN · Traditional	Affinity Biosensors, LLC	10/27/2025SE
K241324	LifeScale Gram Negative Kit (LSGN) with the LifeScale AST systemSAN · Traditional	Affinity Biosensors, LLC	10/23/2024SE
K230675	VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystemSAN · Traditional	Specific Diagnostics, LLC	06/20/2024SE
K221688	ASTar BC G- Kit and ASTar InstrumentSAN · Traditional	Q-Linea AB	04/26/2024SE

More from Q-Linea AB

510(k)	Device	Decision
K251875	LifeScale Gram Negative Kit (LSGN) with the LifeScale AST systemSAN · Traditional	10/27/2025SE
K241324	LifeScale Gram Negative Kit (LSGN) with the LifeScale AST systemSAN · Traditional	10/23/2024SE

Questions and answers

When was LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System cleared by the FDA?

LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System (K211815) received a 510(k) decision of Substantially Equivalent on April 2, 2024, 1,026 days after the submission was received.

What is the product code of K211815?

The FDA product code is SAN – Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples, a Class II (moderate risk) device regulated under 21 CFR 866.1650.