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FDA 510(k)

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

K-Number: K251875 · 2025-10-27

ApplicantAffinity Biosensors, LLC
Decision Date2025-10-27
Product CodeSAN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system is a medical device manufactured by Affinity Biosensors, LLC. It received FDA 510(k) clearance on 2025-10-27 under approval number K251875. The device is classified under product code SAN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system?

LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system is a medical device that received FDA 510(k) clearance on 2025-10-27. It is manufactured by Affinity Biosensors, LLC. The 510(k) number is K251875.

When was LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system approved by the FDA?

LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system received FDA 510(k) clearance on 2025-10-27, under approval number K251875.

What company makes LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system?

LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system is manufactured by Affinity Biosensors, LLC.

What is the FDA product code for LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system?

The FDA product code for LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system is SAN.

Related Clinical Trials

NCT07608822 BIO|STREAM.CSP CLS NOT_YET_RECRUITING NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING NCT05378399 SmartSteps: A Context-Aware, PrEP Adherence Intervention for Individuals With Substance Use Disorder COMPLETED NCT06717308 Evaluation of a Switchable Acrylic Adhesive Drape for Safer Removal in Negative Pressure Wound Therapy Applications. RECRUITING NCT07527702 Low (-4) vs Physiologic (-8) Pressure Digital Continuous Suction After Lung Resection RECRUITING NCT06976125 Application of a Prediction Model for Directing Antibiotic Use in the Treatment of Urinary Tract Infection in an Ambulatory Setting RECRUITING

Related PubMed Literature

PMID: 40775863 Use of the Learning Health System to Redesign and Implement a Clinical Decision Support System for Antimicrobial Stewardship. Studies in health technology and informatics (2025)

Other Devices by Affinity Biosensors, LLC

K241324LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system

Related Devices (Code: SAN)

K241324LifeScale Gram Negative Kit (LSGN) with the LifeScale AST systemAffinity Biosensors, LLC K230675VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystemSpecific Diagnostics, LLC K221688ASTar BC G- Kit and ASTar InstrumentQ-Linea AB K211815LifeScale Gram Negative Kit (LSGN) with the LifeScale AST SystemAffinity Biosensors K253573ASTar BC G- KitQ-Linea AB

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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