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510(k) K241324

LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system by Affinity Biosensors, LLC — Product Code SAN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2024
Date Received
May 10, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
Device Class
Class II
Regulation Number
866.1650
Review Panel
MI
Submission Type

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

Other clearances by Affinity Biosensors, LLC

  • K251875 — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system (October 27, 2025)
  • K211815 — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System (April 2, 2024)

Other clearances for product code SAN

  • K253573 — ASTar BC G- Kit (April 15, 2026)
  • K251875 — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system (October 27, 2025)
  • K230675 — VITEK REVEAL GN AST Assay and VITEK REVEAL AST System (June 20, 2024)
  • K221688 — ASTar BC G- Kit and ASTar Instrument (April 26, 2024)
  • K211815 — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System (April 2, 2024)