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510(k) K211815

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

K211815 is an FDA 510(k) premarket notification submitted by Affinity Biosensors for the device "LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System". The FDA issued a decision of Substantially Equivalent on April 2, 2024. The device falls under product code SAN (Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples), a Class II device regulated under 21 CFR 866.1650. Affinity Biosensors has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2024
Date Received
June 11, 2021
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

  • K251875 — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system (October 27, 2025)
  • K241324 — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system (October 23, 2024)

Other clearances for product code SAN

  • K260160 — VITEK REVEAL GN AST Assay and VITEK REVEAL AST System (July 8, 2026)
  • K253316 — PhAST instrument and PhAST Blood Culture Gram-negative Panel (June 26, 2026)
  • K253573 — ASTar BC G- Kit (April 15, 2026)
  • K251875 — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system (October 27, 2025)
  • K241324 — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system (October 23, 2024)
  • 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)

FDA data resources