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510(k) K230675

VITEK REVEAL GN AST Assay and VITEK REVEAL AST System by Specific Diagnostics, LLC — Product Code SAN

K230675 is an FDA 510(k) premarket notification submitted by Specific Diagnostics, LLC for the device "VITEK REVEAL GN AST Assay and VITEK REVEAL AST System". The FDA issued a decision of Substantially Equivalent on June 20, 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2024
Date Received
March 10, 2023
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 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)
  • 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)

FDA data resources