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510(k) K260160

VITEK REVEAL GN AST Assay and VITEK REVEAL AST System by bioMerieux, Inc. — Product Code SAN

K260160 is an FDA 510(k) premarket notification submitted by bioMerieux, Inc. for the device "VITEK REVEAL GN AST Assay and VITEK REVEAL AST System". The FDA issued a decision of Substantially Equivalent on July 8, 2026. 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. bioMerieux, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2026
Date Received
January 20, 2026
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 bioMerieux, Inc.

  • K260282 — VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance (April 15, 2026)
  • K260281 — VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) (March 26, 2026)
  • K251579 — VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) (August 21, 2025)
  • K250274 — ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) (April 30, 2025)
  • K234012 — VITEK COMPACT PRO (March 14, 2025)
  • K232967 — VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) (June 12, 2024)
  • K232963 — VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) (June 7, 2024)
  • K240279 — VIDAS TBI (GFAP, UCH-L1) (May 1, 2024)
  • K234000 — VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) (March 11, 2024)
  • K232201 — VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus (October 23, 2023)

Other clearances for product code SAN

  • 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)
  • K211815 — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System (April 2, 2024)

FDA data resources