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510(k) K213931

VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL) by bioMerieux, Inc. — Product Code LON

K213931 is an FDA 510(k) premarket notification submitted by bioMerieux, Inc. for the device "VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)". The FDA issued a decision of Substantially Equivalent on Jun 3, 2022. The device falls under product code LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation), a Class II device regulated under 21 CFR 866.1645. bioMerieux, Inc. has 270 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 3, 2022
Date Received
Dec 16, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device Class
Class II
Regulation Number
866.1645
Review Panel
MI
Submission Type
510(k)

Other clearances by bioMerieux, Inc.

  • K260160 — VITEK REVEAL GN AST Assay and VITEK REVEAL AST System (Jul 8, 2026)
  • K260282 — VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance (Apr 15, 2026)
  • K260281 — VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) (Mar 26, 2026)
  • K251579 — VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) (Aug 21, 2025)
  • K250274 — ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) (Apr 30, 2025)
  • K234012 — VITEK COMPACT PRO (Mar 14, 2025)
  • K232967 — VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) (Jun 12, 2024)
  • K232963 — VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) (Jun 7, 2024)
  • K240279 — VIDAS TBI (GFAP, UCH-L1) (May 1, 2024)
  • K234000 — VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) (Mar 11, 2024)

Other clearances for product code LON

  • K260282 — VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance (Apr 15, 2026)
  • K260281 — VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) (Mar 26, 2026)
  • K251579 — VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) (Aug 21, 2025)
  • K251713 — BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) (Aug 8, 2025)
  • K250447 — BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4… (May 19, 2025)
  • K234012 — VITEK COMPACT PRO (Mar 14, 2025)
  • K250344 — BD Phoenix™ Automated Microbiology System (Mar 6, 2025)
  • K233986 — BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL) (Mar 15, 2024)
  • K234000 — VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) (Mar 11, 2024)
  • K232756 — Colibrí (Dec 27, 2023)

FDA data resources