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510(k) K240279

VIDAS TBI (GFAP, UCH-L1) by bioMerieux, Inc. — Product Code QAT

K240279 is an FDA 510(k) premarket notification submitted by bioMerieux, Inc. for the device "VIDAS TBI (GFAP, UCH-L1)". The FDA issued a decision of Substantially Equivalent on May 1, 2024. The device falls under product code QAT (Brain Trauma Assessment Test), a Class II device regulated under 21 CFR 866.5830. bioMerieux, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2024
Date Received
February 1, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Brain Trauma Assessment Test
Device Class
Class II
Regulation Number
866.5830
Review Panel
IM
Submission Type

Intended for in vitro diagnostic use as an aid in the evaluation of patients with suspected mild traumatic brain injury (TBI) in conjunction with other clinical information to assist in determining the need for radiologic (e.g., CT, MR) head imaging per current standard of care

Other clearances by bioMerieux, Inc.

  • K260160 — VITEK REVEAL GN AST Assay and VITEK REVEAL AST System (July 8, 2026)
  • 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)
  • 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 QAT

  • K234143 — i-STAT TBI Cartridge with the i-STAT Alinity System (March 27, 2024)
  • K232669 — TBI (September 29, 2023)
  • K223602 — Traumatic brain injury (TBI) test (March 2, 2023)
  • K201778 — i-STAT TBI Plasma cartridge with the i-STAT Alinity System (January 8, 2021)
  • DEN170045 — Banyan BTI (February 14, 2018)

FDA data resources