510(k) K162385

RAPIDEC CARBA NP by Biomerieux S.A. — Product Code PTJ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 27, 2017
Date Received: August 25, 2016
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates
Device Class: Class II
Regulation Number: 866.1640
Review Panel: MI
Submission Type

Qualitative detection of carbapenemase enzymes in pure colonies of Enterobacteriaceae and Pseudomonas aeruginosa that have elevated MIC values to any Carbapenem

Other clearances by Biomerieux S.A.

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)

510(k) K162385

Clearance Details

Device Classification

Other clearances by Biomerieux S.A.

Other clearances for product code PTJ