VIDAS NT-PROBNP ASSAY, MODEL: 30 449— 510(k) K073091

Clearance details

Applicant

bioMerieux, Inc.

Product code

Code NBC

Device class

Class 2

Regulation

21 CFR 862.1117

Advisory panel

Clinical Chemistry

Date received

2007-11-01

Decision date

2008-02-29

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hazelwood, MO, US

• K252169 — Access BNP II2026-03-24
• K253539 — Alere NT-proBNP for Alinity i2026-02-18
• K241176 — Alere NT-proBNP for Alinity i Reagent Kit2025-01-16
• K232164 — Access NT-proBNP2024-04-12
• K220265 — ADVIA Centaur® NT-proBNPII (PBNPII)2023-09-24

• K260160 — VITEK REVEAL GN AST Assay and VITEK REVEAL AST System2026-07-08
• K260282 — VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance2026-04-15
• K251579 — VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)2025-08-21
• K234012 — VITEK COMPACT PRO2025-03-14
• K232967 — VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)2024-06-12

• Z-2779-2016 — VIDAS NT-pro-BNP Product Usage: VIDAS¿ NTproBNP (PBNP) is an automated quantitative test for use on the instruments of the VIDAS family for the determination of N terminal fragment of Btype natriuretic peptide in human serum or plasma (lithium heparin) using the ELFA technique (EnzymeLinked Fluorescent Assay). The VIDAS NTproBNP (PBNP) test is used as an aid in the diagnosis of suspected congestive heart failure.Class III·Terminated·Biomerieux France Chemin De L'Or·20160415

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K073091.