BD MAX GBS ASSAY, BD MAX INSTRUMENT— 510(k) K111860

Clearance details

Applicant

Becton, Dickinson & CO

Product code

Code NJR

Device class

Class 1

Regulation

21 CFR 866.3740

Advisory panel

Microbiology

Date received

2011-06-30

Decision date

2012-02-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Sparks, MD, US

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• Z-0238-2026 — BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MAX Instrument, Catalog Numbers: 44191609, 441927.Class II·Ongoing·Becton Dickinson & Co.·20250923
• Z-1004-2025 — BD PCR Cartridges used with MAX System. Model Number: 437519Class II·Ongoing·Becton Dickinson & Co.·20241219
• Z-0590-2025 — BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916Class II·Ongoing·Becton Dickinson & Co.·20241031
• Z-1864-2017 — Software version 4.44A utilized on the BD MAX SystemClass II·Terminated·BD LIFE SCIENCES·20150729
• Z-1662-2013 — BD MAX Instrument, catalog #441916 Product Usage: The BD MAX System, used in conjunction with the appropriate extraction kits and reagents is capable of automated amplification and detection of target nucleic acid sequences for use in clinical, industrial, and research settings.Class III·Terminated·Becton Dickinson & Co.·20130531
• Z-0976-2013 — BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR Cartridges, GeneOhm Sciences Canada, Inc. 2555 boul du Parc-Technologique, Quebec, Canada G1P 4S5***BD Max Group B Streptococcus (GBS) Assay is an in vitro diagnostic (IVD) test for detection of GBS DNA in Lim Broth cultures. The BD MAX" PCR Cartridge is a consumable required for the BD MAX" System.Class II·Terminated·Becton Dickinson & Co.·20121211
• Z-0701-2013 — Becton, Dickinson and Company, BD MAX (tm) (6 channel) Instruments, Catalog number 441916, clinical diagnostic instrument.Class II·Terminated·Becton Dickinson & Co.·20120918

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111860.