MDB · System, Blood Culturing
Microbiology · 21 CFR 866.2560 · Class 1
Overview
| Product Code | MDB |
|---|---|
| Device Name | System, Blood Culturing |
| Regulation | 21 CFR 866.2560 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
| 3rd-Party Reviewable | Yes |
Identification
A microbial growth monitor is a device intended for medical purposes that measures the concentration of bacteria suspended in a liquid medium by measuring changes in light scattering properties, optical density, electrical impedance, or by making direct bacterial counts. The device aids in the diagnosis of disease caused by pathogenic microorganisms.
Classification Rationale
Class I. With the exception of automated blood culturing system devices that are used in testing for bacteria, fungi, and other microorganisms in blood and other normally sterile body fluids, this device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.
Recent Cleared Devices (20 of 67)
Showing 20 most recent of 67 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K222591 | BD BACTEC Plus Aerobic/F Culture Vials | Becton, Dickinson and Company | Mar 24, 2023 | SESE |
| K222559 | BD BACTEC Myco/F Lytic Culture Vials | Becton, Dickinson and Company | Mar 24, 2023 | SESE |
| K190405 | BACT/ALERT MP Reagent System | bioMerieux, Inc. | May 15, 2019 | SESE |
| K183166 | BacT/ALERT FA Plus; BacT/ALERT PF Plus | bioMerieux, Inc. | Feb 11, 2019 | SESE |
| K173873 | BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial | Becton, Dickinson and Company | Mar 16, 2018 | SESE |
| K161816 | BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO | bioMerieux, Inc. | Mar 28, 2017 | SESE |
| K161810 | BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial | Becton Dickinson | Feb 9, 2017 | SESE |
| K161306 | BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial | Becton Dickinson | Aug 8, 2016 | SESE |
| K151866 | BD BACTEC Peds Plus/F Culture Vials (plastic) | Becton, Dickinson and Company | Feb 25, 2016 | SESE |
| K141810 | BD BACTEC PLUS ANAEROBIC/F (PLASTIC) | Becton, Dickinson and Company | Dec 10, 2014 | SESE |
| K123903 | BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic) | Becton, Dickinson & CO | May 13, 2013 | SESE |
| K121455 | BACT/ALERT FN PLUS CULTURE BOTTLE | bioMerieux, Inc. | Jan 25, 2013 | SESE |
| K121446 | BACT/ALERT PF PLUS CULTURE BOTTLE | bioMerieux, Inc. | Jan 25, 2013 | SESE |
| K121461 | BACT/ALERT FA PLUS CULTURE BOTTLE | bioMerieux, Inc. | Jan 22, 2013 | SESE |
| K120994 | BD BACTEC Plus PRIME Aerobic/F Culture Vials | Becton, Dickinson and Company | Aug 7, 2012 | SESE |
| K113558 | BD BACTEC Plus Aerobic/F Culture Vials (plastic) | Becton, Dickinson and Company | Mar 16, 2012 | SESE |
| K083572 | BD BACTEC Plus Aerobic/F Culture Vials | Becton, Dickinson & CO | Dec 24, 2008 | SESE |
| K032306 | VERSATREK | Trek Diagnostic Systems, Inc. | Aug 22, 2003 | SESE |
| K031737 | BACT/ALERT MP CULTURE BOTTLES (PLASTIC) | bioMerieux, Inc. | Jul 14, 2003 | SESE |
| K021123 | BACT/ALERT SN CULTURE BOTTLE | bioMerieux, Inc. | Apr 26, 2002 | SESE |
Top Applicants
- Organon Teknika Corp. — 19 clearances
- bioMerieux, Inc. — 12 clearances
- Becton Dickinson Diagnostic Instrument Systems — 8 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 7 clearances
- Becton, Dickinson and Company — 7 clearances
