JTA · Monitor, Microbial Growth
Microbiology · 21 CFR 866.2560 · Class 1
Overview
| Product Code | JTA |
|---|---|
| Device Name | Monitor, Microbial Growth |
| Regulation | 21 CFR 866.2560 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
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 (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K954923 | BACTEC FUNGAL MEDIUM | Becton Dickinson Diagnostic Instrument Systems | Nov 21, 1996 | SESE |
| K910835 | BACTEC NR-860 | Bd Becton Dickinson Vacutainer Systems Preanalytic | Mar 11, 1991 | SESE |
| K865021 | BACTEC(R) NR-660 HIGH PERFORMANCE SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | Feb 6, 1987 | SESE |
| K853011 | BACTEC NR-730 BACTERIAL DETECTION SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jul 30, 1985 | SESE |
| K842874 | RADIOMETRIC BLOOD CULTURE VIALS, AEROBE | American Micro Scan | Sep 12, 1984 | SESE |
| K842279 | BECTEC NR-660 BACTERIAL DETECT SYS | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jul 20, 1984 | SESE |
| K834264 | REVERSE-FLOW SYSTEM | Applied Polytechnology, Inc. | Jan 13, 1984 | SESE |
| K833917 | BAC-T-SCREEN | Marion Laboratories, Inc. | Jan 13, 1984 | SESE |
| K810042 | BACTEC BACTERIAL DETECTION SYSTEM: #5 | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jan 28, 1981 | SESE |
| K792575 | BACTEC BACTERIAL DETECTION SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | Dec 27, 1979 | SESE |
| K790297 | DETECTION SYSTEM, MS-2 ELECTROCHEMICAL | Abbott Laboratories | Apr 26, 1979 | SESE |
Top Applicants
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 6 clearances
- Abbott Laboratories — 1 clearance
- American Micro Scan — 1 clearance
- Applied Polytechnology, Inc. — 1 clearance
- Becton Dickinson Diagnostic Instrument Systems — 1 clearance
