Device |
gas chromatography, bacillus anthracis membrane fatty acids |
Regulation Description |
In vitro diagnostic device for Bacillus spp. detection. |
Definition |
Aid in the identification of Bacillus Anthracis |
Physical State |
25 x 0.2 mm capillary column (0.33-film thickness of 5% diphenyl-95%-dimethyl siloxane), an oven with 170-270aC increase range during analysis, an autoinjector, MIDI Sherlock Microbial Identification System software that includes the BTR library, and a calibration standard |
Technical Method |
Gas chromatography and pattern recognition |
Target Area |
Trypticase soy agar (with 5% sheep blood) bacterial cultures of any specimen type from the human body |
Regulation Medical Specialty |
Microbiology |
Review Panel |
Microbiology |
Product Code | NWZ |
Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Microbiology Devices
(DMD)
|
Submission Type |
510(k)
|
Regulation Number |
866.3045
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |