(28 days)
Blood Culture System (K921637/A): VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile body fluids.
Myco Detection (K972756): VersaTREK Myco, with VersaTrek Myco GS, and Either VersaTREK as or PVNA added is a selective growth medium for use with either VersaTREK or ESP II Culture system II for the culture recovery of mycobacteria from sterile body specimens and from digested-decontaminated clinical specimens.
Myco modification-Organism Identification (KK972772): Organism identification may be determined using nucleic acid probes (AccuProbe®) .
Mvcobacterium tuberculosis susceptibility testing (K972772): The VersaTREK Myco Susceptibility Kit is intended for qualitative in vitro susceptibility testing of isolated colonies of Mycobacterium tuberculosis with Rifampin, Ethambutol, and Isoniazid on the VersaTREK instrument. Appropriate inoculum sources are prepared from growth on solid agar, such as Middlebrook 7H10 or Lowenstein-Jensen slants, or Middlebrook 7H9 broth.
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I apologize, but the provided text from the FDA 510(k) clearance letter for the VERSATREK device does not contain the specific information you are requesting about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.
The letter primarily focuses on:
- Substantial Equivalence Determination: Stating that the VERSATREK is substantially equivalent to legally marketed predicate devices.
- Regulatory Classification: Identifying the device as Class I and its product code (MDB).
- General Controls: Listing the general regulatory requirements for the device.
- Indications for Use: Detailing the intended purposes of the VERSATREK instrument and its associated components (Blood Culture System, Myco Detection, Myco modification-Organism Identification, Mycobacterium tuberculosis susceptibility testing).
To answer your questions, I would need to analyze a different document, such as the full 510(k) submission, the study report, or a publication detailing the device's validation. This clearance letter is a regulatory approval, not a scientific study report.
§ 866.2560 Microbial growth monitor.
(a)
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.(b)
Classification. 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.