# K032306: Versatrek

- Pathway: 510(k) (Special)
- Applicant: Trek Diagnostic Systems, Inc.
- Decided: Aug 22, 2003 after 28 days
- Product code: MDB (System, Blood Culturing)
- Device class: 1
- Regulation: 21 CFR 866.2560
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Jun 11, 2014 · Class II · Z-2057-2014: Bottles did not provide positive signals within the time frame of the quality control specification for one of two strains of Streptococcus pneumoniae.
- Jul 23, 2012 · Class III · Z-2323-2012: Review of instrument software databases and investigation of two customer reports determined that on rare occasions (less than 0.3%), following the removal of a positive signaling bottle from the Vers

## Indications for use
Blood Culture System (K921637/A): VersaTEK 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 PANTA 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 (K972772): Organism identification may be determined using nucleic acid probes (AccuProbe®). Mycobacterium 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.

Source page: https://510kreport.com/device/K032306
Methodology: https://510kreport.com/methodology