# K052323: Versatrek Myco Pza Kit

- Pathway: 510(k) (Traditional)
- Applicant: Trek Diagnostic Systems, Inc.
- Decided: Jan 19, 2006 after 147 days
- Product code: MJA (Susceptibility Test Powders, Antimycobacterial)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K895362 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895362: Bactec Pyrazinamide Susceptibility Test, Bd Becton Dickinson Vacutainer Systems Preanalytic (1989) Summary page 4.

## Indications for use
The VersaTREK MYCO PZA KIT is a rapid qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture, to pyrazinamide (PZA). The VersaTREK MYCO PZA KIT is used with the ESP Culture System IIor with the VersaTREK Microbial Detection System. The VersaTREK MYCO PZA KIT final test concentration is 300 pg/ml for PZA.

Source page: https://510kreport.com/device/K052323
Methodology: https://510kreport.com/methodology