510(k) · Cleared

Cleared

Versatrek Myco Pza Kit

K052323510(k) TraditionalCleared Jan 19, 2006147-day reviewClass II21 CFR 866.1640

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Trek Diagnostic Systems, Inc. · MJA Susceptibility Test Powders, Antimycobacterial

Cleared on Jan 19, 2006 as substantially equivalent to K895362 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1989) after a 147-day review. Its family tree reaches back 1 generation to 1989.

Decided: Jan 19, 2006
Review: 147 days
Class: Class II
Product code: MJA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K895362 (1989). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK895362 Bactec Pyrazinamide Susceptibility TestBd Becton Dickinson Vacutainer Systems Preanalytic · 1989
This deviceK052323 Versatrek Myco Pza KitTrek Diagnostic Systems, Inc. · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K895362	Bactec Pyrazinamide Susceptibility Test	Bd Becton Dickinson Vacutainer Systems Preanalytic	1989	—
0 (this device)	K052323	Versatrek Myco Pza Kit	Trek Diagnostic Systems, Inc.	2006	—

FIG. 1 — Lineage of K052323, 1989–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MJA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K895362	Bactec Pyrazinamide Susceptibility Test Summary page 4 …agreement of 88%. Conclusions: Data presented in this document demonstrates that the VersaTREK® MYCO PZA KIT is substantially equivalent to the BACTEC® 460 TB PZA Kit (k895362). 4…	Bd Becton Dickinson Vacutainer Systems Preanalytic	1989	—

Also cleared against K895362: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
1 other device also cites its predicate K895362.

How does its category compare?

All MJA devices

MJA Susceptibility Test Powders, Antimycobacterial: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MJA

FDA has decided no MJA device since 2007.

Median 510(k) review, days · MJA

Too few MJA 510(k)s in any year since 2007 to give a median.

Recalls per year · MJA

4in 2010

2007high 4 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MJA

529in 2025

2007high 529 (2025) · low 0 (2007)2025

MAUDE reports naming product code MJA, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	0
2010	—	4	0
2011	—	0	0
2012	—	0	0
2013	—	0	0
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	0	0
2019	—	0	0
2020	—	0	0
2021	—	0	5
2022	—	0	10
2023	—	0	43
2024	—	0	164
2025	—	0	529
2026	—	0	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052323 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052323: Versatrek Myco Pza Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052323

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026