510(k) · Cleared
ClearedEsp Culture System II - Myco Susceptibility Testing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trek Diagnostic Systems, Inc. · MJA Susceptibility Test Powders, Antimycobacterial
Cleared on Jul 13, 1999 after a 719-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jul 13, 1999
- Review
- 719 days
- Class
- Class II
- Product code
- MJA
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All MJA devicesMJA 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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MJA
529in 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 | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 4 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 10 |
| 2023 | 0 | — | 0 | 43 |
| 2024 | 0 | — | 0 | 164 |
| 2025 | 0 | — | 0 | 529 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ESP Culture System II is an automated system for the detection of microbial growth from blood and other normally sterile body fluids, and for the detection of mycobacteria from various sources. The system may be used for the susceptibility testing of Mycobacterium tuberculosis with the drugs rifampin (1pg/ml), isoniazid (0.1 and 0.4pg/ml), and ethambutol (5 and 8pg/ml) The inoculum source for the susceptibility testing can originate from an ESP Myco seed bottle, or a McFarland No. 1 equivalent cell suspension created from colonies grown on an agar source.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972772 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972772: Esp Culture System II - Myco Susceptibility Testing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972772
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026