510(k) · Cleared
ClearedMTS Omadacycline 0.002 - 32 ug/mL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Liofilchem s.r.l. · JWY Manual Antimicrobial Susceptibility Test Systems
Cleared on Mar 20, 2020 after a 56-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Mar 20, 2020
- Review
- 56 days
- Class
- Class II
- Product code
- JWY
- 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 JWY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JWY device
- #1 K260447 ETEST Gepotidacin (GEP) (0.016-256 µg/mL)score 12.7 · 6 generations · no Class I recall
- #2 Held for the reportin the report
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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 JWY devicesJWY Manual Antimicrobial Susceptibility Test Systems: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · JWY
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWY
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWY
31in 2022
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · JWY
1in 2024
MAUDE reports naming product code JWY, 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 | 6 | 85 | 1 | 1 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 4 | 73 | 0 | 0 |
| 2011 | 4 | 125 | 3 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 6 | 106 | 5 | 4 |
| 2015 | 9 | 90 | 6 (4) | 11 |
| 2016 | 4 | 88 | 0 | 20 |
| 2017 | 14 | 61 | 2 | 9 |
| 2018 | 12 | 51 | 0 | 13 |
| 2019 | 18 | 60 | 0 | 10 |
| 2020 | 5 | 66 | 0 | 20 |
| 2021 | 5 | 266 | 0 | 41 |
| 2022 | 0 | — | 31 (9) | 11 |
| 2023 | 7 | 85 | 0 | 9 |
| 2024 | 6 | 90 | 0 | 1 |
| 2025 | 14 | 106 | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The MTS (MIC Test Strip) Omadacycline 0.002 - 32 μg/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS™ consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in µg/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and…
Read the full statement (195 words)
The MTS (MIC Test Strip) Omadacycline 0.002 - 32 μg/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS™ consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in µg/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. The MTS Omadacycline at concentrations of 0.002 - 32 μg/mL should be interpreted at 16 - 20 hours (non-fastidious organisms) and 20 - 24 hours (fastidious organisms) of incubation.
Omadacycline has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved label:
Gram-Positive bacteria
Staphylococcus aureus
Staphylococcus lugdunensis
Enterococcus faecalis
Streptococcus pneumoniae
Streptococcus pyogenes
Streptococcus anginosus group (includes S. anginosus and S. constellatus)
Gram-Negative bacteria
Enterobacter cloacae
Klebsiella pneumoniae
Haemophilus influenzae
Haemophilus parainfluenzae
Omadacycline has been shown to be active in vitro only against the bacterial species listed below according to the FDA drug approved label:
Gram-Positive bacteria
Enterococcus faecium (vancomycin-susceptible and -resistant isolates)
Gram-Negative bacteria
Escherichia coli
Citrobacter freundii
Citrobacter koseri
Klebsiella aerogenes
Klebsiella oxytoca
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K200180 · printed Nov 4, 2026
Cite this page
510(k) Report. “K200180: MTS Omadacycline 0.002 - 32 ug/mL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K200180
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026