510(k) · Cleared
ClearedMTS Eravacycline 0.002 - 32 µg/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 Nov 2, 2018 after a 46-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Nov 2, 2018
- Review
- 46 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. 2018, 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 Liofilchem® MTS™ (MIC Test Strip) Eravacycline 0.002-32 pg/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 pg/mL of antimicrobial agents against bacteria as tested on agar media using overnight…
Read the full statement (172 words)
The Liofilchem® MTS™ (MIC Test Strip) Eravacycline 0.002-32 pg/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 pg/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.
The MTS™ Eravacycline at concentrations of 0.002 - 32 pg/mL should be interpreted at 16-20 hours of incubation.
MTS™ Eravacycline can be used to determine the MIC of eravacycline against the following bacteria.
Eravacycline 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
Enterococcus faecalis
Enterococcus faecium
Staphylococcus aureus
Gram-negative bacteria
Citrobacter freundii
Enterobacter cloacae
Escherichia coli
Klebsiella oxytoca
Klebsiella pneumoniae
Eravacycline has been shown to be active in vitro only against the non-fastidious bacteria listed below according to the FDA drug approved label:
Citrobacter koseri
Klebsiella (Enterobacter) aerogenes
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/K182557 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182557: MTS Eravacycline 0.002 - 32 µg/mL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182557
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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