510(k) · Cleared
ClearedLiofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 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 31, 2016 after a 99-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Mar 31, 2016
- Review
- 99 days
- Class
- Class II
- Product code
- JWY
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK153687 Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mLLiofilchem s.r.l. · 2016
- Descendant · cites it directly · 0 of its ownK260696 MTS Gepotidacin 0.016-256 µg/mLLiofilchem s.r.l. · 2026
- Descendant · cites it directly · 0 of its ownK252114 MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mLLiofilchem s.r.l. · 2025
- Descendant · cites it directly · 0 of its ownK251580 MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)Liofilchem s.r.l. · 2025
Most influential descendants
Showing 3 of 3 · See all- K260696MTS Gepotidacin 0.016-256 µg/mLLiofilchem s.r.l. · 2026 · cites it directly0descendants
- K252114MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mLLiofilchem s.r.l. · 2025 · cites it directly0descendants
- K251580MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)Liofilchem s.r.l. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K153687 | Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL | Liofilchem s.r.l. | 2016 | — |
| +1 | K260696 | MTS Gepotidacin 0.016-256 µg/mL | Liofilchem s.r.l. | 2026 | — |
| +1 | K252114 | MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL | Liofilchem s.r.l. | 2025 | — |
| +1 | K251580 | MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) | Liofilchem s.r.l. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
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
- #3 Held for the reportin 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? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K260696 (Liofilchem s.r.l., 2026) has gone furthest, with 0 descendants of its own.
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. 2016, 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 MIC Test Strip (MTS) is a quantitative method intended for the in vitro determination of antimicrobial suscpetibility of non-fastidious Gram negative and Gram positive acrobic bacteria (for example, Enterobacteriaceae, Pseudomonas, Enterococcus and Staphylococcus species) and fastidious bacteria (for example, anaerobes, Haemophilus and Streptococcus species and N. gonorrhoeae). MTS consists of specialized paper impregnated with a…
Read the full statement (152 words)
The Liofilchem MIC Test Strip (MTS) is a quantitative method intended for the in vitro determination of antimicrobial suscpetibility of non-fastidious Gram negative and Gram positive acrobic bacteria (for example, Enterobacteriaceae, Pseudomonas, Enterococcus and Staphylococcus species) and fastidious bacteria (for example, anaerobes, Haemophilus and Streptococcus species and N. gonorrhoeae). 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 ug/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.
The purpose of this 510(k) is specifically for the vancomycin MTS at concentrations of 0.016 - 256 ug/mL interpreted after 24 hours incubation.
The non-fastidious bacteria that have been shown to be active both clinically and in vitro against vancomycin according to the FDA label are:
Staphylococcus aureus and Staphylococcus epidermis (including methicillin resistant strains)
Enterococcus faecalis
Enterococcus faecium
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/K153687 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153687: Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153687
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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