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The Liofilchem® MTST™ (MIC Test Strip) Eravacycline 0.002-32 µg/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTST™ 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 MTST™ Eravacycline at concentrations of 0.002 - 32 µg/mL should be interpreted at 16-20 hours of incubation.
MTST™ 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

MTST™ 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 provided text describes the 510(k) premarket notification for the Liofilchem® MTST™ (MIC Test Strip) Eravacycline 0.002-32 µg/mL. This device is an antimicrobial susceptibility test (AST) that determines the minimum inhibitory concentration (MIC) of eravacycline against certain bacteria.

However, the provided document is a clearance letter and an indications for use statement. It does not contain the detailed study results, acceptance criteria, or the methodology of the studies used to prove the device meets its performance requirements. Typically, this information would be found in the 510(k) submission itself or in a summary document (e.g., a 510(k) Summary or 510(k) Review Memorandum) which is often publicly available from the FDA.

Therefore, based solely on the provided text, I cannot fulfil the request to describe the acceptance criteria and the study that proves the device meets them, as the relevant information is absent. I can only infer what kind of study was likely performed based on the device type.

What is present in the document:

• Device: Liofilchem® MTST™ (MIC Test Strip) Eravacycline 0.002-32 µg/mL
• Regulation Number/Name: 21 CFR 866.1640, Antimicrobial susceptibility test powder
• Intended Use: Quantitative method for in vitro determination of antimicrobial susceptibility of bacteria, specifically for determining MIC of eravacycline against listed Gram-positive and Gram-negative bacteria.
• Performance Claim: The device measures MICs against specific bacteria.

What is NOT present in the document (and thus cannot be answered):

• A table of acceptance criteria and reported device performance.
• Sample sizes used for the test set or training set.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts, their qualifications, or adjudication methods for ground truth.
• Information on Multi Reader Multi Case (MRMC) comparative effectiveness studies or effect sizes.
• Stand-alone (algorithm-only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) or how it was established for training/test sets.

To provide the requested information, a different document detailing the device's validation studies would be needed.

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