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K Number
K243202
Device Name
MTS Ceftobiprole 0.002-32 µg/mL
Manufacturer
Liofilchem s. r. l.
Date Cleared
2025-01-30

(121 days)

Product Code
JWY
Regulation Number
866.1640
Type
Traditional
Panel
MI
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The MTS (MIC Test Strip) Ceftobiprole (BPR) 0.002-32 ug/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS consists of specialized paper impregnated with a predefined 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. MTS Ceftobiprole at concentrations of 0.002-32 µg/mL should be interpreted at 16-20 hours of incubation.

MTS BPR can be used to determine the MC of ceftobioprole against the following microorganisms for which ceftobiprole has been shown to be active both clinically and/or in vitro according to the FDA drug approved label:

Escherichia coli Klebsiella pneumoniae Staphylococcus aureus (includes methicillin resistant isolates)

Device Description

MTS consists of specialized paper impregnated with a predefined 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.

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (MTS Ceftobiprole 0.002-32 µg/mL antimicrobial susceptibility test). This document is an administrative letter regarding the clearance of the device and does not contain the detailed information about the acceptance criteria or the specific study that proves the device meets those criteria, as typically found in a clinical study report or a premarket notification summary.

Therefore, I cannot extract the information required to populate the table and answer the questions regarding acceptance criteria and study details.

§ 866.1640 Antimicrobial susceptibility test powder.

(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).