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K Number
K183140
Device Name
MTS Tetracycline 0.016 - 256 ug/mL
Manufacturer
Liofilchem s.r.l.
Date Cleared
2019-01-11

(59 days)

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

Not Found

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a device called "MTS Tetracycline 0.016 - 256 ug/mL" which is an antimicrobial susceptibility test powder. This document does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement as requested.

Therefore, I cannot provide the requested information based on the given input. The document is primarily a regulatory clearance letter and does not delve into the technical details of the validation study.

§ 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).