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K Number
K203741
Device Name
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml
Manufacturer
Thermo Fisher Scientific
Date Cleared
2021-12-20

(363 days)

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

Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a device called "Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol." It is a regulatory clearance for an Antimicrobial Susceptibility Test (AST) and does not pertain to an AI/ML medical device.

Therefore, the requested information regarding acceptance criteria and studies for an AI/ML device, such as:

  • A table of acceptance criteria and reported device performance (in the context of AI metrics).
  • Sample sizes for test and training sets, data provenance.
  • Number and qualifications of experts for ground truth establishment.
  • Adjudication methods.
  • Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
  • Standalone algorithm performance.
  • Types of ground truth (pathology, outcomes data, etc.).

cannot be extracted from the provided text.

The document primarily focuses on:

  • Regulatory clearance: Stating that the device is substantially equivalent to legally marketed predicate devices.
  • General controls: Listing the applicable regulations for the device (e.g., annual registration, listing, good manufacturing practice, labeling).
  • Contact information: For further inquiries regarding adverse events or regulatory information.
  • Indications for Use: (Though the section is blank in the provided snippet, indicating it would be described elsewhere).

In summary, the provided text does not contain the specific details about AI/ML device performance and validation studies that your request asks for.

§ 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).