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K Number
K191918
Device Name
Thermo Scientific Sensititre ARIS HiQ System
Manufacturer
Thermo Fisher Scientific
Date Cleared
2019-11-06

(111 days)

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

The Thermo Scientific Sensititre ARIS HiQ System is part of the Sensititre AST system and is an automated plate management device containing an incubator and embedded OptiRead module. The Thermo Scientific Sensititire ARIS HiO System is designed for use with the Themo Scientific Sensitities SWIN Software System. The ARIS HiQ and the SWIN system work together to read Sensititre (18-24 hr) susceptibility plates, generating minimum inhibitory concentration (MIC) and interpreting breakpoint (BP) results for non-fastidious microorganisms.

Device Description

The Thermo Scientific Sensititre ARIS HiQ System is part of the Sensititre AST system and is an automated plate management device containing an incubator and embedded OptiRead module. The Thermo Scientific Sensititire ARIS HiO System is designed for use with the Themo Scientific Sensitities SWIN Software System. The ARIS HiQ and the SWIN system work together to read Sensititre (18-24 hr) susceptibility plates, generating minimum inhibitory concentration (MIC) and interpreting breakpoint (BP) results for non-fastidious microorganisms.

AI/ML Overview

The provided text is a 510(k) clearance letter for the Thermo Scientific Sensititre ARIS HiQ System. It describes the device's indications for use but does not contain any information about the acceptance criteria, study design, or performance metrics that would be required to answer the questions about how the device meets acceptance criteria.

Specifically, the document does not provide any data or details regarding:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes, data provenance, number of experts, adjudication methods for ground truth, or details about training and test sets.
  3. Whether MRMC or standalone studies were conducted, or details about ground truth establishment.

Therefore,Based on the provided document, I cannot answer the questions about the acceptance criteria and the study that proves the device meets those criteria.

§ 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).