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K Number
K191914
Device Name
Thermo Scientific Sensititre ARIS HiQ System
Manufacturer
Thermo Fisher Scientific
Date Cleared
2019-11-06

(112 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 Sensititre ARIS HiQ System is designed for use with the Thermo Scientific Sensititre 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 Sensititre ARIS HiQ System is designed for use with the Thermo Scientific Sensititre 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 FDA clearance letter for the Thermo Scientific Sensititre ARIS HiQ System (K191914) does not contain the detailed information required to answer your questions regarding acceptance criteria and performance study specifics.

The document is a standard FDA 510(k) clearance letter, which primarily confirms that the device is substantially equivalent to a legally marketed predicate device. It briefly describes the device's intended use (automated plate management, incubator, OptiRead module for reading Sensititre susceptibility plates, generating MIC and interpreting breakpoint results for non-fastidious microorganisms) and regulatory classification.

It does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Details about sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods for test or training sets.
  3. Information on multi-reader multi-case (MRMC) studies or standalone algorithm performance.

To obtain this information, one would typically need to refer to:

  • The full 510(k) submission document itself, if it were publicly available with performance study details.
  • Performance study reports provided by the manufacturer to the FDA.
  • Clinical trial summaries or publications if the device involved such studies.

Therefore, based solely on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets those criteria. The information is simply not present in this FDA clearance letter.

§ 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).