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K Number
K110583
Device Name
SENSITITRE OPTIREAD
Manufacturer
TREK DIAGNOSTIC SYSTEMS, LTD.
Date Cleared
2011-09-22

(205 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 Sensititre® OptiRead™ is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® OptiRead™ is a fluorescence based detection instrument used to read Sensititre® MIC or BP Susceptibility plates.

The Sensititre MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious Gram negative organisms.

The Sensititre OptiRead is used to read fluorescence values from the Sensititre MIC or BP Susceptibility Test System for non-fastidious Gram negative organisms. The plate reading on the OptiRead is initiated via SWIN software and the fluorescence values from the OptiRead are then transferred back to the SWIN software where the results are generated.

Device Description

The Sensititre® OptiRead™ is a fluorescence based detection instrument used to read Sensititre® MIC or BP Susceptibility plates.

AI/ML Overview

This document is a 510(k) clearance letter for the Sensititre® OptiRead™, an antimicrobial susceptibility test powder reader. It does not contain the detailed study information required to answer your questions. The letter simply states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide:

  1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
  2. Sample sizes used for the test set and the data provenance: This information is not present.
  3. Number of experts used to establish the ground truth for the test set and their qualifications: This information is not present.
  4. Adjudication method: This information is not present.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: This information is not present.
  6. If a standalone performance study was done: This information is not present.
  7. The type of ground truth used: This information is not present.
  8. The sample size for the training set: This information is not present.
  9. How the ground truth for the training set was established: This information is not present.

The document focuses on the regulatory clearance and the device's indications for use, not the specifics of its validation studies.

§ 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).