LogoFDA 510(k) Search
K Number
K150236
Device Name
Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Dalbavancin (0.0005 - 2ug/mL)
Manufacturer
THERMO FISHER SCIENTIFIC
Date Cleared
2015-07-27

(175 days)

Product Code
JWY,LRG,LTT,LTW
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

The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non fastidious isolates. This 510(ls) is for Dalbavancin in the dilution range of 0.0005-2 ug/ml for testing non-fastidious gram positive organisms on the Sensititre 18 - 24 hour MIC panel. The approved primary "Indications for Use" and clinical significance for non-fastidious Gram positive isolates: Staphylococcus aureus (including methicillin-resistant (MRSA) and methicillin susceptible (MSSA) isolates)

Device Description

Not Found

AI/ML Overview

This document, K150236, is a 510(k) premarket notification for the "Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Dalbavancin (0.0005-2 ug/ml)". It describes the device and its indications for use, but it does not contain the acceptance criteria or a study that proves the device meets those criteria, nor any of the other requested information.

The document is a letter from the FDA to Thermo Fisher Scientific, indicating that their device has been found substantially equivalent to legally marketed predicate devices. It then describes the regulatory framework and responsibilities. The "Indications for Use" section specifies what the device is intended for (in vitro diagnostic product for clinical susceptibility testing of non-fastidious isolates, specifically Dalbavancin for non-fastidious gram-positive organisms like Staphylococcus aureus).

Therefore, I cannot provide the requested information based on the input text. The text does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for a test set.
  3. Number or qualifications of experts for ground truth.
  4. Adjudication method.
  5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
  6. Results of a standalone performance study.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

§ 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).