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K Number
K182797
Device Name
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008- 16 µg/mL
Manufacturer
Thermo Fisher Scientific
Date Cleared
2018-11-30

(60 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 Eravacycline in the dilution range of 0.008 - 16 ug/mL

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text only contains an FDA 510(k) clearance letter for a medical device (Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Eravacycline). It does not contain any information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information, which includes:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes for test set and data provenance.
  3. Number of experts and their qualifications for ground truth establishment.
  4. Adjudication method for the test set.
  5. MRMC study results (effect size of human reader improvement with AI).
  6. Standalone performance results.
  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).