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K Number
K983571
Device Name
SYSTEM U3 FOR TETRACYCLINE
Manufacturer
AB BIODISK
Date Cleared
1998-12-30

(78 days)

Product Code
JWY
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

For in vitro diagnostic use:

System U3™ is a qualitative technique for antimicrobial susceptibility testing of nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species. The system comprises an antibiotic gradient with MIC break-point concentrations and is used to determine the susceptibility categories of microorganisms to different antimicrobial agents, as tested on agar media using overnight incubation.

This 510(k) application is for System U3/Tetracycline susceptibility testing based on the MIC breakpoints of Susceptible ≤ 4 µg/ml, Intermediate 8 µg/ml and Resistant ≥ 16 µg/ml for use with non-fastidious Gram negative and Gram positive aerobic bacteria.

Device Description

System U3™ is a qualitative technique for antimicrobial susceptibility testing of nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species. The system comprises an antibiotic gradient with MIC break-point concentrations and is used to determine the susceptibility categories of microorganisms to different antimicrobial agents, as tested on agar media using overnight incubation.

AI/ML Overview

I am sorry, but the provided text does not contain the acceptance criteria or a study proving that the device meets acceptance criteria. The document is an FDA 510(k) clearance letter for the "System U3™ for Tetracycline," which confirms its substantial equivalence to a legally marketed predicate device.

It includes:

  • The device name and its intended use (in vitro diagnostic for antimicrobial susceptibility testing of non-fastidious Gram negative and Gram positive aerobic bacteria).
  • The MIC breakpoints for Tetracycline (Susceptible ≤ 4 µg/ml, Intermediate 8 µg/ml, and Resistant ≥ 16 µg/ml).

However, it does not provide:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for a test set.
  3. Details about experts used for ground truth or adjudication methods.
  4. Information about MRMC comparative effectiveness studies.
  5. Details about standalone algorithm performance.
  6. The type of ground truth used in a study.
  7. Sample size or ground truth establishment for a training set.

To answer your request, I would need a different document that details the device's validation studies, performance data, and the specific acceptance criteria used for its clearance.

§ 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).