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K Number
K020859
Device Name
CEFOTAXIME
Manufacturer
TREK DIAGNOSTIC SYSTEMS, INC.
Date Cleared
2002-05-15

(58 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

The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic device for determining quantitative minimum inhibitory concentrations (MIC) of Streptococcus pneumoniae and Haemophilus influenzae. This 510(k) is for the addition of Cefotaxime in the dilution range of 0.016 - 4 µgml to the Sensititre Haemophilus/Streptococcus pneumoniae MIC panel for testing Streptococcus pneumoniae and Haemophilus influenzae isolates. The "Indications for Use" and clinical significance of Cefotaxime is for: Haemophilus Influenzae

Device Description

Not Found

AI/ML Overview

The provided text does not contain information regarding acceptance criteria or a study proving that a device meets such criteria. Instead, it is an FDA 510(k) clearance letter for the Sensititre™ Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates, Cefotaxime for Haemophilus influenzae.

The document indicates that the device has been found substantially equivalent to legally marketed predicate devices, allowing it to be marketed. However, it does not include details on:

  1. Acceptance criteria table or reported device performance.
  2. Sample size for the test set or data provenance.
  3. Number or qualifications of experts for ground truth.
  4. Adjudication method.
  5. MRMC comparative effectiveness study or effect size.
  6. Standalone (algorithm only) performance.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

The document specifically mentions the "Indications For Use" for the device, stating that it is an "in vitro diagnostic product for determining quantitative susceptibility of Streptococcus pneumoniae and Haemophilus influenzae isolates." It also clarifies that the 510(k) is for the addition of Cefotaxime in a specific dilution range to the existing MIC panel for testing these isolates.

§ 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).