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K Number
K040846
Device Name
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
Manufacturer
TREK DIAGNOSTIC SYSTEMS, INC.
Date Cleared
2004-04-26

(25 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 product for clinical susceptibility testing of H. influenzae/S. pneumoniae.

This 510(k) is for the addition of Ertapenem in the dilution range of 0.008-16ug/ml to the Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate for testing Haemophilus/Streptococcus pneumoniae isolates. The approved primary "Indications for Use" and clinical significance for Ertapenem is for: Streptococcus pneumoniae ( penicillin susceptible strains only) and Haemophilus influenzae (Beta-lactamase negative strains only). In vitro data. without clinical correlation is provided for: Streptococcus pneumoniae (penicillinintermediate strains only) and Haemophilus influenzae (Beta-lactamase positive strains)

Device Description

Not Found

AI/ML Overview

This document contains information related to the 510(k) premarket notification for the "Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plate For Ertapenem 0.008-16ug/ml". The provided text primarily focuses on the regulatory approval and indications for use, but it does not contain the detailed study information required to fully answer your request regarding acceptance criteria and performance data.

Specifically, the document lacks:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes used for test and training sets.
  • Data provenance (country, retrospective/prospective).
  • Number and qualifications of experts for ground truth.
  • Adjudication method.
  • MRMC comparative effectiveness study details.
  • Standalone algorithm performance.
  • Type of ground truth used (pathology, outcomes, etc.).
  • How ground truth for the training set was established.

The provided text only states that the device is an "in vitro diagnostic product for clinical susceptibility testing" and for the "addition of Ertapenem." It also mentions "In vitro data without clinical correlation is provided" for certain strains, which implies that some in vitro testing was done but the full details are not present in this excerpt.

To provide a complete answer with all the requested information, you would need to consult the full premarket notification submission (K040846) which would include the detailed study protocols, results, and acceptance criteria.

§ 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).