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K Number
K040619
Device Name
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
Manufacturer
TREK DIAGNOSTIC SYSTEMS, INC.
Date Cleared
2004-04-07

(29 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 Haemophilus/Streptococcus pneumoniae. This 510(k) is for the addition of Clindamycin in the dilution range of 0.016-8μg/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 Clindamycin is for: Streptococcus pneumoniae.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter for an in vitro diagnostic product, specifically a susceptibility plate for Clindamycin. It does not contain the detailed information necessary to answer your questions regarding acceptance criteria, study design, or performance metrics.

The provided text focuses on the regulatory approval process and states that the device is substantially equivalent to legally marketed predicate devices. It identifies the device, its intended use, and the regulatory classification. However, it does not include:

  • A table of acceptance criteria or reported device performance.
  • Details about sample sizes for test or training sets, or data provenance.
  • Information on expert ground truth establishment (number of experts, qualifications, adjudication method).
  • Whether MRMC or standalone performance studies were conducted, or any associated effect sizes.
  • The type of ground truth used.

Therefore,Based on the provided document, I cannot answer the questions about the acceptance criteria and study details.

§ 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).