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K Number
K013368
Device Name
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
Manufacturer
TREK DIAGNOSTIC SYSTEMS, INC.
Date Cleared
2001-11-20

(40 days)

Product Code
LTT,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 Streptococcus pneumoniae and Haemophilus influenzae. This 510(k) is for the addition of Amoxicillin/Clavulanic Acid in the dilution range of 0.016/0.008 - 16/8 µg/ml to the Sensititre Haemonhilus/Streptococcus pneumoniae MIC panel for testing Streptococcus pneumoniae and Haemophilus influenzae isolates. The "Indications for Use" and clinical significance of Amoricillin/Clavulanic Acid is for: Streptococcus pneumoniae

Device Description

Sensititre™ Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates, Amoxicillin/Clavulanic Acid

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a diagnostic device. It does not contain the detailed study information or acceptance criteria requested. The letter confirms that the device, "Sensititre™ Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates, Amoxicillin/Clavulanic Acid," has been found substantially equivalent to a predicate device, allowing it to be marketed.

Therefore, I cannot extract the specific information about:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes used for the test set or data provenance.
  • Number of experts used to establish ground truth or their qualifications.
  • Adjudication method.
  • MRMC comparative effectiveness study results.
  • Standalone performance.
  • Type of ground truth used.
  • Sample size for the training set.
  • How ground truth for the training set was established.

This document is a regulatory approval, not a scientific study report. To get the requested details, one would typically need access to the full 510(k) submission or a corresponding scientific publication from the device manufacturer.

§ 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).