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K Number
K242905
Device Name
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.12-32 ug/mL
Manufacturer
Thermofisher Scientific
Date Cleared
2025-02-10

(139 days)

Product Code
JWY,LRG,LTT
Regulation Number
866.1640
Type
Traditional
Panel
MI
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates.

This 510(k) is for linezolid in the dilution range of 0.12-32 ug/mL for testing fastidious isolates on The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System.

Linezolid has been shown to be active both clinically and in vitro against the following organisms according to the FDA drug label:

Streptococcus pneumoniae

Streptococcus spp. ß-hemolytic group (Streptococcus agalactiae, Streptococcus pyogenes)

Linezolid has been shown to be active in vitro only against the following organisms according to the FDA drug label:

Streptococcus spp. Viridans group

Device Description

Not Found

AI/ML Overview

The provided text does not contain detailed information about the acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a specific antimicrobial susceptibility test system (Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Linezolid).

While the letter confirms the device's substantial equivalence to a predicate device and outlines regulatory compliance, it does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Details about the sample size for test sets, data provenance, or the number and qualifications of experts for ground truth.
  3. Information on adjudication methods.
  4. Whether a multi-reader multi-case (MRMC) comparative effectiveness study was performed or any effect size of human reader improvement with AI assistance.
  5. Whether a standalone algorithm-only performance study was conducted.
  6. The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
  7. The sample size for the training set or how its ground truth was established.

This document is primarily an FDA clearance letter, not a study report or clinical trial summary. To get the requested information, one would typically need to refer to the 510(k) submission itself or related clinical study reports, which are not included in the provided text.

§ 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).