(116 days)
VITEK® 2 Yeast Caspofungin is designed for antifungal susceptibility testing of Candida species. VITEK 2 Yeast Caspofungin is a quantitative test intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antifungal agents. Caspofungin has been shown to be active both in vitro and in clinical infections against most strains of the following microorganisms according to the FDA label for the antifungal.
Candida albicans Candida glabrata Candida guilliermondii
Candida krusei Candida parapsilosis Candida tropicalis
. The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 System for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, S. pneumoniae and clinically significant yeast.
VITEK® 2 Yeast Caspofungin is designed for antifungal susceptibility testing of Candida species. VITEK® 2 Yeast Caspofungin is a quantitative test intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antifungal agents. Caspofungin has been shown to be active against most strains of the following microorganisms listed below according to the FDA label for the antifungal.
Candida albicans Candida krusei Candida parapsilosis Candida tropicalis Candida lusitaniae Candida quilliermondii
The antifungal presented in VITEK® 2 AST Cards is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml. The VITEK 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.
The isolate to be tested is diluted to a standardized concentration in 0.45% saline before being used to TThe ISolate to be tested is different is a carded be normatically fills, seals and places the card into the incubator/reader. The VITEK® 2 Compact has a manual filling and sealing operation. The VITEK® 2 monitors the growth of each well in the card over a defined period of time (up to 36 hours for yeast). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antifungal contained on the card.
Here's an analysis of the acceptance criteria and study details for the VITEK® 2 Yeast Caspofungin device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document refers to the "FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA. Issued Mar. 5, 2007" as defining the acceptance criteria for substantial equivalence. While the document doesn't explicitly list numerical acceptance thresholds within this text, it does state the device's performance results in relation to those implied criteria.
| Metric | Acceptance Criteria (Implied by FDA Guidance) | Reported Device Performance |
|---|---|---|
| Overall Essential Agreement | (Defined by FDA Guidance, not specified here) | 99.5% |
| Overall Category Agreement | (Defined by FDA Guidance, not specified here) | 99.8% |
| Reproducibility | Acceptable | Acceptable |
| Quality Control | Acceptable | Acceptable |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document mentions "fresh and stock clinical isolates, as well as a set of challenge strains." However, a specific numerical sample size for the test set is not provided in the document.
- Data Provenance: The document does not specify the country of origin for the data. The data is described as an "external evaluation" using "fresh and stock clinical isolates" and "challenge strains," implying real-world samples and engineered samples, but does not explicitly state if it was retrospective or prospective. Given the mention of "fresh clinical isolates," it suggests a prospective component.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The document does not provide details on the number of experts or their qualifications used to establish the ground truth for the test set. It refers to the "CLSI reference method" as the comparator for ground truth, which is a standardized laboratory method, not an expert panel.
4. Adjudication Method for the Test Set:
No adjudication method for a test set is described, as the ground truth relies on a standardized reference method (CLSI), not expert consensus that typically requires adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is mentioned, nor is there any discussion of human readers improving with AI assistance. The device is an automated in vitro diagnostic intended to determine antimicrobial susceptibility, not to assist human interpretation of images or other subjective data.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Yes, the study described is a standalone performance study. The VITEK® 2 Yeast Caspofungin system is an automated device designed to produce quantitative and interpretive results (MIC values and interpretive categories) without direct human intervention in the result generation process once the sample is loaded. The performance metrics (Essential Agreement and Category Agreement) are direct comparisons between the device's output and the CLSI reference method.
7. Type of Ground Truth Used:
The ground truth used for the test set was the CLSI (Clinical and Laboratory Standards Institute) reference method. Specifically, it refers to the CLSI reference method incubated at 24 hours. The CLSI method for antimicrobial susceptibility testing is a highly standardized, laboratory-based method considered the gold standard for determining minimum inhibitory concentrations (MICs).
8. Sample Size for the Training Set:
The document does not provide any information regarding the sample size used for the training set.
9. How the Ground Truth for the Training Set Was Established:
The document does not provide information on how the ground truth for the training set was established. Given the nature of the device (an AST system), it's likely that extensive data from CLSI reference methods would have been used during development and internal validation, but this is not explicitly stated as for a "training set" in the context of this 510(k) summary.
§ 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).