(222 days)
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No
The description focuses on a miniaturized dilution technique and automated reading of growth, with no mention of AI/ML algorithms for interpretation or analysis.
No
This device is for in vitro diagnostic (IVD) use, specifically for antimicrobial susceptibility testing, which aids in determining the effectiveness of antimicrobial agents against certain microorganisms. It does not directly treat or prevent a disease or condition in a patient.
Yes
The device is designed for antimicrobial susceptibility testing of Streptococcus species, providing a quantitative test to aid in determining in vitro susceptibility to antimicrobial agents. This falls under the definition of a diagnostic device as it provides information for the diagnosis or treatment of a disease. It directly aids in determining the effectiveness of treatments (antibiotics) by identifying the susceptibility of microorganisms.
No
The device description clearly outlines physical components (VITEK 2 AST Cards, VITEK 2 System, VITEK 2 Compact) and a physical process (diluting bacterial isolates, filling and sealing cards, incubation). This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is "a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents." "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Device Description: The device description details how it tests bacterial isolates (outside the body) to determine their susceptibility to antibiotics. This process is performed in a laboratory setting.
- Performance Studies: The performance studies compare the device's performance to a "CLSI broth microdilution reference method," which is a standard laboratory technique for in vitro testing.
- Intended User/Care Setting: The intended user is a "laboratory aid," further indicating its use in a laboratory setting for diagnostic purposes.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VITEK® 2 AST Streptococcus Vancomycin is designed for antimicrobial susceptibility testing of Streptococcus species. VITEK® 2 AST Streptococcus Vancomycin 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 antimicrobial agents. Vancomycin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial.
Active in vitro and in clinical infections Viridans group streptococci
In vitro data are available, but their clinical significance is unknown Streptococcus agalactiae Streptococcus pyogenes
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 spp. and clinically significant yeast.
Product codes
LON
Device Description
VITEK® 2 AST Streptococcus Vancomycin 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 antimicrobial agents. The antimicrobial presented in VITEK 2 AST Cards is in concentrations equivalent by efficacy to standard method concentrations in mcg/m). The VITEK 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.
The bacterial isolate to be tested is diluted to a standardized concentration in 0.45 - 0 .50% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK 2 System automatically 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 18 hours). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic contained on the card.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
laboratory aid
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
An external evaluation was conducted with fresh clinical isolates and stock challenge strains. The external evaluations were designed to confirm the acceptability of VITEK 2 AST Streptococcus Vancomycin by comparing its performance with the CLSI broth microdilution reference method. The data is representative of performance on both the VITEK 2 and VITEK 2 Compact instrument platforms.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
VITEK 2 AST Streptococcus Vancomycin demonstrated substantially equivalent performance when compared with the CLSI broth microdilution reference method, as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA, Issued August 28, 2009. The Premarket Notification [510(k)] presents data in support of VITEK 2 AST Streptococcus Vancomvoin. An external evaluation was conducted with fresh clinical isolates and stock challence strains. The external evaluations were designed to confirm the acceptability of VITEK 2 AST Streptococcus Vancomycin by comparing its performance with the CLSI broth microdilution reference method. The data is representative of performance on both the VITEK 2 and VITEK 2 Compact instrument platforms. VITEK 2 AST Streptococcus Vancomycin demonstrated acceptable performance of 100% overall Category Agreement. Reproducibility and Quality Control demonstrated acceptable results using both the VITEK 2 Compact instrument systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
100% overall Category Agreement.
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.
(a)
Identification. A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.(b)
Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.”
0
K121/000
RIEUX
510(k) SUMMARY
VITEK® 2 AST Streptococcus Vancomycin
NOV 1 9 2012
510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Jocelyn Jennings |
| Senior Manager, Regulatory Affairs | |
| Phone Number: | 919-620-2894 |
| Fax Number: | 919-620-2548 |
| Date of Preparation: | April 5, 2012 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® 2 AST Streptococcus Vancomycin |
| ( |