VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACIN
Device Facts
| Record ID | K132573 |
|---|---|
| Device Name | VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACIN |
| Applicant | bioMerieux, Inc. |
| Product Code | LON · Microbiology |
| Decision Date | Sep 13, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.1645 |
| Device Class | Class 2 |
Intended Use
VITEK 2 Strentococcus Moxifloxacin is designed for antimicrobial susceptibility testing of Streptococcus species and is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 Streptococcus Moxifloxacin is a quantitative test. Moxifloxacin 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 Streptococcus anginosus Streptococcus constellatus Streptococcus pneumoniae (including multi-drug resistant isolates [MDRSP]*) Streptococcus pyogenes *MDRSP. Multi-drug resistant Streptococcus pneumoniae includes isolates previously known as PRSP (Penicillin resistant S. pneumoniae), and are isolates resistant to two or more of the following antibiotics: penicillin (MIC) ≥2 mcg/mL), 2nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole. The following in vitro data are available, but their clinical significance is unknown. Gram-positive bacteria Streptococcus agalactiae Streptococcus viridans group The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems 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.
Device Story
VITEK 2 AST-ST Moxifloxacin is a quantitative, automated antimicrobial susceptibility test (AST) card for use with VITEK 2 and VITEK 2 Compact systems. Input: isolated bacterial colonies diluted in saline. Operation: card contains 64 wells with premeasured antibiotic concentrations (0.5, 1, 4, 8 µg/mL) and culture media; system automatically fills, seals, and incubates cards. Detection: optical scanner measures light attenuation (growth) over time. Output: MIC value and interpretive category (S, I, R). Used in clinical microbiology laboratories to assist clinicians in selecting appropriate antibiotic therapy for Streptococcus infections. Benefits: provides standardized, automated, rapid susceptibility results compared to manual dilution methods.
Clinical Evidence
Performance established via clinical study of 941 viable clinical isolates and 159 challenge isolates. Combined data showed 93.5% Essential Agreement (EA) and 99.5% Category Agreement (CA) compared to CLSI broth microdilution reference method. Minor categorical errors observed (0.5%); no very major or major errors reported. Reproducibility >95% across three sites.
Technological Characteristics
Miniaturized, automated broth microdilution format. 64-well card containing culture media and antibiotic. Optical scanner (visible light) for growth detection via light transmittance. Automated incubation (4-24 hours). Connectivity: VITEK 2/Compact system. Software-based growth monitoring and MIC calculation.
Indications for Use
Indicated for antimicrobial susceptibility testing of Streptococcus species (including S. anginosus, S. constellatus, S. pneumoniae [including MDRSP], S. pyogenes, S. agalactiae, and viridans group streptococci) using isolated colonies. For prescription use in laboratory settings.
Regulatory Classification
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.
Special Controls
*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.”
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