← Product Code [LON](/productcode/LON) · K031865 # VITEK 2 GRAM POSITIVE MOXIFLOXACIN FOR STREPOCOCCUS PNEUMONIAE (K031865) _bioMerieux, Inc. · LON · Aug 13, 2003 · Microbiology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K031865 ## Device Facts - **Applicant:** bioMerieux, Inc. - **Product Code:** [LON](/productcode/LON.md) - **Decision Date:** Aug 13, 2003 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.1645 - **Device Class:** Class 2 - **Review Panel:** Microbiology ## Indications for Use VITEK® 2 Gram Positive Moxifloxacin for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Streptococcus pneumoniae. It is intended for use with the VITEK® 2 System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. ## Device Story VITEK® 2 system performs automated antimicrobial susceptibility testing (AST) on isolated S. pneumoniae colonies. System uses test cards containing 64 microwells with premeasured antibiotic concentrations and culture medium. Organism suspension prepared in saline, standardized via DensiChek, and loaded into VITEK® 2 instrument. Instrument automatically dilutes suspension, fills cards via vacuum, seals them, and transfers to incubator carousel. Optical scanning occurs every 15 minutes at 35.5°C to measure growth via light transmittance. Discriminate analysis algorithm processes growth characteristics to calculate MIC results. Results reported as category interpretation (S, I, R) alongside MIC. Used in clinical laboratories to guide antimicrobial therapy decisions. ## Clinical Evidence Bench testing only. Method comparison study performed at three sites using 517 clinical and challenge S. pneumoniae isolates. Compared against broth dilution reference method (5% lysed horse blood). Combined results showed 99.6% Essential Agreement (EA) and 95% Category Agreement (CA). No very major or major discrepancies observed; 26 minor discrepancies reported. Reproducibility >95% across sites using both auto-dilution and manual inoculation methods. ## Technological Characteristics Miniaturized doubling dilution technique for MIC determination. Automated incubation and optical growth monitoring. System uses 0.45% saline for sample preparation. Software-based analysis of growth kinetics to determine MIC and interpretive categories. ## Regulatory 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.” ## Predicate Devices - VITEK®2 Streptococcus pneumoniae Susceptibility Test for Ceftriaxone (N50510/S135) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY DEVICE ONLY TEMPLATE A. 510(k) Number: k031865 B. Analyte: Moxifloxacin at equivalency concentrations of 0.25 - 2 ug/ml AST C. Type of Test: Quantitative growth based detection algorithm using optics light detection D. Applicant: bioMerieux, Inc. E. Proprietary and Established Names: VITEK®2 Gram Positive Moxifloxacin for Streptococcus pneumoniae F. Regulatory Information: 1. Regulation section: 866.1645 Short-Term Antimicrobial Susceptibility Test System 2. Classification: II 3. Product Code: LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation 4. Panel: 83 Microbiology G. Intended Use: 1. Intended use(s): 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 most clinically significant aerobic gram-negative susceptibility testing of isolated colonies for most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae. 2. Indication(s) for use: VITEK®2 Gram Positive Moxifloxacin for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Streptococcus pneumoniae. It is intended for use with the VITEK®2 System as a laboratory aid in the determination of in vitro susceptibility antimicrobial agents. 3. Special condition for use statement(s): The testing of moxifloxacin at equivalency concentration of 0.25, 1 and 2 ug/ml will provide MIC results in the range of 0.25-4 ug/ml. 4. Special instrument Requirements: Not applicable H. Device Description: Each VITEK® 2 test card contains 64 microwells. A control well, that contains only microbiological culture medium is resident on all cards, with the remaining wells containing premeasured amounts of a specific antibiotic combined with culture {1} Page 2 of 5 medium. A suspension of organism is made in 0.45-0.5% sterile saline from a pure culture and standardized to a McFarland 0.5 standard using the DensiChek. The desired card (s) are placed in the cassette along with an empty tube for the susceptibility card. The cassette is placed into the VITEK® 2 instrument where a susceptibility test will be automatically diluted from the ID suspension by the VITEK® 2. (275 microliter/2.5ml for manual inoculations and 235 microliter/2.5 ml saline for gram positive cocci.). The cards are then automatically vacuum filled; the tubes are cut and the cards sealed prior to proceeding to the Incubator Loading Station. Cards are then transferred from the cassette into the carousel for incubation (35.5°C) and optical scanning during testing. Readings are performed every 15 minutes. There is also a manual pre-diluted inoculum method that may be used instead of the instrument auto-dilution method. I. Substantial Equivalence Information: 1. Predicate device name(s): VITEK®2 Streptococcus pneumoniae Susceptibility Test for Ceftriaxone. 2. Predicate K number(s): N50510/S135 3. Comparison with predicate: | Similarities | | | | --- | --- | --- | | Item | Device | Predicate | | Intended Use | same | same | | Test organism | Colonies of Streptococcus pneumoniae | Colonies of Streptococcus pneumoniae | | Test Card | VITEK® 2 card format with base broth | same | | Instrument | VITEK® 2 System | VITEK® 2 System | | Differences | | | | Item | Device | Predicate | | Indications | Concentrations of Moxifloxacin | Concentrations of Ceftriaxone | | Reading algorithm | Unique for moxifloxacin | Unique for Ceftriaxone | J. Standard/Guidance Document Referenced (if applicable): Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA”; NCCLS M7 (M100-S13) “Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard” K. Test Principle: Optics systems use visible light to directly measure organism growth. These transmittance optics are based on an initial light reading of a well before significant growth has begun. Periodic light transmittance samplings of the same well measure organism growth by how much light is prevented from going through the well. An interpretive call is made between 4 and 16 hours with the majority of the S. pneumoniae between 5 and nine hours. The VITEK® Susceptibility Card test is based on the microdilution minimum inhibitory concentration technique with concentrations {2} Page 3 of 5 equivalent to standard method concentrations. Several parameters based on the growth characteristics observed are used to provide appropriate input for the MIC calculations. Discriminate analysis is used to develop the algorithm that determines the susceptibility result for all antimicrobials on the VITEK® 2 system. The MIC result must be linked to an organism identification in order to determine a category interpretation. A category interpretation will be reported along with an MIC. ## L. Performance Characteristics (if/when applicable): ### 1. Analytical performance: a. Precision/Reproducibility: Twelve S. pneumoniae with on-scale results were tested at four different sites for an overall reproducibility of >95% for between site reproducibility. An additional site tested the same set three times for a within site reproducibility of >95%. This testing was performed using both the manual dilution of the inoculum and also the automatic dilution method. b. Linearity/assay reportable range: Not applicable c. Traceability (controls, calibrators, or method): | ORGANISM | conc | Reference | Auto-dilution | Manual dilution | | --- | --- | --- | --- | --- | | | | | | | | S. pneumoniae ATCC 49619 Range 0.06-0.25 ug/ml | ≤ 0.06 | 65 | | | | | 0.125 | 93 | 80(≤ 0.25) | 78(≤ 0.25) | | | 0.25 | | | | | | 0.5 | | | | Quality Control was performed during the studies using both the auto-dilution and the manual method of diluting the organisms. The results were out of range for the panel for all results as would be expected with the range that is expected for this quality control organism. Inoculum density control: The DensiChek instrument was calibrated weekly during the study with acceptable results at all times. Internal testing to verify the performance of the DensiChek was also provided. d. Detection limit: Not applicable e. Analytical specificity: Not applicable f. Assay cut-off: Not applicable ### 2. Comparison studies: a. Method comparison with predicate device: The reference method used for comparison was the broth dilution using 5% lysed horse blood. Studies were performed at three sites on clinical isolates of S. {3} Page 4 of 5 pneumoniae using the auto-dilution feature of the VITEK® 2® instrument. A set of challenge isolates was also tested using the auto-dilution method of inoculation. There was a 1% "no growth" rate on the VITEK® 2® test panel for the challenge and the clinical isolates combined. The performance of these isolates is presented in the following table. | | total | EA | %EA | Total evaluable | EA of evaluable | %EA | CA | %CA | #R | min | maj | vmj | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Clinical | 464 | 462 | 99.6 | 35 | 34 | 97.1 | 438 | 94.4 | 25 | 26 | 0 | 0 | | Challenge | 53 | 53 | 100 | 1 | 1 | 100 | 53 | 100 | 0 | 0 | 0 | 0 | | Combined | 517 | 515 | 99.6 | 36 | 35 | 97.2 | 491 | 95 | 25 | 26 | 0 | 0 | EA-Essential Agreement CA-Category Agreement R-resistant isolates maj-major discrepancies vmj-very major discrepancies min- minor discrepancies Evaluable results are those that fall within the test range of the reference method and could also be on-scale with the new device if within the plus/minus one well variability. EA is when there is agreement between the reference method and the VITEK® 2 within plus or minus one serial two-fold dilution of antibiotic. CA is when the interpretation of the reference method agrees exactly with the interpretation of the VITEK® 2 result. ## Manual Dilution: The challenge set of organisms was also tested at one site using the manual method of inoculation with the following performance that demonstrated that there was little or no difference between the two inoculation methods. Challenge set using manual dilution | | total | EA | %EA | Total evaluable | EA of evaluable | %EA | CA | %CA | #R | min | maj | vmj | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | challenge | 53 | 53 | 100 | 0 | 0 | | 53 | 100 | 0 | 0 | 0 | 0 | b. Matrix comparison: Not applicable 3. Clinical studies: a. Clinical sensitivity: Not applicable b. Clinical specificity: Not applicable c. Other clinical supportive data (when a and b are not applicable): Not applicable 4. Clinical cut-off: Not applicable 5. Expected values/Reference range: $\leq 1$ (S), $2$ (I), $\geq 4$ (R) The expected value range, interpretative criteria and QC are the same as recommended in NCCLS. All values will be included in the package insert. ## M. Conclusion: The reproducibility, quality control results and overall performance is acceptable as described in the "Class II Special Controls Guidance Document: Antimicrobial {4} Page 5 of 5 Susceptibility Test (AST) Systems; Guidance for Industry and FDA" which was used in the design and evaluation of the study. The appropriate control organisms are included in the labeling and are the same as those recommended in the NCCLS M7-(M100-S13) document. This performance as compared to a standard method demonstrates substantial equivalency to the predicate. --- **Source:** [https://fda.innolitics.com/device/K031865](https://fda.innolitics.com/device/K031865) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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