(28 days)
Not Found
No
The summary describes an automated system for antimicrobial susceptibility testing based on the doubling dilution technique and monitoring bacterial growth. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is described as a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents," indicating it is an in vitro diagnostic tool rather than a therapeutic device.
Yes
The device is designed for antimicrobial susceptibility testing of Streptococcus species, which is a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. This information is used to diagnose the susceptibility of bacteria to antibiotics, guiding treatment decisions.
No
The device description clearly states it is a physical AST card containing wells with antibiotics and culture media, intended for use with the VITEK® 2 Systems which are automated or manual filling/sealing/incubating/reading systems. This involves significant hardware components and physical consumables.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The document explicitly states the device is "designed for antimicrobial susceptibility testing of Streptococcus species" and is intended for use "as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents." The term "in vitro" is a key indicator of an IVD.
- Device Description: The description details how the device tests bacterial isolates outside of the body by diluting them and exposing them to antibiotics in a controlled environment (the wells of the card). This is the core principle of in vitro testing.
- Performance Studies: The performance studies describe testing "clinical isolates" and comparing the results to a "CLSI broth microdilution reference method." This further confirms that the device is used to analyze biological samples (isolates from patients) in a laboratory setting.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K121863) indicates that this device has gone through a regulatory submission process, which is typical for IVDs. The predicate device itself is also an AST (Antimicrobial Susceptibility Test), which falls under the category of IVDs.
Therefore, based on the provided information, the VITEK® 2 Streptococcus Moxifloxacin device is clearly an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
LON
Device Description
The VITEK® 2 AST card is essentially a miniaturized, abbreviated and automated version of the doubling dilution technique for determining the minimum inhibitory concentration (MIC). Each VITEK® 2 AST card contains 64 wells. A control well which only contains microbiological culture media is resident on all cards. The remaining wells contain premeasured portions of a specific antibiotic combined with culture media. The bacterial or yeast isolate to be tested is diluted to a standardized concentration with 0.45 - 0.5% 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, sealing and loading operation. The VITEK® 2 Systems monitor the growth of each well in the card over a defined period of time. 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 test contained on the card.
The VITEK® 2 AST-ST Moxifloxacin for Streptococcus species has the following concentrations in the card: 0.5. 1, 4 and 8 µg/ml (equivalent standard method concentration by efficacy in µg/mL). The MIC result range for the VITEK 2 card is 4 µg/mL.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For prescription use only.
For use with the VITEK® 2 and VITEK® 2 Compact Systems.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Performance was established through a clinical study conducted at three external study sites. A total of 951 clinical isolates were tested by the VITEK® 2 AST-ST Moxifloxacin card on the VITEK® 2 System. The majority of the isolates were recovered from clinical specimens. Two hundred twenty-nine of the 951 clinical isolates (24.1%) were stock isolates. Ten of the isolates failed to grow in the VITEK® 2 card giving a no growth rate of 1.1% (10/951). Therefore, the total number of viable clinical isolates evaluated was 941.
Testing of the clinical isolates was performed using the automated method of inoculation and the challenge organisms were tested with both the manual and automatic dilution methods. Each isolate was tested by VITEK® 2 AST-ST Moxifloxacin and the CLSI broth microdilution reference method. The inoculum was prepared with direct colony suspensions.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Reproducibility Study, Method Comparison Study (Clinical and Challenge)
Reproducibility Study Sample Size: A total of 270 test results from 10 isolates (two Streptococcus pneumoniae, two Streptococcus agalactiae, and six viridans group streptococci) tested in triplicate over three days at three external clinical sites.
Method Comparison Study (Clinical) Sample Size: 951 clinical isolates (941 viable)
Method Comparison Study (Challenge) Sample Size: 159 isolates
Key Results:
Reproducibility: The overall reproducibility was > 95% with +/- one dilution observation for the VITEK® 2 and the VITEK® 2 Compact system.
VITEK® 2 (Auto Dilution): Best Case 100%, Worst Case 100%
VITEK® 2 Compact (Manual Dilution): Best Case 99.3%, Worst Case 99.3%
Quality Control: Results for VITEK® 2 AST-ST Moxifloxacin were within the expected QC results range > 95% of the time for both the automatic and manual dilution options of the VITEK® 2. A similar QC study for VITEK® 2 Compact also showed results within expected QC ranges.
Method Comparison (Combined Clinical and Challenge Data - Auto Dilution):
Total isolates: 1100
Essential Agreement (EA) N: 1029 (93.5%)
Evaluable Essential Agreement (Eval EA) N: 1010 (94.0%)
Category Agreement (CA) N: 1094 (99.5%)
Discrepancies: 9 #R, 0 #vmj, 0 #maj, 6 #min
For the combined Streptococcus species and S. pneumoniae, 6 (0.5%) minor categorical errors were observed, with a total EA of 93.5%, evaluable EA of 94.0%, and a CA of 99.5%. The clinical study demonstrated a trend, which was one doubling dilution higher when compared to the reference method. Of the 1100 Streptococci, 9 isolates of the Streptococcus viridans group were resistant with no very major errors.
Method Comparison (Challenge Data - VITEK® 2 Manual Dilution):
Total isolates: 159
Essential Agreement (EA) N: 152 (95.6%)
Evaluable Essential Agreement (Eval EA) N: 151 (95.6%)
Category Agreement (CA) N: 158 (99.4%)
Discrepancies: 0 #R, 0 #vmj, 0 #maj, 1 #min
Method Comparison (Challenge Data - VITEK® 2 Compact Manual Dilution):
Total isolates: 159
Essential Agreement (EA) N: 152 (95.6%)
Evaluable Essential Agreement (Eval EA) N: 151 (95.6%)
Category Agreement (CA) N: 157 (98.7%)
Discrepancies: 0 #R, 0 #vmj, 0 #maj, 2 #min
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement (EA)
Category Agreement (CA)
Major Discrepancies (maj)
Very Major Discrepancies (vmj)
Minor Discrepancies (min)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
SEP 1 3 2013
l
Image /page/0/Picture/1 description: The image shows the logo for bioMerieux. The logo consists of a black circle with a vertical line through it, with the left side of the circle having horizontal lines. The text "BIOMERIEUX" is written in a sans-serif font below the circle.
510(k) SUMMARY
VITEK® 2 AST-ST Moxifloxacin
510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Nathan Hardesty |
| Staff Regulatory Affairs Specialist | |
| Phone Number: | 314-731-8666 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | September 10, 2013 |
A. 510(k) Number:
B. Purpose for Submission:
Substantial equivalence determination for the addition of Moxifloxacin to the VITEK® 2 and VITEK® 2 Compact Antimicrobial Susceptibility Test (AST) Systems for the testing of Streptococcus species.
C. Measurand:
VITEK® 2 AST-ST Moxifloxacin concentrations of 0.5, 1, 4 and 8 µg/ml. The MIC result range of the card is ≤ 0.06 -> 4 µg/mL.
D. Type of Test:
The minimum inhibitory concentration (MIC) is determined using a quantitative growth based detection algorithm according to a predetermined growth threshold.
E. Applicant:
bioMérieux, Inc.
1
F. Proprietary and Established Names:
VITEK" 2 Streptococcus Moxifloxacin VITEK® 2 AST-ST Moxifloxacin
G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| LON | |||
| System, Test, Automated, | |||
| Antimicrobial | |||
| Susceptibility, Short | |||
| Incubation | Class II | 21 CFR 866.1645 | |
| Short-Term | |||
| Antimicrobial | |||
| Susceptibility Test | |||
| System | 83 | ||
| Microbiology |
H. Intended Use:
l. 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
-
- Indication(s) for use:
2
VITEK® 2 Streptococcus 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 the 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 isolates 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.
-
- Special conditions for use statement(s):
For prescription use only.
- Special conditions for use statement(s):
-
- Special instrument requirements:
For use with the VITEK® 2 and VITEK® 2 Compact Systems.
- Special instrument requirements:
I. Device Description:
The VITEK® 2 AST card is essentially a miniaturized, abbreviated and automated version of the doubling dilution technique for determining the minimum inhibitory concentration (MIC). Each VITEK® 2 AST card contains 64 wells. A control well which only contains microbiological culture media is resident on all cards. The remaining wells contain premeasured portions of a specific antibiotic combined with
3
3
culture media. The bacterial or yeast isolate to be tested is diluted to a standardized concentration with 0.45 - 0.5% 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, sealing and loading operation. The VITEK® 2 Systems monitor the growth of each well in the card over a defined period of time. 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 test contained on the card.
The VITEK® 2 AST-ST Moxifloxacin for Streptococcus species has the following concentrations in the card: 0.5. 1, 4 and 8 µg/ml (equivalent standard method concentration by efficacy in µg/mL). The MIC result range for the VITEK 2 card is 4 µg/mL.
| VITEK® 2
AST-ST | Equivalent Standard Method Concentration
by Efficacy in µg/mL | MIC Ranges and FDA
Categories*
MIC in µg/mL: | | |
|--------------------|------------------------------------------------------------------|----------------------------------------------------|---|-----|
| | | S | I | R |
| Moxifloxacin | 0.5, 1, 4, and 8 | ≤ 1 | 2 | ≥ 4 |
The MIC ranges, interpretive criteria and equivalent concentrations are as follows:
- S = Susceptible; 1 = Intermediate; R = Resistant
J. Substantial Equivalence Information:
-
- Predicate device name(s):
VITEK® 2 AST-ST Cefotaxime
- Predicate device name(s):
-
- Predicate K number(s):
K121863
- Predicate K number(s):
3. Comparison with predicate:
| Similarities | ||
|---|---|---|
| Item | Device | Predicate |
| Intended Use | Determining quantitative | |
| antimicrobial susceptibility for | ||
| Streptococcus species | Same | |
| Inoculation and test | ||
| organism | Isolated colonies of | |
| Streptococcus species | Same | |
| Instrument | Test are run on both the | |
| VITEK® 2 and VITEK® 2 | ||
| Compact Systems | Same | |
| Test Card | VITEK® 2 card format with | Same |
4
| Similarities | ||
|---|---|---|
| Item | Device | Predicate |
| base broth | ||
| Test Method | Automated quantitative | |
| antimicrobial susceptibility test | ||
| to determine the in vitro | ||
| susceptibility of Streptococcus | ||
| species | Same |
| Differences | ||
|---|---|---|
| Item | Device | Predicate |
| Antibiotic | Moxifloxacin-specific | |
| concentrations | Cefotaxime -specific | |
| concentrations | ||
| Reading algorithm | Unique to Moxifloxacin | Unique to Cefotaxime |
| Test organisms | Streptococcus anginosus, | |
| Streptococcus constellatus, | ||
| Streptococcus pneumoniae (including | ||
| multi-drug resistant isolates | ||
| [MDRSP]), Streptococcus pyogenes, | ||
| Streptococcus agalactiae, | ||
| Streptococcus viridans group. | Streptococcus pneumoniae, | |
| Streptococcus pyogenes | ||
| (Group A beta-hemolytic | ||
| streptococci), Streptococcus | ||
| spp. |
K. Standard/Guidance Document Referenced (if applicable):
Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Guida nceDocuments/ucm071462.pdf
Clinical and Laboratory Standards Institute (CLSI) M07-A8: *Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically. Approved Standard -8th Edition". Januarv. 2009.
CLSI M100-S21, "Performance Standards for Antimicrobial Susceptibility Testing -Twenty-first Informational Supplement", January. 2011.
L. Test Principle:
Automated growth based detection using attenuation of light measured by an optical scanner. The optics used in the VITEK 2 Systems use visible light to directly measure organism growth. Optical readings are based on an initial read of a well before significant growth has begun. Light transmittance sampling at a defined interval of time for the well measures organism growth by how much light is prevented from going through the well. The VITEK®2 Systems monitor the growth of each well in the card over a defined period of time. An interpretive call is made between 4 and 16 hours for a "rapid" read but in some instances may be extended to 18 hours for GN and GP cards, up to 24 hours for some Streptococcus species, or up
5
36 hours for some yeast species. 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 on the card.
The VITEK® 2 AST-ST Moxifloxacin for Streptococcus species has the following concentrations in the card: 0.5. 1. 4. and 8 ug/ml (equivalent standard method concentration by efficacy in µg/ml). The MIC result range for the VITEK® 2 card is 4 µg/mL.
M. Performance Characteristics (if/when applicable):
-
- Analytical performance:
- a. Precision/Reproducibility:
A reproducibility study was conducted at three external clinical sites. Two isolates of Streptococcus pneumoniae, two isolates of Streptococcus agalactiae, and six isolates of viridans group streptococci (i.e. three Streptococcus sobrinus, one Streptococcus infamtarius ssp. coli, and two Streptococcus downer) were tested at each site and testing with the VITEK® 2 AST-ST Moxifloxacin card was performed in triplicate over three days, resulting in a total of 270 test results. The study included both auto and manual dilution methods for the VITEK® 2 and manual dilution only for the VITEK® 2 Compact, since the VITEK® 2 Compact system does not have functionality to support automatic dilutions to inoculate the cards. For the sake of reproducibility calculations, off-scale values are handled in two ways: "best case" and "worst case" scenarios. Best case calculation for reproducibility assumes the off-scale result is within one well from the mode MIC value. Worst case calculation for reproducibility assuming the off-scale result is greater than one well from the mode MIC value.
The overall reproducibility was > 95% with +/- one dilution observation for the VITEK® 2 and the VITEK® 2 Compact system. Results were as follows:
| VITEK(R) System | Inoculation Method | Best Case | Worst Case |
|---|---|---|---|
| VITEK(R) 2 | Auto Dilution | 100% | 100% |
| VITEK(R) 2 Compact | Manual Dilution | 99.3% | 99.3% |
-
h. Linearity/assay reportable range:
Not applicable -
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
6
The recommended Streptococcus pneumoniae QC organism was tested on every test occasion with the reference method and the VITEK® 2 System. The reference method QC results were in range for every day tested. The VITEK® 2 was tested a sufficient number of times to demonstrate that the system can produce OC results in the recommended range.
Quality Control was performed during the studies using both the auto and manual methods of diluting the organisms on the VITEK® 2 System. Results demonstrated that both methods were comparable. Quality Control Results with the VITEK® 2 System for AST-ST Moxifloxacin were as follows:
| Organism | Moxifloxacin Concentration (µg/mL) | Auto Dilution | Manual Dilution | ||
|---|---|---|---|---|---|
| Reference | VITEK® 2 | Reference | VITEK® 2 | ||
| Streptococcus pneumoniae | |||||
| ATCC 49619 | |||||
| Acceptable MIC range: | |||||
| 0.06-0.25 µg/mL | 0.016 | ||||
| 0.03 | 1 | ||||
| 0.06* | 140 | 58 | |||
| 0.12* | 62 | 203 | 46 | 104 | |
| 0.25* | |||||
| 0.5* | |||||
| 1* | |||||
| 2* | |||||
| 4* | |||||
| 8 |
- VITEK® 2 Card Result Range is ≤ 0.06 -> 4 ug/mL.
Results for VITEK® 2 AST-ST Moxifloxacin were within the expected OC results range > 95% of the time for both the automatic and manual dilution options of the VITEK® 2.
A similar OC study was conducted to evaluate the VITEK® 2 Compact, a secondary option. at three sites and the results were within the expected QC ranges as shown in the table below.
| Organism | Moxifloxacin
Concentration
(µg/mL) | Manual Dilution
Reference | VITEK® 2 |
|--------------------------------------------------------------------------------------------|--------------------------------------------------------|------------------------------|------------------------------|
| Streptococcus pneumoniae ATCC 49619
Acceptable MIC range:
0.06-0.25 µg/mL | 0.016
0.03
0.06*
0.12*
0.25*
0.5*
1* |
59
44
|
102
1
|
7
| ------ | 200 100
t
t | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Bearing
1
1 | | |
| --------
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ---------------- | | 1
1 |
- VITEK® Card Result Range is ≤ 0.06 -> 4 µg/ml.
Inoculum density control was monitored using the DensiCHEK™ Plus instrument. The DensiCHEK™ Plus controls were standardized daily with all results recorded and in the expected range.
- d. Detection limit:
Not applicable.
e. Analytical specificity:
Not applicable.
-
f. Assay cut-off:
Not applicable -
- Comparison studies:
The reference method follows the CLSI approved broth microdilution testing conditions.
- Comparison studies:
| Medium: | Cation-adjusted Mueller-Hinton broth (CAMHB) supplemented with 5% lysed horse blood |
|---|---|
| Inoculum: | Direct colony suspension |
| Incubation: | 35 °C; ambient air; 20-24 hours |
Method comparison with predicate device: u.
Performance was established through a clinical study conducted at three external study sites. A total of 951 clinical isolates were tested by the VITEK® 2 AST-ST Moxifloxacin card on the VITEK® 2 System. The majority of the isolates were recovered from clinical specimens. Two hundred twenty-nine of the 951 clinical isolates (24.1%) were stock isolates. Ten of the isolates failed to grow in the VITEK® 2 card giving a no growth rate of 1.1% (10/951). Therefore, the total number of viable clinical isolates evaluated was 941.
Testing of the clinical isolates was performed using the automated method of inoculation and the challenge organisms were tested with both the manual and automatic dilution methods. Each isolate was tested by VITEK® 2 AST-ST Moxifloxacin and the CLSI broth microdilution reference method. The inoculum was prepared with direct colony suspensions. A comparison was
8
8
provided to the reference method with the agreement shown in the following tables.
There is only one set of Moxifloxacin breakpoints [≤ 1 (S). 2 (I). ≥ 4 (R)] for Streptococcus pneumoniae and Streptococcus spp. in the FDA drug label. The performance data were analyzed using the FDA breakpoints. A summary of the combined clinical and challenge data for the auto dilution method is shown in the table below.
| VITEK® 2
Auto | Total | EA
N | EA
% | Eval
EA
Tot | Eval
EA
N | Eval
EA
% | CA
N | CA
% | #R | #
vmj | #
maj | #
min |
|--------------------------------------------|-------|---------|---------|-------------------|-----------------|-----------------|---------|---------|----|----------|----------|----------|
| CLINICAL | 941 | 878 | 93.3 | 917 | 860 | 93.8 | 936 | 99.5 | 9 | 0 | 0 | 5 |
| CHALLENGE | 159 | 151 | 95.0 | 158 | 150 | 94.9 | 158 | 99.4 | 0 | 0 | 0 | 1 |
| COMBINED
(CLINICAL
AND
CHALLENGE) | 1100 | 1029 | 93.5 | 1075 | 1010 | 94.0 | 1094 | 99.5 | 9 | 0 | 0 | 6 |
Auto Dilution (VITEK® 2)
EA-Essential Agreement CA-Category Agreement #R-number of resistant isolates maj-major discrepancies vmi-very major discrepancies min-minor discrepancies
Essential agreement (EA) is when the VITER® 2 panels agree with the broth microdilution reference results exactly or within one doubling dilution of the reference method. Category agreement (CA) is when the VITEK® 2 panel result interpretation agrees exactly with the broth microdilution reference panel result interpretation. Evaluable (Eval EA) is when the MIC result is on-scale for both the VITEK® 2 and the reference method and have on-scale EA.
For the combined Streptococcus species and S. pneumoniae. 6 (0.5%) minor categorical errors were observed, with a total EA of 93.5%, evaluable EA of 94.0%, and a CA of 99.5%. The clinical study demonstrated a trend, which was one doubling dilution higher when compared to the reference method. Of the 1100 Streptococci. 9 isolates of the Streptococcus viridans group were resistant with no very major errors. The MDRSP were evaluated in the challenge study. The combined clinical and challenge set included 295 S. pneumoniae, 256 S. pyogenes, 260 S. agalactiae and 269 viridans streptococci group, in addition to 12 S. anginosus and 8 S. constellatus.
The challenge set of 159 isolates was also tested against a manual dilution method on the VITEK® 2. A summary of VITEK® 2 manual dilution data is shown in the table below.
| VITEK® 2
Manual | Total | EA
N | EA
% | Eval
EA
Tot | Eval
EA
N | Eval
EA
% | CA
N | CA
% | #R | #
vmj | #
maj | #
min |
|--------------------|-------|---------|---------|-------------------|-----------------|-----------------|---------|---------|----|----------|----------|----------|
| CHALLENGE | 159 | 152 | 95.6 | 158 | 151 | 95.6 | 158 | 99.4 | 0 | 0 | 0 | 1 |
Manual Dilution (VITEK® 2) - Challenge
9
Performance of the VITEK® 2 Compact was evaluated as a secondary procedural option. The evaluation was conducted using the same 159 challenge isolates that were tested on the VITEK® 2 system. VITEK® 2 Compact comparison testing against the reference method is shown in the table below.
Manual Dilution (VITEK® 2 Compact) - Challenge
| VITEK(R) 2
Compact
Manual | Total | EA
N | EA
% | Eval
EA
Tot | Eval
EA
N | Eval
EA
% | CA
N | CA
% | #R | #
vmj | #
maj | #
min |
|---------------------------------|-------|---------|---------|-------------------|-----------------|-----------------|---------|---------|----|----------|----------|----------|
| CHALLENGE | 159 | 152 | 95.6 | 158 | 151 | 95.6 | 157 | 98.7 | 0 | 0 | 0 | 2 |
The performance of the VITEK® 2 Compact, a secondary option, was evaluated in the reproducibility, QC, and challenge studies with acceptable results.
-
b. Matrix comparison:
Not Applicable -
- 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 -
- Clinical cut-off:
Not Applicable
- Clinical cut-off:
-
- Expected values/Reference range:
Streptococcus species and S. pneumoniae: ≤ 1 (S), 2 (I), ≥ 4 (R)
- Expected values/Reference range:
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Image /page/10/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus has a staff with a snake winding around it, and a pair of wings at the top.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W1 166-GMP Silver Spring, MD 20993-0002
September 13, 2013
bioMéricux, Inc. c/o Mr. Nathan Hardesty Staff Regulatory Affairs Specialist 595 Anglum Road Hazelwood. MO. 63042
Re: K132573
Trade/Device Name: VITEK"2 AST-ST Moxifloxacin (≤ 0.06- ≥4pg/mL) Regulation Number: 21 CFR $866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Regulatory Class: II Product Code: LON Dated: August 13, 2013 Received: August 16, 2013
Dear Mr. Hardesty:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28. 1976. the enactment date of the Medical Device Amendments. or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you. however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA is issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act s requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
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Page 2-Mr. Hardesty
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Sally A Hojvat -S
Sally A. Hojvat, M.Sc., Ph.D Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number : K132573
Device Name: VITEK® 2 AST-ST Moxifloxacin ( ≤ 0.06 -> 4 µg/mL )
Indications For Use:
VITEK® 2 Streptococcus 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 ald in the 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 isolates 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)