VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE
Device Facts
| Record ID | K103752 |
|---|---|
| Device Name | VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE |
| Applicant | bioMerieux, Inc. |
| Product Code | LON · Microbiology |
| Decision Date | Oct 14, 2011 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.1645 |
| Device Class | Class 2 |
Indications for Use
VITEK® 2 GN Imipenem is designed for antimicrobial susceptibility testing of Gram-negative bacilli. VITEK 2 GN Imipenem is a quantitative test intended for use with the VITEK 2 and VITEK 2 Compact Systems using VITEK 2 Systems 5.02 Software as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. Imipenem 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 antimicrobial. Active in vitro and in clinical infections: Acinetobacter spp., Citrobacter spp., Enterobacter aerogenes, Escherichia coli, Klebsiella spp., Morganella morganii, Proteus vulgaris, Providencia rettgeri, Pseudomonas aeruginosa, Serratia marcescens. Active in vitro but clinical significance unknown: Providencia stuartii. 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. The VITEK 2 Systems (PC) 5.02 Software is intended for use with VITEK 2 and VITEK 2 Compact Systems.
Device Story
VITEK 2 system performs automated antimicrobial susceptibility testing (AST) on isolated bacterial colonies. Input: bacterial isolate diluted in saline, used to rehydrate antimicrobial medium in test card. Operation: VITEK 2 automatically fills/seals card (VITEK 2 Compact uses manual fill/seal); system incubates and monitors growth in card wells over 18 hours. Output: MIC value and interpretive category result. Used in clinical laboratories by technicians/microbiologists. Output assists clinicians in selecting appropriate antimicrobial therapy by determining in vitro susceptibility of pathogens.
Clinical Evidence
Bench testing only. External evaluation compared VITEK 2 Gram Negative Imipenem performance against CLSI broth microdilution reference method using fresh clinical isolates and stock challenge strains. Results demonstrated 95.7% overall Essential Agreement and 94.8% overall Category Agreement. Reproducibility and Quality Control testing met acceptance criteria.
Technological Characteristics
Miniaturized broth microdilution AST card. Automated incubation and optical growth monitoring. Software: VITEK 2 Systems (PC) 5.02. Connectivity: VITEK 2 and VITEK 2 Compact instrument platforms. Quantitative MIC determination.
Indications for Use
Indicated for antimicrobial susceptibility testing of isolated colonies of clinically significant aerobic Gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, S. pneumoniae, and yeast. Used as a laboratory aid to determine in vitro susceptibility to antimicrobial agents.
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.”
Predicate Devices
- VITEK® 2 Gram Negative Meropenem (k091899)
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE
A. 510(k) Number:
k103752
B. Purpose for Submission:
To obtain clearance for the addition of Imipenem to the VITEK® 2 and VITEK®2 Compact Systems Antimicrobial Susceptibility Test (AST) Systems using VITEK 2 Systems (PC) 5.02 Software.
C. Measurand
Imipenem concentrations (≤ 0.25- ≥ 16 μg/mL)
D. Type of Test:
Quantitative growth based detection algorithm using optics light detection
E. Applicant:
bioMérieux, Inc.
F. Proprietary and Established Names:
Vitek®2 Gram Negative Imipenem with VITEK 2 Systems (PC) 5.02 Software
G. 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
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H. Intended Use:
1. Intended use(s):
VITEK® 2 GN Imipenem is designed for antimicrobial susceptibility testing of Gram Negative bacilli. VITEK® 2 GN Imipenem is a quantitative test intended for use with the VITEK® 2 and the VITEK® 2 Compact Systems using VITEK 2 Systems (PC) 5.02 Software as a laboratory aid in the determination of *in vitro* susceptibility to antimicrobial agents. Imipenem 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 antimicrobial.
Active *in vitro* and in clinical infections:
- Acinetobacter spp
- Citrobacter spp
- Enterobacter aerogenes
- Escherichia coli
- Klebsiella spp
- Morganella morganii
- Proteus vulgaris
- Providencia rettgeri
- Pseudomonas aeruginosa
- Serratia marcescens
Active *in vitro* but clinical significance unknown:
- Providencia stuartii
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. The VITEK 2 Systems (PC) 5.02 Software is intended for use with VITEK 2 and VITEK 2 Compact Systems.
2. Indication(s) for use:
VITEK® 2 GN Imipenem is designed for antimicrobial susceptibility testing of Gram Negative bacilli. VITEK® 2 GN Imipenem is a quantitative test intended for use with the VITEK® 2 and the VITEK® 2 Compact Systems using VITEK 2 Systems (PC) 5.02 Software as a laboratory aid in the determination of *in vitro* susceptibility to antimicrobial agents. Imipenem has been shown to be active both *in vitro* and in clinical infections against most
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strains of the following microorganisms according to the FDA label for the antimicrobial.
Active in vitro and in clinical infections:
- Acinetobacter spp
- Citrobacter spp
- Enterobacter aerogenes
- Escherichia coli
- Klebsiella spp
- Morganella morganii
- Proteus vulgaris
- Providencia rettgeri
- Pseudomonas aeruginosa
- Serratia marcescens
Active in vitro but clinical significance unknown:
- Providencia stuartii
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. The VITEK 2 Systems (PC) 5.02 Software is intended for use with VITEK 2 and VITEK 2 Compact Systems.
3. Special condition for use statement(s):
- Prescription Use Only
4. Special instrument Requirements:
- VITEK® 2 and the VITEK® 2 Compact Systems
I. Device Description:
Each VITEK® 2 test card contains 64 micro-wells. A control well which contains only microbiological culture media is resident on all cards, with the remaining wells containing premeasured amounts of a specific antibiotic combined with culture medium. A suspension of organism is made in 0.45 sterile saline from a pure culture and standardized to a 0.5 McFarland standard using the DensiChek2. The desired card(s) are placed in the cassette along with an empty tube for the susceptibility card. The VITEK® 2 System automatically vacuum fills, seals and places the card into the incubator/reader. The VITEK® 2 Compact has a manual filling, sealing and loading operation. Cards are then transferred from the cassette into the carousel for incubation (35.50 C) and optical scanning during testing.
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Optics systems use visible light to directly measure organism growth. This transmittance optics is 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. Readings are performed every 15 minutes. An interpretive call is made between 4 and 16 hours for a "rapid" read but may be extended to 18 hours in some instances. The VITEK® 2 Susceptibility Card test is based on the microdilution minimum inhibitory concentration (MIC) technique with concentrations equivalent to standard method concentrations. Several parameters based on the growth characteristics observed are used to provide appropriate input for the MIC calculations. Growth pattern 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 organism identification in order to determine a category interpretation. A category interpretation will be reported along with an MIC. This is only an auto-read result; manual readings are not possible.
The VITEK® 2 AST Gram Negative Imipenem has the following concentrations in the card: 1, 2, 6, 12 μg/mL (equivalent standard method concentration by efficacy in μg/mL). The MIC result range for the VITEK® 2 card is ≤0.25 - 16μg/mL.
J. Substantial Equivalence Information:
1. Predicate device name(s)
VITEK® 2 Gram Negative Meropenem
2. Predicate K number(s):
k091899
3. Comparison with predicate
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Determine antimicrobial susceptibility to antimicrobial agents | Same |
| Test organism | Gram Negative Rods Colonies | same |
| Test Card | VITEK® 2 card format with base broth | same |
| Instrument | VITEK® 2 and VITEK® 2 Compact System | same |
| Item | Device | Predicate |
| Antibiotic | Imipenem | Meropenem |
| Reading algorithm | Unique for Imipenem (growth pattern analysis) | Unique for Meropenem (discriminant analysis) |
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# K. Standard/Guidance Document Referenced (if applicable):
Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA"
CLSI M7 “Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard”
CLSI M100-S19 “Performance Standards for Antimicrobial Susceptibility; Twenty-First Information Supplement”
# L. Test Principle:
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 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 DensiChek2. The desired card(s) are placed in the cassette along with an empty tube for the susceptibility card. The cassette is placed in the VITEK®2 instrument where a susceptibility test will be automatically diluted from the ID suspension by the VITEK®2. 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.
In addition to the automatic dilution, there is also a manual inoculation dilution procedure described in the packager insert.
# M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Reproducibility was demonstrated using 10 isolates at 3 sites on 3 separate days in triplicates. The study included the Auto-dilution and the Manual dilution with the VITEK®2, and the Manual dilution with the VITEK®2 Compact. All results were >95% reproducible.
b. Linearity/assay reportable range:
Not Applicable
c. Traceability (controls, calibrators, or method):
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The recommended QC isolates were tested on every test occasion with the reference method and the VITEK®2. 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 QC results in the recommended range.
Quality Control was performed during the studies using both the auto-dilution and the manual method of diluting the organisms. Results demonstrated that methods were comparable with the same mode.
Quality Control Summary (VITEK®2, Auto and Manual dilution)
| Organism | Conc. in μg/ml | Auto-dilution | | Manual dilution | |
| --- | --- | --- | --- | --- | --- |
| E. coli
ATCC 25922
Expected Range
0.06- 0.25 μg/ml | | Ref. | Test | Ref. | Test |
| | 0.06 | 1 | | | |
| | 0.125 | 55 | | 24 | |
| | 0.25 | 68 | 124 | 48 | 72 |
| | 0.5 | | | | |
| | | | | | |
| P. aeruginosa
ATCC 27853
Expected Range
1- 4 μg/ml | 1 | 30 | | 9 | |
| | 2 | 87 | 121 | 60 | 72 |
| | 4 | 5 | | 3 | |
| | 8 | | | | |
| | 16 | | 1 | | |
| | | | | | |
An additional QC study was performed with the VITEK®2 Compact, the secondary option, at three sites, with the following results.
Quality Control Summary (VITEK®2 Compact, Manual dilution)
| Organism | Conc. in μg/ml | Manual-dilution | |
| --- | --- | --- | --- |
| E. coli
ATCC 25922
Expected Range
0.06- 0.25 μg/ml | | Ref. | Test |
| | 0.06 | | |
| | 0.125 | 57 | |
| | 0.25 | 3 | 60 |
| | 0.5 | | |
| | | | |
| P. aeruginosa
ATCC 27853
Expected Range
1- 4 μg/ml | 1 | 40 | |
| | 2 | 20 | 60 |
| | 4 | | |
| | 8 | | |
| | 16 | | |
Inoculum density control was monitored using the DensiChek2 instrument. This was standardized weekly with all results recorded and in the expected range. Verification was performed during internal testing.
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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:
Clinical study was performed at four external sites using the VITEK 2 Gram Negative Imipenem and broth microdilution panels containing Imipenem. A total of 608 clinical isolates were tested at four external sites by auto inoculation. The no growth rate was 1.5% (9/608); fifteen of the 599 clinical isolates were from frozen stocks (2.5%, 15/599). For comparison of auto and manual dilution, the challenge set of 246 isolates was included.
Performance Summary Table (VITEK 2, Auto Dilution)
| | total | EA | %EA | Eval EA Total | Eval EA | Eval %EA | CA | %CA | #R | min | maj | vmj |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Clinical | 599 | 576 | 96.2 | 202 | 194 | 96.0 | 569 | 95.0 | 154 | 26 | 2 | 2 |
| Challenge | 246 | 233 | 94.7 | 132 | 121 | 91.7 | 232 | 94.3 | 55 | 11 | 0 | 3 |
| Combined | 845 | 809 | 95.7 | 334 | 315 | 94.3 | 801 | 94.8 | 209 | 37 | 2 | 5 |
EA-Essential Agreement
CA-Category Agreement
R-resistant isolates
maj-major discrepancies
vmj-very major discrepancies
min- minor discrepancies
When analyzing the Serratia marcescens in the challenge study by manual method, it was noted that the EA by Compact was low at 61.5%; the CA was 100% because non-susceptible isolates are rare and might not be available for testing. However, the EA of the VITEK 2 manual dilution was high at 92.3%. An additional study was conducted with a total of 90 Serratia marcescens isolates with the following results:
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Additional performance data summary for S. marcescens
| S. marcescens | total | EA | %EA | Eval EA Total | Eval EA | Eval %EA | CA | %CA | #R | min | maj | vmj |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| VITEK2 Auto | 90 | 81 | 90.0 | 70 | 63 | 90.0 | 89 | 98.9 | 1 | 1 | 0 | 0 |
| VITEK2 Manual | 90 | 68 | 75.6 | 82 | 61 | 74.4 | 87 | 96.7 | 1 | 3 | 0 | 0 |
| Compact Manual | 90 | 71 | 78.9 | 82 | 65 | 79.3 | 87 | 96.7 | 1 | 3 | 0 | 0 |
The EA of Imipenem/Serratia marcescens was low with manual dilutions, including the VITEK®2 Compact. A limitation was in place for Imipenem/Serratia marcescens.
The performance of the optional VITEK®2 Compact was evaluated in the QC, challenge, and reproducibility studies.
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):
4. Clinical cut-off: Not Applicable
5. Expected values/Reference range
$\leq 4$ (S), $8(\mathrm{I}), \geq 16$ (R)
N. Proposed Labeling:
The labeling is sufficient and satisfies the requirement of 21 CFR Part 809.10.
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O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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