← Product Code [LON](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON) · K043230

# VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR ERTAPENEM (K043230)

_bioMerieux, Inc. · LON · Dec 30, 2004 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K043230

## Device Facts

- **Applicant:** bioMerieux, Inc.
- **Product Code:** [LON](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON.md)
- **Decision Date:** Dec 30, 2004
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.1645
- **Device Class:** Class 2
- **Review Panel:** Microbiology
- **Attributes:** AI/ML

## Indications for Use

The VITEK® Gram Negative Susceptibility Test is intended to be used with the VITEK® 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, and S. pneumoniae. VITEK® Gram Negative Ertapenem is designed for antimicrobial susceptibility testing of Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii, Citrobacter koseri, Enterobacter aerogenes, Enterobacter cloacae, Klebsiella oxytoca (excluding ESBL producing strains), Morganella morganii, Proteus mirabilis, Proteus vulgaris and Serratia marcescens. VITEK Gram Negative Ertapenem is for qualitative testing only. It is intended for use with the VITEK System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.

## Device Story

VITEK® Gram Negative Susceptibility Card is a 45-well test card used with the VITEK® System. Clinical laboratory personnel inoculate the card with a saline-diluted suspension of isolated gram-negative bacilli using a vacuum filling process. The VITEK® Reader/Incubator optically monitors organism growth via light attenuation in wells over a 6–15 hour incubation cycle. The system uses regression and discriminate analysis to process growth characteristics and organism identification to determine susceptibility results. The device outputs qualitative SIR (Susceptible, Intermediate, Resistant) interpretations. This automated process eliminates manual handling after inoculation, providing standardized susceptibility testing to guide antimicrobial therapy decisions.

## Clinical Evidence

External evaluation conducted using fresh and stock clinical isolates and stock challenge strains. Performance compared to NCCLS agar dilution reference method. Results showed 98.7% overall Category Agreement. Reproducibility and Quality Control testing yielded acceptable results.

## Technological Characteristics

Miniaturized microdilution card for use with the VITEK System. Automated short-term incubation and growth monitoring. Measures antimicrobial susceptibility via growth threshold detection. Qualitative testing only.

## 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® Gram Negative Susceptibility Card for Gatifloxacin (k032711)

## Submission Summary (Full Text)

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>
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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE

A. 510(k) Number:
k043230

B. Purpose for Submission:
Addition of ertapenem to the Vitek® Antimicrobial Susceptibility Test (AST) System

C. Measurand:
Ertapenem ≤0.5 – ≥8 μg/mL

D. Type of Test:
Qualitative AST growth based detection

E. Applicant:
bioMerieux, Inc.

F. Proprietary and Established Names:
VITEK® Gram Negative Susceptibility Card

G. Regulatory Information:

1. Regulation section:
21 CFR 866.1645 Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System

2. Classification:
II

3. Product code:
LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

4. Panel:
83 Microbiology

H. Intended Use:

1. Intended use(s):
The VITEK® Antimicrobial Susceptibility Test is intended to be used with the VITEK® System for the automated quantitative or qualitative susceptibility testing of isolated colonies for most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.

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The VITEK® Gram Negative Susceptibility Card is intended for use with the VITEK® system in clinical laboratories as an in vitro test to determine the susceptibility of rapidly growing aerobic and/or facultatively anaerobic, gram-negative bacilli to antimicrobial agents when used as instructed in the “pinsert” and operator’s manual.

2. **Indication(s) for use:**
This submission is for the addition of the antibiotic ertapenem at concentrations of 0.5, 1, and 2 ug/ml for a calling range of ≤ 0.5 – ≥ 8 µg/mL on the VITEK® Gram Negative Susceptibility Card to provide qualitative results (SIR).

3. **Special conditions for use statement(s):**
For prescription use only
Qualitative SIR reading only, MIC results not available

4. **Special instrument requirements:**
N/A

I. **Device Description:**
Each VITEK® test card contains 45 wells. The positive control well determines organism growth without antimicrobial inhibition. A suspension of the isolate to be tested is diluted with 0.45 – 0.5% sterile saline. The VITEK® Card is inoculated with the diluted suspension using a vacuum filling process in the VITEK® Filling Module. After the card is inoculated and placed inside the VITEK® Reader/Incubator, no further handling is required. Organism growth inside the card is optically monitored throughout the 6 – 15 hour incubation cycle.

J. **Substantial Equivalence Information:**

1. **Predicate device name(s):**
VITEK® Gram Negative Susceptibility Card for Gatifloxacin

2. **Predicate 510(k) number(s):**
k032711

3. **Comparison with predicate:**

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|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  Intended Use | Determine antimicrobial susceptibility to antimicrobial agents | Same  |
|  Test Organism | Gram Negative Bacilli | Same  |
|  Test Card | VITEK® card format with base broth | Same  |
|  Instrument | VITEK® System | Same  |
|  Differences  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  Antibiotic | Ertapenem at specific concentrations | Gatifloxacin at specific concentrations  |
|  Reading algorithm | Unique for ertapenem | Unique for gatifloxacin  |

# K. Standard/Guidance Document Referenced (if applicable):

"Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test Systems; Guidance for Industry and FDA"; NCCLS M7 (M100-S14) "Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard."

# L. Test Principle:

The VITEK® System determines when a well demonstrates growth (positive) based on the attenuation of light measured by optical scanner. Organism growth is expressed as increased turbidity in wells. Optical measurements are taken on an hourly basis. If during the 6 - 15 hour incubation cycle, bacterial growth occurs at levels equal to or greater than a predetermined threshold, regression analysis is utilized, along with the organism's identification, to determine the appropriate MIC value for the antimicrobial. The VITEK® Susceptibility Card test is based on the microdilution minimum inhibitory concentration technique with concentrations equivalent to standard method concentrations. Several parameters based on the growth characteristics observed are used to provide appropriate input for calculations. Discriminate analysis is used to develop the algorithm that determines the susceptibility result for all antimicrobials on the VITEK® system. An algorithm of using the 3 dilutions on the card allows for a calling range of  $\leq 0.5 - \geq 8\mu \mathrm{g / mL}$ . The AST result must be linked to organism identification in order to determine a category interpretation. A category interpretation (SIR) will be reported.

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# M. Performance Characteristics (if/when applicable):

## 1. Analytical performance:

a. Precision/Reproducibility:

Reproducibility within sites was determined using the Quality Control (QC) isolates for >95% reproducibility. Between sites was performed at three sites for three days in triplicate for >95% reproducibility on 10 isolates.

b. Linearity/assay reportable range:

Not applicable

c. Traceability, Stability, Expected values (controls, calibrators, or methods): The recommended QC isolates were tested on every test occasion with the reference method and the VITEK®. The expected range for the E. coli with the reference method was ≤0.25 μg/mL and QC results were in range for every day tested. The expected range for the E. coli with the VITEK® was ≤ 0.50 μg/mL and was tested a sufficient number of times to demonstrate that the system can produce QC results in the recommended range. The mode for the Vitek® was the same for the E. coli and P. aeruginosa.

Quality Control Table

|  ORGANISM | Vitek® Conc. | Vitek® | Reference Conc. | Reference  |
| --- | --- | --- | --- | --- |
|  |   |   |   |   |
|  E. coli | ≤0.50 | 66 | ≤0.25 | 66  |
|  ATCC 25922 | 1 |  | 0.50 |   |
|  Expected Range: | 2 |  | 1 |   |
|  ≤0.06 μg/ml | 4 |  | 2 |   |
|  |   |   |   |   |
|  P. aeruginosa | 1 |  | 1 |   |
|  ATCC 27853 | 2 | 2 | 2 | 14  |
|  Expected Range: | 4 | 62 | 4 | 53  |
|  2 - 8 μg/ml | 8 | 3 | 8 | 1  |
|  |   |   |   |   |

Inoculum density control was monitored using a colorimeter and colony count. This was standardized weekly with all results recorded and in the expected range. Verification was performed during internal testing.

A 0.5 McFarland is used to determine the correct inoculum. Colony counts were performed periodically at each site to demonstrate that the inoculum procedure results were in the expected CFU/ml.

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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:

A clinical study was conducted at three sites using the VITEK® gram negative cards with ertapenem and the reference agar dilution method as recommended by the NCCLS. Inoculum was prepared with direct colony suspension. The testing included both fresh clinical isolates and stock isolates along with a challenge set with known results. The test device had a growth rate of  $>90\%$ . Essential agreement was not calculated because the Vitek card contained  $< 5$  dilutions of ertapenem. A comparison was provided to the reference method with the following agreement.

Summary Table for Enterobacteriaceae spp.

|   | CA Tot | CA N | CA % | #R | Min | maj | vmj  |
| --- | --- | --- | --- | --- | --- | --- | --- |
|  Clinical | 301 | 297 | 98.7 | 2 | 4 | 0 | 0  |
|  Challenge | 77 | 76 | 98.7 | 3 | 1 | 0 | 0  |
|  Combined | 378 | 373 | 98.7 | 5 | 5 | 0 | 0  |

CA-Category Agreement

R-resistant isolates

min-minor discrepancies

maj-major discrepancies

vmj-very major discrepancies

CA is when the interpretation of the reference method agrees exactly with the interpretation of the VITEK® results.

b. Matrix comparison:

Not Applicable

# 3. Clinical studies:

a. Clinical Sensitivity:

Not Applicable

b. Clinical specificity:

Not Applicable

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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: Enterobacteriaceae ≤ 2 (S), 4 (I), ≥8 (R)

The Interpretative criteria, QC isolates and the expected ranges are the same as recommended by the NCCLS and the FDA. All values will be included in the package insert.

The ability of the VITEK® system to detect resistance to ertapenem is unknown because resistant organisms were not available at the time of comparative testing.

N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:

1. The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K043230](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K043230)

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