VITEK 2 COMPACT

K050002 · bioMerieux, Inc. · LON · Feb 17, 2005 · Microbiology

Device Facts

• Record ID: K050002
• Device Name: VITEK 2 COMPACT
• Applicant: bioMerieux, Inc.
• Product Code: LON · Microbiology
• Decision Date: Feb 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1645
• Device Class: Class 2

Indications for Use

VITEK® 2 Compact System is intended to be used with VITEK® 2 AST Cards 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. It is intended for use as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. Antimicrobials presented in VITEK 2 AST Cards are in concentrations equivalent by efficacy to standard method concentrations in mcg/ml. The VITEK 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.

Device Story

VITEK® 2 Compact System performs automated identification and antimicrobial susceptibility testing (AST) of bacteria and yeasts. Input: isolated colonies inoculated into saline, density-adjusted via DENSICHECK, and loaded into 64-well AST cards. Operation: vacuum-filled cards placed in cassettes; carousel incubation at 35.5°C; automated optical reading every 15 minutes using 660 nm LEDs and silicon photodetectors to measure turbidity/growth. System includes workstation PC, printer, and Advanced Expert System (AES) for phenotype detection and therapeutic guidance. Output: AST results, identification reports, and QC data. Used in clinical laboratories; operated by lab technicians. Bidirectional interface transfers results to LIS. Benefits: standardized, automated susceptibility testing; rapid phenotype detection; improved clinical decision-making for antimicrobial therapy.

Clinical Evidence

External evaluations conducted at six sites using challenge, reproducibility, and quality control samples for gram-negative and gram-positive organisms. Results: 99.4% agreement for challenge testing vs. VITEK 2; 100% essential agreement for reproducibility; 97.79% essential agreement for precision dilution differences; 99.04% in-range for quality control.

Technological Characteristics

Automated short-term incubation system. Uses VITEK 2 AST cards (miniaturized doubling dilution). Sensing principle: optical scanner measuring light attenuation. Connectivity: automated reporting. Software: automated growth monitoring and MIC calculation.

Indications for Use

Indicated for automated quantitative or qualitative antimicrobial susceptibility testing of isolated colonies of clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.

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 System (N50510/S82)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY TEMPLATE

A. 510(k) Number:
K050002

B. Purpose for Submission:
To introduce a smaller version of the VITEK® 2 with new software

C. Manufacturer and Instrument Name:
bioMerieux, Inc. – VITEK®2 Compact

D. Type of Test or Tests Performed:
In vitro diagnostic test software used for identification and antimicrobial susceptibility testing of organisms

E. System Descriptions:

1. Devise Description:
The VITEK® 2 Compact System is dedicated to the identification of bacteria and yeasts and susceptibility testing of clinically significant bacteria using the VITEK® 2 Product line of cards. The system includes the VITEK® 2 Compact instrument, a computer (workstation) and printer. The system software is a component used to support the VITEK®2 Compact instrument and runs in a PC environment. The system includes an Advanced Expert System (AES) for clinical use, provides therapeutic guidance for advanced analysis of results and the detection of phenotypes. The user documentation available with the workstation software is in Adobe PDF format (Software User Manual and the Online Product information open in PDF format). The system allows the user to manage and enter patient and specimen information; interpret organism identification from biochemical test results using a set of claimed organisms/reactions; manage Quality Control (QC); view and modify configuration parameters; and create new AST card definitions, search audit history and archive reports. A bidirectional computer interface transfers results automatically to the user's laboratory information system (LIS) and to various product and patient reports.

2. Principles of Operation:
The system software is a component used to support the VITEK®2 Compact instrument and runs in a PC environment. Transmittance Optics uses visible light

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to directly measure organism growth. The optics use light emitting diodes (LEDs) which produce light at the appropriate wavelengths and silicon photodetectors to capture the transmitted light.

3. Modes of Operation:

Automated reading of growth based AST cards in cassettes. Each card is transferred from the cassette to a card loader to place into a slot on a carousel where it remains throughout its incubation. Each carousel has a capacity of 30 to 60 cards and is kept at a temperature of 35.5° C. As the carousel rotates each test card moves into the reading position every 15 minutes. At the completion of the reading the card is ejected into the waste collection station.

4. Specimen Identification:

Patient information may be entered manually or downloaded from a data management system. The instrument reads the bar code information from the cards and cassettes and automatically sends the information to the system software.

5. Specimen Sampling and Handling:

Isolated colonies are inoculated into saline and then the density adjusted to a McFarland standard using a VITEK®2 DENSICHECK. Specimens are inoculated into test cards which are placed in a cassette.

6. Calibration:

Self calibrating.

7. Quality Control:

QC isolates are tested according to the type of panel used. Expected ranges are listed for each antibiotic and organism.

8. Software:

FDA has reviewed applicant's Hazard Analysis and Software Development processes for this line of product types:

Yes ☐ X ☐ or No ☐

F. Regulatory Information:

1. Regulation section:

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866.1645

2. Classification:

Class II

3 Product code:

LON

4. Panel:

83 Microbiology

## G. Intended Use:

1. Indication(s) for Use:

The VITEK® 2 Compact System is intended to be used 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.

2. Special Conditions for Use Statement(s):

For prescription use.

For testing the VITEK® 2 Systems Products

## H. Substantial Equivalence Information:

1. Predicate Device Name(s) and 510(k) numbers:

VITEK® 2 System N50510/S82

2. Comparison with Predicate Device:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | The VITEK® 2 Compact is intended to be used for the automated quantitative or qualitative susceptibility testing of isolated colonies for most clinically significant | The VITEK® 2 is intended to be used for the automated quantitative or qualitative susceptibility testing of isolated colonies for most clinically significant |

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| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae and S. pneumoniae. | aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae and S. pneumoniae. |
| Test Cards | 64 well card with antibiotics in varying concentrations dried with a microbiological medium | same |
| AST CARD inoculum | Isolated colonies prepared with a DENSICHECK densitometer | same |
| Filling and Sealer process | Vacuum filled and automated heat seal | same |
| Incubation and reading | Automated, 35.5°C +/- 1° with automated readings every 15 minutes with 660 nm optics | same |
| AST analysis | Analysis of changes in growth based turbidity | same |
| Advanced Expert System | Yes | Yes |
| Waste | Automated removal of ejected test cards to waste container at end of cycle | Automated removal of ejected test cards to waste container at end of cycle |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Instrument Capacity | 30-60 cards | 60-120 cards |
| Computer | HP/Compaq Windows XP Pro PC with Pentium 4 processor | IBM AIX Workstation with RISC6000 processor |
| Test set up | Visual Smart Carrier Test setup at Workstation downloaded to instrument | Smart Carrier Test setup programmed onto embedded programmable chip in card cassette then downloaded to instrument |
| Cassette | 10 cards/cassette | 15 cards/cassette |
| AST dilution preparation step and filling process | Manual dilution only with two step filling process | Automated or manual dilution with automated filling process with automated timing control |
| QC Results | Provides a side-by-side | No comparison of |

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| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | comparison of expected versus actual QC results | expected results versus actual QC results. |

I. Special Control/Guidance Document Referenced (if applicable):

“Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA”; CLSI M7 (M100-S15) “Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard”; “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices”.

J. Performance Characteristics:

1. Analytical Performance:

a. Accuracy:

A challenge phase of testing was performed to confirm the agreement in results over a broad range of organisms using the AST test cards. Each organism was inoculated into 2 cards to be tested on each system at each of three sites. Overall agreement performance was >95% for gram negative organisms (n = 8,002 results) gram positive organisms (n=6480 results) and *Streptococcus pneumoniae* (n = 1, 215 results). Quality control isolates were also tested a sufficient number of times on each instrument with results in the expected range in the criterion set up for the study that there would be no decrease of more than 2.5% in the rate of results falling within range from the VITEK® 2 to the VITEK® 2 Compact. Studies were performed to demonstrate that AST results are essentially equivalent when using either the VITEK® 2 or the VITEK® 2 Compact. The primary difference between the two systems is the test disposable filling and sealing process and this was demonstrated to have no significant impact on product performance.

b. Precision/Reproducibility:

A study was performed to provide the best comparison for the two systems for accuracy and precision. For accuracy the medians should agree within +/- 1 doubling dilution at a rate greater than 95% and for precision the rate of results falling within plus or minus one 2-fold serial dilution of the median of the VITEK® 2 Compact to be within 2.5% of the rate of results falling within plus or minus one 2-fold serial dilution of the VITEK® 2. These were met with no obvious suggestion of trending of an instrument bias in one direction.

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c. Linearity:
Not applicable

d. Carryover:
Not Applicable

e. Interfering Substances:
Not Applicable

2. Other Supportive Instrument Performance Data Not Covered Above:
Not Applicable

K. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

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