K Number
K163006
Device Name
VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL)
Manufacturer
Date Cleared
2017-01-24

(88 days)

Product Code
Regulation Number
866.1645
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
VITEK® 2 AST-Gram Negative Tigeovcline is designed for antimicrobial susceptibility testing of Gram negative bacilli 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 AST-Gram Negative Tigecycline is a quantitative test. Tigecycline 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: Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumonia In vitro data available but clinical significance is unknown: Citrobacter koseri Enterobacter aerogenes Serratia marcescens 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, Staphylococus spp., Enterococcus spp., and clinically significant yeast.
Device Description
The VITEK® 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology. The isolate to be tested is diluted to a standardized concentration in 0.45 - 0.50% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK® 2 automatically fills, seals and places the card into the incubator/reader. The VITEK® 2 Compact has a manual filling and sealing operation. The VITEK® 2 monitors the growth of each well in the card over a defined period of time (up to 18 hours). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card.
More Information

Not Found

No
The description focuses on automated quantitative or qualitative susceptibility testing based on monitoring growth over time, which is a standard microbiological technique, not AI/ML. There are no mentions of AI, ML, or related concepts.

No
The device is described as a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents" and is used for "automated quantitative or qualitative susceptibility testing of isolated colonies." It provides MIC values and interpretive category results for antimicrobials, which are diagnostic outputs, not therapeutic interventions.

Yes

The device is designed for antimicrobial susceptibility testing and determines the minimum inhibitory concentration (MIC) and interpretive category results, which are used to aid in the determination of in vitro susceptibility to antimicrobial agents. This provides information critical for diagnosing and guiding treatment for infections.

No

The device description clearly details physical components like "AST Cards," "saline," and the "VITEK® 2 and VITEK® 2 Compact Systems" which are hardware instruments used in the testing process. The software component is part of a larger system that includes physical consumables and instruments.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The description explicitly states it is "designed for antimicrobial susceptibility testing of Gram negative bacilli" and is intended for use "as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents." This clearly indicates testing performed outside of the body (in vitro) to provide information for diagnosis or treatment.
  • Device Description: The description details a process of testing isolated colonies in a laboratory setting using a miniaturized microdilution technique. This is a standard method for in vitro diagnostic testing.
  • Performance Studies: The document describes an "external evaluation" comparing the device's performance to a "CLSI broth microdilution reference method." This type of study is typical for validating the performance of an IVD.
  • Predicate Device: The mention of a "Predicate Device(s)" with a K number (K161227) is a strong indicator that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used to demonstrate substantial equivalence to previously cleared IVDs.

All of these points align with the definition and characteristics of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

VITEK® 2 AST-Gram Negative Tigeovcline is designed for antimicrobial susceptibility testing of Gram negative bacilli 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 AST-Gram Negative Tigecycline is a quantitative test. Tigecycline 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: Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumonia

In vitro data available but clinical significance is unknown: Citrobacter koseri Enterobacter aerogenes Serratia marcescens

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, Staphylococus spp., Enterococcus spp., and clinically significant yeast.

Product codes

LON, LTW, LTT

Device Description

VITEK® 2 AST-Gram Negative Tigecycline is designed for antimicrobial susceptibility testing of Gram negative bacilli 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 AST-Gram Negative Tigecycline is a quantitative test. The antimicrobial presented in VITEK® 2 AST-GN Cards is 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.
The isolate to be tested is diluted to a standardized concentration in 0.45 - 0.50% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK® 2 automatically fills, seals and places the card into the incubator/reader. The VITEK® 2 Compact has a manual filling and sealing operation. The VITEK® 2 monitors the growth of each well in the card over a defined period of time (up to 18 hours). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card.

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

Laboratory aid

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

An external evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to confirm the acceptability of VITEK® 2 AST-GN Tigecycline by comparing its performance with the CLSI broth microdilution reference method incubated at 16-20 hrs.

Summary of Performance Studies

VITEK® 2 AST-GN Tigecycline demonstrated substantially equivalent performance when compared with the CLSI broth microdilution reference method, as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA (Issued August 28, 2009). The data is representative of performance on both the VITEK®2 and VITEK® 2 Compact instrument platforms. VITEK® 2 AST-GN Tigecycline demonstrated acceptable performance of 98.9% overall Essential Agreement and 98.6% overall Category Agreement with the reference method. Reproducibility and Quality Control demonstrated acceptable results.

Key Metrics

98.9% overall Essential Agreement and 98.6% overall Category Agreement.

Predicate Device(s)

K161227

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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.”

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 24, 2017

BIOMÉRIEUX, INC. JENNIFER JINES REGULATORY AFFAIRS SPECIALIST 595 ANGLUM RD. HAZELWOOD MO 63042

Re: K163006

Trade/Device Name: VITEK 2 AST-GN Tigecvcline (8 ug/mL) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully automated short-term incubation cycle antimicrobial susceptibility system Regulatory Class: II Product Code: LON, LTW, LTT Dated: October 26, 2016

Received: October 28, 2016

Dear Ms. Jines:

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, listing 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's 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 (OS) 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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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education 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" (21 CFR 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 Industry and Consumer Education 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,

Ribhi Shawar -A

For Uwe Scherf, 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 (if known) K163006

Device Name VITEK® 2 AST-GN Tigecycline (≤0.5 ->8 µg/mL)

Indications for Use (Describe)

VITEK® 2 AST-Gram Negative Tigeovcline is designed for antimicrobial susceptibility testing of Gram negative bacilli 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 AST-Gram Negative Tigecycline is a quantitative test. Tigecycline 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: Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumonia

In vitro data available but clinical significance is unknown: Citrobacter koseri Enterobacter aerogenes Serratia marcescens

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, Staphylococus spp., Enterococcus spp., and clinically significant yeast.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

B.

VITEK® 2 AST-GN Tigecycline

510(k) Submission Information:

Submitter's Name:bioMérieux, Inc.
Address:595 Anglum Road
Hazelwood, MO 63042
Contact Person:Jennifer Jines
Regulatory Affairs Specialist
Phone Number:314-731-8352
Fax Number:314-731-8689
Date of Preparation:October 26, 2016
B. Device Name:
Formal/Trade Name:VITEK® 2 AST- GN Tigecycline (≤0.5 - ≥8
µg/mL)
Classification Name:21 CFR 866.1645
Fully Automated Short-Term Incubation Cycle
Antimicrobial Susceptibility System
Product Code LON
Common Name:VITEK® 2 AST-GN Tigecycline
C. Predicate Device:VITEK® 2 AST-GN Cefepime (K161227)

D. 510(k) Summary:

VITEK® 2 AST-Gram Negative Tigecycline is designed for antimicrobial susceptibility testing of Gram negative bacilli 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 AST-Gram Negative Tigecycline is a quantitative test. Tigecycline has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial.

4

Active in vitro and in clinical infections

Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumonia

In vitro data available but clinical significance is unknown Citrobacter koseri Enterobacter aerogenes Serratia marcescens

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 veast.

The antimicrobial presented in VITEK® 2 AST-GN Cards is 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.

The isolate to be tested is diluted to a standardized concentration in 0.45 - 0.50% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK® 2 automatically fills, seals and places the card into the incubator/reader. The VITEK® 2 Compact has a manual filling and sealing operation. The VITEK® 2 monitors the growth of each well in the card over a defined period of time (up to 18 hours). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card.

VITEK® 2 AST-GN Tigecycline demonstrated substantially equivalent performance when compared with the CLSI broth microdilution reference method, as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA (Issued August 28, 2009).

The Premarket Notification [510(k)] presents data in support of VITEK® 2 AST-GN Tigecycline. An external evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to confirm the acceptability of VITEK® 2 AST-GN Tigecycline by comparing its performance with the CLSI broth microdilution reference method incubated at 16-20 hrs. The data is representative of

5

performance on both the VITEK®2 and VITEK® 2 Compact instrument platforms. VITEK® 2 AST-GN Tigecycline demonstrated acceptable performance of 98.9% overall Essential Agreement and 98.6% overall Category Agreement with the reference method. Reproducibility and Quality Control demonstrated acceptable results.