(49 days)
No
The summary describes a standard automated antimicrobial susceptibility testing system based on microdilution methodology and growth monitoring. There is no mention of AI or ML in the device description, intended use, or performance studies. The evaluation compares the device to a standard reference method, not an AI/ML model.
No.
This device is described as a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents" and is intended for use in susceptibility testing, not for direct therapeutic treatment of patients.
Yes
The device is designed for "antimicrobial susceptibility testing" and provides "in vitro susceptibility to antimicrobial agents," which are diagnostic activities. It aids in determining the appropriate treatment by identifying how effective certain antimicrobial agents are against specific microorganisms.
No
The device description clearly outlines physical components (VITEK 2 AST Cards, VITEK 2 and VITEK 2 Compact Systems) and a physical process (diluting bacterial isolates, filling and sealing cards, incubation). While software is involved in monitoring and reporting, the core functionality relies on hardware and physical consumables.
Based on the provided text, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is "designed for antimicrobial susceptibility testing" and is a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents." This clearly indicates testing performed outside of the body.
- Device Description: The description details the process of testing bacterial isolates diluted in saline and placed into a card containing antimicrobial medium. This is a classic in vitro testing methodology.
- Performance Studies: The performance studies compare the device's performance with the "CLSI broth microdilution reference method," which is a standard in vitro diagnostic technique.
The core function of the device is to test the susceptibility of bacterial isolates to antimicrobial agents in vitro (outside of a living organism), which is the definition of an IVD.
N/A
Intended Use / Indications for Use
VITEK® 2 Gram Negative Levofloxacin is designed for antimicrobial susceptibility testing of Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens, Acinetobacter baumannii, Acinetobacter Iwoffi, Citrobacter koseri, Citrobacter freundii, Enterobacter aerogenes, Enterobacter sakazakii, Klebsiella oxytoca, Morganella morganii, Pantoea agglomerans, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Pseudomonas fluorescens. VITEK 2 Gram Negative Levofloxacin is a quantitative test. It 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.
The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 and VITEK® 2 Compact Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gramnegative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.
Product codes
LON
Device Description
VITEK® 2 Gram Negative Levofloxacin is designed for antimicrobial susceptibility testing of Enterpbacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa. Serratia marcescens. Acinetobacter baumannii, Acinetobacter twoffi, Citrobacter koseri, Čitrobacter freundii, Enterobacter aerogenes, Enterobacter sakazakii, Klebsiella oxytoca, Morqanella morqanii, Pantoea agglomerans, Proteus vulgaris, Providencia rettgeri, Providencia stuartii. Pseudomonas fluorescens. It 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. The antimicrobial presented in VITEK 2 AST Cards is in concentrations equivalent by efficacy to standard method concentrations in mog/m!. The VITEK 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.
The bacterial isolate to be tested is diluted to a standardized concentration in 0.45% 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 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 MC value along with the interpretive category result for each antibiotic 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
Not Found
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 and stock challenge strains. The external evaluations were designed to confirm the acceptability of VITEK 2 Gram Negative Levofloxacin by comparing its performance with the CLSI broth microdilution reference method. The data is representative of performance on both the VITEK 2 and VITEK 2 Compact instrument platforms, as evidenced in the AST equivalency study presented in the VITEK 2 Compact 510(k), K050002.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
VITEK 2 Gram Negative Levofloxacin 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 Feb. 5, 2003. VITEK 2 Gram Negative Levofloxacin demonstrated acceptable performance of 95,8% overall Category Agreement. Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
95,8% overall Category Agreement
Predicate Device(s)
VITEK 2 Gram Negative Ertapenem (K041982)
Reference Device(s)
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.”
0
Image /page/0/Picture/1 description: The image shows the logo for bioMérieux. The logo consists of the company name in a stylized font, with a graphic above it. The graphic is a black circle with lines emanating from it, and a curved line extending above and below the circle.
510(k) SUMMARY
: 1 : 1 : 10 :
VITEK® 2 Gram Negative Levofloxacin
510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Jolyn Tenilado |
| Senior Regulatory Affairs Specialist | |
| Phone Number: | 314-731-8386 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | July 20, 2007 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® 2 Gram Negative Levofloxacin (≤ 0.12 - ≥ 8 |
| µg/ml) | |
| Classification Name: | Fully Automated Short-Term Incubation Cycle |
| Antimicrobial Susceptibility Device, 21 CFR 866.1645 | |
| Common Name: | VITEK 2 AST-GN Levofloxacin |
| C. Predicate Device: | |
| D. 510(k) Summary: | VITEK 2 Gram Negative Ertapenem (K041982). |
VITEK® 2 Gram Negative Levofloxacin is designed for antimicrobial susceptibility testing of Enterpbacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa. Serratia marcescens. Acinetobacter baumannii, Acinetobacter twoffi, Citrobacter koseri, Čitrobacter freundii, Enterobacter aerogenes, Enterobacter sakazakii, Klebsiella oxytoca, Morqanella morqanii, Pantoea agglomerans, Proteus vulgaris, Providencia rettgeri, Providencia stuartii. Pseudomonas fluorescens. It 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. The antimicrobial presented in VITEK 2 AST Cards is in concentrations equivalent by efficacy to standard method concentrations in mog/m!. The VITEK 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.
The bacterial isolate to be tested is diluted to a standardized concentration in 0.45% 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 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 MC value along with the interpretive category result for each antibiotic contained on the card.
bioMérieux, Inc.
1
VITEK 2 Gram Negative Levofloxacin 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 Feb. 5, 2003 .*
The Premarket Notification (510[k]) presents data in support of VITEK 2 Gram Negative Levofloxacin. An external evaluation was conducted with fresh and stock clinical isolates and stock challenge strains. The external evaluations were designed to confirm the acceptability of VITEK 2 Gram Negative Levofloxacin by comparing its performance with the CLSI broth microdilution reference method. The data is representative of performance on both the VITEK 2 and VITEK 2 Compact instrument platforms, as evidenced in the AST equivalency study presented in the VITEK 2 Compact 510(k), K050002. VITEK 2 Gram Negative Levofloxacin demonstrated acceptable performance of 95,8% overall Category Agreement. Reproducibility and Quality Control demonstrated acceptable results.
*Note: This device clinical trial was initiated prior to the March 5, 2007 issuance of the revised guidance, which is why the older guidance document is cited.
2
Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 1 2 2007
Ms. Joyln Tenllado Senior Regulatory Affairs Specialist bioMérieux, Inc. 595 Anglum Road Hazelwood, MO 63042
K072038 Re: Trade/Device Name: VITEK® 2 Gram Negative Levofloxacin (≤0.12 - ≥8μg/ml) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility Devices Regulatory Class: Class II Product Code: LON Dated: July 20, 2007 Received: July 25, 2007
Dear Ms. Tenllando:
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 or clossified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that clannt 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publiah 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 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); and good manufacturing practice requirements as et freth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sally attaym
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K072038 510(k) Number (if known):_
Device Name: VITEK® 2 Gram Negative Levofloxacin (≤ 0.12 – ≥ 8 µg/ml)
Indications For Use:
VITEK® 2 Gram Negative Levofloxacin is designed for antimicrobial susceptibility testing of Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens, Acinetobacter baumannii, Acinetobacter Iwoffi, Citrobacter koseri, Citrobacter freundii, Enterobacter aerogenes, Enterobacter sakazakii, Klebsiella oxytoca, Morganella morganii, Pantoea agglomerans, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Pseudomonas fluorescens. VITEK 2 Gram Negative Levofloxacin is a quantitative test. It 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.
The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 and VITEK® 2 Compact Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gramnegative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.
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)
Rourrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) vision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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510(k)_14072038
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