(61 days)
N50510/S120
Not Found
No
The description focuses on a traditional microdilution method and automated reading of growth, with no mention of AI/ML for interpretation or analysis.
No.
The device is described as a "laboratory aid" for antimicrobial susceptibility testing, which provides information about the in vitro susceptibility of bacteria to antibiotics. It does not directly provide therapy or treatment to a patient.
Yes
The VITEK 2 Gram Negative Moxifloxacin is designed for antimicrobial susceptibility testing, providing a laboratory aid in determining the in vitro susceptibility of specific bacteria to antimicrobial agents. This information informs treatment decisions, which is a key characteristic of a diagnostic device.
No
The device description clearly outlines physical components (AST Cards, VITEK 2 System) and a process involving rehydrating media, filling, sealing, and incubating cards, which are hardware-based functions. The software component is for monitoring growth and generating reports, but it is integral to a larger hardware system.
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" and is intended for use "as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents." This clearly indicates it is used to test samples in vitro (outside the body) to provide information about a patient's condition (in this case, the susceptibility of bacteria to antibiotics).
- Device Description: The description details how the device works by testing bacterial isolates in a laboratory setting using a miniaturized dilution technique. This is a typical method for in vitro diagnostic testing.
- Intended User / Care Setting: It is described as a "laboratory aid," further reinforcing its use in a clinical laboratory setting for diagnostic purposes.
- Performance Studies: The description of performance studies comparing the device to a reference method for determining susceptibility is consistent with the validation required for IVD devices.
The core function of the device is to analyze a biological sample (bacterial isolate) in vitro to provide information that aids in the diagnosis and treatment of a patient (by determining which antibiotics are likely to be effective). This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VITEK® 2 Gram Negative Moxifloxacin is designed for antimicrobial susceptibility testing of, Klebsiella pneumoniae, Citrobacter freundii, Enterobacter cloacae, Escherichia coli Klebsiella oxytoca and Proteus mirabilis. It is intended for use with the VITEK® 2 System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.
Product codes
LON
Device Description
The antimicrobial presented in VITEK 2 AST 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 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 automatically fills, seals and places the card into the incubator/reader. 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 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 Moxifloxacin by comparing its performance with the NCCLS agar dilution reference method.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
VITEK® 2 Gram Negative Moxifloxacin demonstrated substantially equivalent performance when compared with the NCCLS reference agar dilution method, as defined in the FDA DRAFT document "Guidance on Review Criteria for Assessment of Antimicrobial susceptibility Devices", dated March 8, 2000 and Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA. Issued Feb. 5, 2003.
VITEK 2 Gram Negative Moxifloxacin demonstrated acceptable performance of 98.7% overall Essential Agreement when compared to the agar dilution reference method. Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement: 98.7%
Predicate Device(s)
VITEK 2 Gram Negative Susceptibility Test for Cefpodoxime (N50510/S120)
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.”
0
NOV 1 2 2003
Image /page/0/Picture/2 description: The image shows the logo for bioMerieux. The logo consists of the company name "bioMerieux" in a stylized font, with a vertical line running through the middle of the text. Above the text is a circular graphic with a textured pattern on the left side and a solid black fill on the right.
510(k) SUMMARY
VITEK® 2 Gram Negative Moxifloxacin
510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. | |
|---|---|---|
| Address: | 595 Anglum Road | |
| Hazelwood, MO 63042 | ||
| Contact Person: | Nancy Weaver | |
| Staff Regulatory Affairs Specialist | ||
| Phone Number: | 314-731-8695 | |
| Fax Number: | 314-731-8689 | |
| Date of Preparation: | September 8, 2003 | |
| B. Device Name: | ||
| Formal/Trade Name: | VITEK® 2 Gram Negative Moxifloxacin (0.25 - 4.0 | |
| µg/ml) | ||
| Classification Name: | Fully Automated Short-Term Incubation Cycle | |
| Antimicrobial Susceptibility Device, | ||
| 21 CFR 866.1645 | ||
| Common Name: | VITEK 2 AST-GN Moxifloxacin | |
| C. Predicate Device: | VITEK 2 Gram Negative Susceptibility Test for | |
| Cefpodoxime (N50510/S120) |
D. 510(k) Summary:
VITEK® 2 Gram Negative Moxifloxacin is designed for antimicrobial susceptibility testing of, Klebsiella pneumoniae, Citrobacter freundii, Enterobacter cloacae, Escherichia coli Klebsiella oxytoca and Proteus mirabilis. It is intended for use with the VITEK® 2 System 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 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 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 automatically fills, seals and places the card into the incubator/reader. The VITEK 2 monitors the growth of each well in the card over a defined period of time (up
1
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 antibiotic contained on the card.
VITEK 2 Gram Negative Moxifloxacin demonstrated substantially equivalent performance when compared with the NCCLS reference agar dilution method, as defined in the FDA DRAFT document "Guidance on Review Criteria for Assessment of Antimicrobial susceptibility Devices", dated March 8, 2000 and 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 Moxifloxacin. 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 Moxifloxacin by comparing its performance with the NCCLS agar dilution reference method. VITEK 2 Gram Negative Moxifloxacin demonstrated acceptable performance of 98.7% overall Essential Agreement when compared to the agar dilution reference method. Reproducibility and Quality Control demonstrated acceptable results.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 1 2 2003
Ms. Nancy Weaver Staff Regulatory Affairs Specialist BioMérieux, Inc. 595 Anglum Road Hazelwood, MO 63042-2320
Re: K032861
Trade/Device Name: VITEK 2® Gram Negative Moxifloxacin (0.25-4 ug/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: September 8, 2003 Received: September 12, 2003
Dear Ms. Weaver:
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.
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 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K032861
Device Name: VITEK 2° Gram Negative Moxifloxacin (0.25 - 4 µg/ml)
Indications for Use:
The VITEK 2 Gram Negative Moxifloxacin is designed for antimicrobial susceptibility testing of Klebsiella pneumoniae, Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca and Proteus mirabilis. It is intended for use with the VITEK 2 System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K032861
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