(57 days)
N50510/S120
Not Found
No
The description focuses on a traditional microdilution method and automated reading of growth, with no mention of AI or ML algorithms for interpretation or analysis.
No
The device is described as a "laboratory aid" for determining in vitro susceptibility to antimicrobial agents, indicating it is used for diagnostic testing in a lab setting, not for direct treatment of a patient.
Yes
The device aids in determining the in vitro susceptibility of bacteria to antimicrobial agents, providing MIC values and interpretive categories, which are used to guide treatment decisions. This process fits the definition of diagnostic testing by identifying an attribute of a disease-causing agent to inform medical action.
No
The device description clearly outlines physical components (AST Cards, VITEK 2 System) and a process involving rehydrating media, incubation, and reading growth, indicating it is a hardware-based system with associated software, not a software-only device.
Yes, this 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 directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, treatment, or prevention of disease.
- Device Description: The description details how the device tests bacterial isolates in a laboratory setting using a microdilution methodology. This process is performed outside of the living organism (in vitro).
- Performance Studies: The performance studies compare the device's results to a reference method for determining antimicrobial susceptibility, which is a key function of an IVD.
- Predicate Device: The mention of a predicate device (VITEK 2 Gram Negative Susceptibility Test) further confirms its classification as an IVD, as predicate devices are used to demonstrate substantial equivalence for regulatory purposes for similar IVD devices.
- Intended User/Care Setting: The intended user is a "laboratory aid," indicating use in a clinical laboratory setting, which is typical for IVDs.
Therefore, based on the provided information, the VITEK® 2 Gram Negative Gatifloxacin is clearly an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VITEK® 2 Gram Negative Gatifloxacin is designed for antimicrobial susceptibility testing of Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Acinetobacter lwoffii, Citrobacter koseri, C. freundii, Enterobacter aerogenes, E. cloacae, Klebsiella oxytoca, Morganella morganii, and Proteus vulgaris. 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 (comma separated list FDA assigned to the subject device)
LON
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 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
Laboratory
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 Gatifloxacin 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 Neqative Gatifloxacin 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 Gatifloxacin demonstrated acceptable performance of 99.7% 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: 99.7%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
N50510/S120
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 = 4 2003
Image /page/0/Picture/2 description: The image shows the logo for bioMerieux. The logo consists of a stylized image of a cell or sphere that is half black and half white with lines. Below the image is the company name, "BIOMERIEUX" in a stylized font.
510(k) SUMMARY
VITEK® 2 Gram Negative Gatifloxacin
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 3, 2003 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® 2 Gram Negative Gatifloxacin |
| Classification Name: | Fully Automated Short-Term Incubation Cycle |
| Antimicrobial Susceptibility Device, | |
| 21 CFR 866.1645 | |
| Common Name: | VITEK 2 AST-GN Gatifloxacin |
| C. Predicate Device: | VITEK 2 Gram Negative Susceptibility Test for |
| Cefpodoxime (N50510/S120) |
D. 510(k) Summary:
VITEK® 2 Gram Negative Gatifloxacin is designed for antimicrobial susceptibility testing of Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Acinetobacter Iwoffii, Citrobacter koseri, C. freundii, Enterobacter aerogenes, E. cloacae, Klebsiella oxytoca, Morganella morganii, and Proteus vulgaris. 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 mca/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 Neqative Gatifloxacin 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 Gatifloxacin. 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 Gatifloxacin by comparing its performance with the NCCLS agar dilution reference method. VITEK 2 Gram Negative Gatifloxacin demonstrated acceptable performance of 99.7% overall Essential Agreement when compared to the agar dilution reference method. Reproducibility and Quality Control demonstrated acceptable results.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white 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 perimeter. In the center of the seal is a stylized image of an eagle with three lines extending from its head.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV - 4 2003
Ms. Nancy Weaver Staff Regulatory Affairs Specialist Biomerieux, Inc 595 Anglum Road Hazelwood, MO 63042-2320
Re: K032788 Trade/Device Name: VITEK® 2 Gram Negative Gatifloxacin (1-8 µg/ml) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully automated short-term incubation cycle antimicrobial susceptibility system Regulatory Class: Class II Product Code: LON Dated: September 3, 2003 Received: September 8, 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).
3
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). 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 (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
4
Indications for Use Statement
KO32788 510(k) Number (if known):
Device Name: VITEK® 2 Gram Negative Gatifloxacin (1 - 8 µg/ml)
Indications for Use:
VITEK® 2 Gram Negative Gatifloxacin is designed for antimicrobial susceptibility testing of Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Acinetobacter lwoffii, Citrobacter koseri, C. freundii, Enterobacter aerogenes, E. cloacae, Klebsiella oxytoca, Morganella morganii, and Proteus vulgaris. 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)
Fea Ott
Division Sign-Off
11/4/03
Office of In Vitro Diagnostic Device Evaluation and Safety
prescription use only.
K632788 510(k).