(59 days)
N50510/S073
Not Found
No
The description focuses on a miniaturized doubling dilution technique and automated monitoring of bacterial growth, with no mention of AI or ML.
No
The device is described as a "laboratory aid" for in vitro susceptibility testing of antimicrobial agents, not for direct treatment or diagnosis of patients.
Yes
The device aids in the determination of in vitro susceptibility to antimicrobial agents, which is a key step in diagnosing and guiding treatment for bacterial infections.
No
The device description clearly states that the VITEK GNS Cards are physical cards containing antimicrobial medium and that the VITEK system is a physical instrument that fills, seals, incubates, and reads these cards. This involves significant hardware components beyond just software.
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 "intended for use with the VITEK® System 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 (susceptibility to antibiotics).
- Device Description: The description details how the device works by testing bacterial isolates in a laboratory setting using a miniaturized microdilution technique. This is a standard method for in vitro diagnostic testing in microbiology.
- Intended User / Care Setting: The intended user is described as a "laboratory aid," further reinforcing its use in a clinical laboratory setting for diagnostic purposes.
- Performance Studies: The performance studies compare the device's performance to a reference method (NCCLS agar dilution reference method), which is typical for validating the accuracy of an in vitro diagnostic test.
All these factors align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The VITEK® Gram Negative Gatifloxacin is designed for antimicrobial susceptibility testing of Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Acinetobacter lwoffii, Citrobacter koseri, Citrobacter freundii, Enterobacter aerogenes, Enterobacter cloacae, Klebsiella oxytoca, Morganella morganii and Proteus vulgaris. It is intended for use with the VITEK® System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.
Product codes
LON
Device Description
VITEK® Gram Negative Gatifloxacin is designed for antimicrobial susceptibility testing of Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis. Acinetobacter Iwoffii, Citrobacter koseri, Citrobacter freundii, Enterobacter aerogenes, Enterobacter cloacae, Klebsiella oxytoca, Morganella morganii and Proteus vulgaris. It is intended for use with the VITEK® System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. The antimicrobial presented in VITEK GNS Card is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml. The VITEK GNS Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) my 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 automatically fills, seals and places the card into the incubator/reader. The VITEK monitors the growth of each well in the card over a defined period of time (up to 15 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 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 and stock challenge strains. The external evaluations were designed to confirm the acceptability of VITEK 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 Gram Negative Gatifloxacin demonstrated substantially equivalent performance when compared with the NCCLS reference agar dilution method, as defined in the Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA, February 5, 2003.
The Premarket Notification (510[k]) presents data in support of VITEK 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 Gram Negative Gatifloxacin by comparing its performance with the NCCLS agar dilution reference method. VITEK Gram Negative Gatifloxacin demonstrated acceptable performance of 97.9% 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: 97.9%
Predicate Device(s)
N50510/S073
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
OCT 3 1 2003
Image /page/0/Picture/2 description: The image shows the logo for bioMerieux. The logo consists of a stylized image of a sphere that is bisected by a vertical line. The text "BIOMERIEUX" is written in all capital letters below the sphere.
510(k) SUMMARY
VITEK® 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: | August 29, 2003 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® Gram Negative Gatifloxacin (1.5 - 10 µg/ml) |
| Classification Name: | Fully Automated Short-Term Incubation Cycle |
| Antimicrobial Susceptibility Device, 21 CFR 866.1645 | |
| Common Name: | VITEK GNS Gatifloxacin |
| C. Predicate Device: | VITEK® Gram Negative Susceptibility Card - |
| Cefpodoxime (N50510/S073) |
D. 510(k) Summary:
B
C
VITEK® Gram Negative Gatifloxacin is designed for antimicrobial susceptibility testing of Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis. Acinetobacter Iwoffii, Citrobacter koseri, Citrobacter freundii, Enterobacter aerogenes, Enterobacter cloacae, Klebsiella oxytoca, Morganella morganii and Proteus vulgaris. It is intended for use with the VITEK® System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. The antimicrobial presented in VITEK GNS Card is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml. The VITEK GNS Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) my 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 automatically fills, seals and places the card into the incubator/reader. The VITEK monitors the growth of each well in the card over a defined period of time (up to 15 hours). At the
1
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 Gram Negative Gatifloxacin demonstrated substantially equivalent performance when compared with the NCCLS reference agar dilution method, as defined in the Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA, February 5, 2003.
The Premarket Notification (510[k]) presents data in support of VITEK 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 Gram Negative Gatifloxacin by comparing its performance with the NCCLS agar dilution reference method. VITEK Gram Negative Gatifloxacin demonstrated acceptable performance of 97.9% 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 shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its body and wings. The eagle is oriented towards the upper right of the image. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
OCT 3 1 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Nancy Weaver Staff Regulatory Affairs Specialist BioMerieux, Inc. 595 Anglum Road Hazelwood, MO 63042-2320
Re: K032711
Trade/Device Name: VITEK® Gram Negative Gatifloxacin (1.5-10 µg/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: August 29, 2003 Received: September 2, 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. Iisting 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). 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
4
Indications for Use Statement
KD32711 510(k) Number (if known): _
Device Name: VITEK® Gram Negative Gatifloxacin (1.5 - 10 µg/ml)
Indications for Use:
The VITEK® Gram Negative Gatifloxacin is designed for antimicrobial susceptibility testing of Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Acinetobacter lwoffii, Citrobacter koseri, Citrobacter freundii, Enterobacter aerogenes, Enterobacter cloacae, Klebsiella oxytoca, Morganella morganii and Proteus vulgaris. It is intended for use with the VITEK® 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)
Freddie tur Poole
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K032711
- For Prescription Use Only