(38 days)
No
The description focuses on a miniaturized doubling dilution technique for determining minimum inhibitory concentration, which is a standard laboratory method, and there is no mention of AI or ML in the text.
No
This device is for in vitro susceptibility testing in a laboratory setting, not for direct treatment or amelioration of a disease.
Yes
Explanation: The device is used for "antimicrobial susceptibility testing" to determine "in vitro susceptibility to antimicrobial agents". This process involves identifying the effectiveness of antibiotics against specific microorganisms, which is a diagnostic function to inform treatment decisions.
No
The device description explicitly mentions "VITEK GNS Cards" which are described as "miniturized versions of the doubling dilution technique for determining the minimum in hilitory concentration (MIC) microdilution methodology." This indicates a physical component (the cards) is integral to the device's function, making it a hardware-based system with potentially 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 for "in vitro susceptibility testing of isolated colonies" and "a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents." This clearly indicates it is used to test samples outside of the body to provide information for diagnosis or treatment.
- Device Description: The description reinforces its use for "antimicrobial susceptibility testing" and describes it as a "miniaturized version of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology," which are standard in vitro diagnostic techniques.
- Care Setting: The intended user is a "laboratory," which is a typical setting for IVD testing.
The core function of the device is to analyze a biological sample (isolated bacterial colonies) in vitro to determine its susceptibility to antimicrobial agents, providing information that aids in clinical decision-making. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VITEK® Gram Negative Susceptibility Test is intended to be used with the VITEK® System 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 agalactiae, and S. pneumoniae. VITEK® Gram Negative Ertapenem is designed for antimicrobial susceptibility testing of Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii, Citrobacter koseri, Enterobacter aerogenes, Enterobacter cloacae, Klebsiella oxytoca (excluding ESBL producing strains), Morganella morganii, Proteus mirabilis, Proteus vulgaris and Serratia marcescens. VITEK Gram Negative Ertapenem is for qualitative testing only. 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 Ertapenem is designed for antimicrobial susceptibility testing of Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii, Citrobacter koseri, Enterobacter aerogenes, Enterobacter cloacae, Klebsiella oxytoca (excluding ESBL producing strains), Morganella morganii, Proteus mirabilis, Proteus vulgaris and Serratia marcescens. It is intended for use with the VITEK® System as a laboratory and in the determination of in vitro susceptibility to antimicrobial agents. The antimicry ial presented in VITEK GNS Cards is in concentrations equivalent by efficacy to atandard method concentrations in mcg/ml. The VITEK GNS Cards are essentially miniturized versions of the doubling dilution technique for determining the minimum in hilitory concentration (MIC) microdilution methodology.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
An external evaluation was conducted with fresh and stock clinical isalates and stock challenge strains. The external evaluations were designed to confirm the acceptability of VITEK Gram Negative Ertapenem 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 Ertapenem demonstrated substantially equivalent performance when compared with the NCCLS reference agar dilution 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 Gram Negative Ertapenem demonstrated acceptable performance of 98.7% overall Category Agreement when compared to the agar dilution reference method. Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
98.7% overall Category Agreement
Predicate Device(s)
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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DEC 3 0 2004
Image /page/0/Picture/2 description: The image shows the logo for bioMérieux. The logo consists of a stylized globe with one half black and the other half white with horizontal lines. Below the globe is the company name, "BIOMÉRIEUX" in a simple sans-serif font.
510(k) SUMMARY
VITEK® Gram Negative Ertapenem
510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Jolyn Tenllado |
| Regulatory Affairs Specialist | |
| Phone Number: | 314-731-8386 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | November 17, 2004 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® Gram Negative Ertapenem (≤0.5 – ≥8 |
| $µg/ml$ ) | |
| Classification Name: | Fully Automated Short-Term Incubation Cycle |
| Antimicrobial Susceptibility Device, | |
| 21 CFR 866.1645 | |
| Common Name: | VITEK GNS Ertapenem |
| C. Predicate Device: | VITEK Gram Negative Susceptibility (GNS) Card |
| for Gatifloxacin (K032711) |
D. 510(k) Summary:
VITEK® Gram Negative Ertapenem is designed for antimicrobial susceptibility testing of Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii, Citrobacter koseri, Enterobacter aerogenes, Enterobacter cloacae, Klebsiella oxytoca (excluding ESBL producing strains), Morganella morganii, Proteus mirabilis, Proteus vulgaris and Serratia marcescens. It is intended for use with the VITEK® System as a laboratory and in the determination of in vitro susceptibility to antimicrobial agents. The antimicry ial presented in VITEK GNS Cards is in concentrations equivalent by efficacy to atandard method concentrations in mcg/ml. The VITEK GNS Cards are essentially miniturized versions of the doubling dilution technique for determining the minimum in hilitory concentration (MIC) microdilution methodology.
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calculated once a predetermined growth threshold is reached, and a report is generated that contains the MIC result and the interpretive category result.
VITEK Gram Negative Ertapenem demonstrated substantially equivalent performance when compared with the NCCLS reference agar dilution 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 Gram Negative Ertapenem. An external evaluation was conducted with fresh and stock clinical isalates and stock challenge strains. The external evaluations were designed to confirm the acceptability of VITEK Gram Negative Ertapenem by comparing its performance with the NCCLS agar dilution reference method. VITEK Gram Negative Ertapenem demonstrated acceptable performance of 98.7% overall Category Agreement when compared to the agar dilution reference method. Reproducibility and Quality Control demonstrated acceptable results.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 3 0 2004
Ms. Jolyn Tenllado Regulatory Affairs Specialist BioMérieux, Inc. 595 Anglum Road Hazelwood, MO 63042-2320
Re: K043230
Trade/Device Name: VITEK® Gram Negative Ertapenem (≤0.5 ->>8 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: November 17, 2004 Received: November 22, 2004
Dear Ms. Tenllado:
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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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,
Saartys
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
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Indications for Use
510(k) Number (if known): K043230
Device Name: VITEK® Gram Negative Ertapenem (≤ 0.5 – ≥ 8 µg/ml)
Indications For Use:
The VITEK® Gram Negative Susceptibility Test is intended to be used with the VITEK® System 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 agalactiae, and S. pneumoniae. VITEK® Gram Negative Ertapenem is designed for antimicrobial susceptibility testing of Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii, Citrobacter koseri, Enterobacter aerogenes, Enterobacter cloacae, Klebsiella oxytoca (excluding ESBL producing strains), Morganella morganii, Proteus mirabilis, Proteus vulgaris and Serratia marcescens. VITEK Gram Negative Ertapenem is for qualitative testing only. It is intended for use with the VITEK System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.
Prescription Use × (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)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Vor, ass
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluanon and Safety
KO43230 510(k)_