(68 days)
N50510/S081
Not Found
No
The summary describes an automated system for antimicrobial susceptibility testing based on miniaturized microdilution. It mentions automated filling, sealing, incubation, and reading of growth, but there is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The performance evaluation compares the device to a standard reference method, not an AI/ML model.
No
The device is a laboratory aid for in vitro susceptibility testing of antimicrobial agents, not a device used to provide therapy to a patient.
Yes
The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended for "automated quantitative or qualitative susceptibility testing of isolated colonies" and is described as a "confirmatory test used to detect the presence of extended-spectrum beta-lactamases (ESBLs)". This directly relates to diagnosing the susceptibility of bacteria to antimicrobial agents, which is a diagnostic function.
No
The device description clearly outlines a system that includes physical components like cards containing antimicrobial media, a system for diluting and rehydrating the media, and an incubator/reader that monitors growth. While software is undoubtedly involved in processing the data and generating reports, the core functionality relies on physical components and biological processes.
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 "confirmatory test used to detect the presence of extended-spectrum beta-lactamases (ESBLs)". This involves testing biological samples (bacterial isolates) outside of the body to provide information for diagnosis or treatment.
- Device Description: The description details how the device interacts with a "bacterial isolate to be tested" and performs "automated quantitative or qualitative susceptibility testing". This is a hallmark of an in vitro diagnostic process.
- Intended User / Care Setting: The intended user is a "laboratory aid", which is where in vitro diagnostic testing is performed.
- Performance Studies: The performance studies compare the device's performance to a "NCCLS ESBL Disk Diffusion Confirmatory Test", which is a standard in vitro diagnostic method.
The entire description points to a device designed to analyze biological samples in a laboratory setting to provide diagnostic information, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 System for the automated quantitative or qualitative susceptibility testing of isolated colonies for most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae. The VITEK® 2 ESBL Test is a confirmatory test used to detect the presence of extended-spectrum beta-lactamases (ESBLs) in Escherichia coli, Klebsiella pneumoniae, and K. oxytoca. 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 VITEK 2 ESBL test contains the following antimicrobial concentrations:
Cefepime 1.0 µg/ml Cefotaxime 0.5 µg/ml Ceftazidime 0.5 uq/ml Cefepime/Clavulanic Acid 1.0 / 10 µg/ml Cefotaxime/Clavulanic Acid 0.5 / 4.0 µg/ml Ceftazidime/Clavulanic Acid 0.5 / 4.0 µg/ml
Product codes
LON
Device Description
The VITEK® 2 ESBL Test is a confirmatory test for the presence of extended-spectrum beta-lactamases (ESBLs) in Escherichia coli, Klebsiella pneumoniae, and K. oxytoca. 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 antimicrobials presented in VITEK 2 ESBL Test are in concentrations equivalent by efficacy to standard method concentrations in ug/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 VITEK 2 ESBL Test result.
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
The Premarket Notification (510[k]) presents data in support of VITEK 2 ESBL Test. An The Tremanon (Stockhoation (STS) with fresh and stock clinical isolates and stock challenge strains. The external evaluations were designed to confirm the acceptability of onaliong other the comparing its performance with the NCCLS ESBL Disk Diffusion Confirmatory Test.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
VITEK 2 ESBL Test demonstrated substantially equivalent performance when compared with the NCCLS ESBL Disk Diffusion Confirmatory Test method.
The VITEK 2 ESBL Test demonstrated acceptable performance of 97.7% overall Category Agreement when compared to the NCCLS reference method. Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
97.7% overall Category Agreement
Predicate Device(s)
VITEK ESBL Test (N50510/S081)
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
JUN = 8 2004
Image /page/0/Picture/2 description: The image contains the logo of bioMérieux, a French multinational biotechnology company. The logo consists of the text "MÉRIEUX" in a stylized font. Above the text is a graphic element, possibly representing a stylized cell or biological structure.
510(k) SUMMARY
VITEK® 2 ESBL Test
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: | March 31, 2004 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® 2 ESBL Test |
| Classification Name: | Fully Automated Short-Term Incubation Cycle |
| Antimicrobial Susceptibility Device, | |
| 21 CFR 866.1645 | |
| Common Name: | VITEK 2 ESBL Test |
| C. Predicate Device: | VITEK ESBL Test (N50510/S081) |
D. 510(k) Summary:
The VITEK® 2 ESBL Test is a confirmatory test for the presence of extended-spectrum beta-lactamases (ESBLs) in Escherichia coli, Klebsiella pneumoniae, and K. oxytoca. 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 antimicrobials presented in VITEK 2 ESBL Test are in concentrations equivalent by efficacy to standard method concentrations in ug/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 VITEK 2 ESBL Test result.
1
VITEK 2 ESBL Test demonstrated substantially equivalent performance when compared with the NCCLS ESBL Disk Diffusion Confirmatory Test method.
The Premarket Notification (510[k]) presents data in support of VITEK 2 ESBL Test. An The Tremanon (Stockhoation (STS) with fresh and stock clinical isolates and stock challenge strains. The external evaluations were designed to confirm the acceptability of onaliong other the comparing its performance with the NCCLS ESBL Disk Diffusion Confirmatory Test. The VITEK 2 ESBL Test demonstrated acceptable performance of 97.7% overall Category Agreement when compared to the NCCLS reference method. Reproducibility and Quality Control demonstrated acceptable results.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN - 8 2004
Ms. Nancy Weaver Staff Regulatory Affairs Specialist BioMérieux, Inc. 595 Anglum Road Hazelwood, MO 63042-2320
K040845 Re:
Trade/Device Name: VITEK® 2 ESBL Test 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: March 31, 2004 Received: April 1, 2004
Dear Ms. Weaver:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrebare) 75 the enactment date of the Medical Device Amendments, or to conninered pror to ria) 2011-12-12 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). and Cosmote Free (110) market the device, subject to the general controls provisions of the Act. The 1 ou may, uterest, maxims 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 your device is elabilitional controls. Existing major regulations affecting your device it may be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA can or loand in Ther announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean i lease of actived that i bring that your device complies with other requirements of the Act that I DA has made a acted regulations administered by other Federal agencies. You must or any I 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,
Saqartys
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
510(k) Number (if known): 长 0나08પડ
Device Name:
VITEK® 2 ESBL Test
Indications For Use:
The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 System for the automated quantitative or qualitative susceptibility testing of isolated colonies for most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae. The VITEK® 2 ESBL Test is a confirmatory test used to detect the presence of extended-spectrum beta-lactamases (ESBLs) in Escherichia coli, Klebsiella pneumoniae, and K. oxytoca. 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 VITEK 2 ESBL test contains the following antimicrobial concentrations:
Cefepime 1.0 µg/ml Cefotaxime 0.5 µg/ml Ceftazidime 0.5 uq/ml Cefepime/Clavulanic Acid 1.0 / 10 µg/ml Cefotaxime/Clavulanic Acid 0.5 / 4.0 µg/ml Ceftazidime/Clavulanic Acid 0.5 / 4.0 µg/ml
V 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)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k o r o d r s
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