(68 days)
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 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.
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.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document mentions an overall "Category Agreement" as the key performance metric. It doesn't explicitly state a pre-defined acceptance criterion as a numerical threshold, but implies that 97.7% was acceptable.
| Acceptance Criteria (Stated) | Reported Device Performance |
|---|---|
| Acceptable overall Category Agreement | 97.7% overall Category Agreement (when compared to the NCCLS reference method) |
2. Sample Size and Data Provenance
The document states:
- Sample Size (Test Set): Not explicitly stated with a specific number. It mentions tests for "fresh and stock clinical isolates and stock challenge strains."
- Data Provenance: Not explicitly stated (e.g., country of origin). The testing included "clinical isolates" and "stock challenge strains," suggesting a mix of real-world and controlled laboratory samples. The study involved "external evaluations," but the location of these evaluations is not specified.
- Retrospective/Prospective: Not explicitly stated. The phrase "fresh and stock clinical isolates" could suggest both retrospective (stock) and potentially prospective (fresh) collection, but it's not clear.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
4. Adjudication Method
- Adjudication Method: Not mentioned. The ground truth was established by the "NCCLS ESBL Disk Diffusion Confirmatory Test method," which is a laboratory reference method, implying a standard protocol rather than human expert adjudication in the traditional sense.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, this does not appear to be an MRMC comparative effectiveness study. The device is an automated in vitro diagnostic test, not an imaging interpretation or similar task where human readers would typically be involved in varying assistance levels. The comparison is between the automated system and a laboratory reference method.
6. Standalone Performance Study
- Standalone Performance: Yes, the study describes the standalone performance of the VITEK® 2 ESBL Test. It compares the automated system's results directly against the NCCLS ESBL Disk Diffusion Confirmatory Test method without human intervention in the interpretation process. The 97.7% overall Category Agreement represents this standalone performance.
7. Type of Ground Truth
- Type of Ground Truth: The ground truth was established using a laboratory reference method: the "NCCLS ESBL Disk Diffusion Confirmatory Test method." This is a standardized conventional microbiology technique.
8. Sample Size for Training Set
- Sample Size (Training Set): Not mentioned. The document describes the "VITEK 2 ESBL Test" and its performance, but does not provide details on the development or training of the VITEK 2 system's algorithms. It's possible that the "training" refers to internal validation during the device development that is not explicitly detailed in this summary, or that the system operates based on established thresholds rather than a machine learning model requiring a distinct training set.
9. How Ground Truth for Training Set Was Established
- How Ground Truth Was Established (Training Set): Not mentioned. As above, details regarding any training or developmental data for the VITEK® 2 system are not provided in this 510(k) summary.
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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 RoadHazelwood, MO 63042 |
| Contact Person: | Nancy WeaverStaff 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 CycleAntimicrobial 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.
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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.
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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).
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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). 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
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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
Page 1 of
§ 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.”