(50 days)
Not Found
No
The description focuses on a traditional microdilution technique for antimicrobial susceptibility testing and does not mention any AI or ML components.
No.
The device is described as a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents," indicating it is used for diagnostic testing and not for direct therapeutic intervention.
Yes
The device aids in determining in vitro susceptibility of microorganisms to antimicrobial agents, providing quantitative test results (MIC value and interpretive category), which are used to guide treatment decisions, thus performing a diagnostic function.
No
The device description clearly outlines a physical card with wells containing culture media and antibiotics, which is processed by a hardware system (VITEK 2 or VITEK 2 Compact Systems). This indicates a hardware component is integral to the device's function.
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 of gram-negative microorganisms and is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents." The phrase "in vitro susceptibility" is a key indicator of an IVD.
- Device Description: The description details a test performed on a sample (bacterial isolate) outside of the body ("in vitro") using a specific reagent card and system to determine the susceptibility of the microorganism to an antimicrobial agent. This aligns with the definition of an IVD.
- Laboratory Aid: The intended user is described as a "laboratory aid," further reinforcing that the testing is performed in a laboratory setting.
- Performance Data: The inclusion of performance data like EA (Essential Agreement) and CA (Category Agreement) are standard metrics for evaluating the performance of IVD devices used in susceptibility testing.
- Predicate Device: The mention of a predicate device (K082346; VITEK 2 Gram Negative Doripenem) which is also an antimicrobial susceptibility test, strongly suggests that this device falls under the same regulatory category as an IVD.
Based on the provided information, the VITEK® 2 Gram Negative Meropenem is clearly designed and intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
VITEK® 2 Gram Negative Meropenem is designed for antimicrobial susceptibility testing of gramnegative microorganisms and is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 Gram Negative Meropenem is a quantitative test. Meropenem has been shown to be active against most isolates of the following microorganisms listed below according to the FDA label for the antimicrobial.
Active in vitro and in clinical infections:
Escherichia coli Klebsiella pneumoniae, Pseudomonas aeruginosa, Proteus mirabilis, Acinetobacter species Aeromonas hydrophila
Citrobacter diversus Citrobacter freundii Enterobacter cloacae Hafnia alvei Klebsiella oxytoca Morganella morganii
Pasteurella multocida Proteus vulgaris Salmonella species Serratia marcescens Shigella species
The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 and VITEK® 2 Compact Systems 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.
Product codes
LON
Device Description
The principle of the VITEK 2 AST cards is based on the microdilution minimum inhibitory concentration (MIC) technique reported by MacLowry and Marsh " and Gerlach (2). The VITEK 2 AST card is essentially a miniaturized, abbreviated and automated version of the doubling dilution technique (3)
Each VITEK 2 AST card contains 64 wells. A control well which contains only microbiological culture media is resident on all cards. The remaining wells contain premeasured portions of a specific antibiotic combined with culture media. The bacterial isolate to be tested is diluted to a standardized concentration with 0.45 -0.5% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK 2 System automatically fills, seals and places the card into the incubator/reader. The VITEK 2 Compact has a manual filling, sealing and loading operation. The VITEK 2 Systems monitor 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 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical studies were performed and demonstrate acceptable performance of VITEK 2 GN Meropenem.
Performance:
Clinical & Challenge Performance Data: EA = 97.6%, CA = 96.8%
Reproducibility: Best-case 99.6%, Worst-case 99.6%
Quality Control: > 20 tests in range
Meets Guidance Document Performance Requirements: Yes
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
EA = 97.6% (Essential Agreement)
CA = 96.8% (Category Agreement)
Reproducibility: Best-case 99.6%, Worst-case 99.6%
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.”
0
K09/899
chromID ™ MRSA Agar
Traditional 510(k) Submission
SECTION 2: EXECUTIVE SUMMARY
AUG 1 4 2009 -
Intended Use:
VITEK® 2 Gram Negative Meropenem is designed for antimicrobial susceptibility testing of gramnegative microorqanisms and is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 Gram Negative Meropenem is a quantitative test. Meropenem has been shown to be active against most isolates of the following microorganisms listed below according to the FDA label for the antimicrobial.
Active in vitro and in clinical infections:
Escherichia coli Klebsiella pneumoniae, Pseudomonas aeruginosa, Proteus mirabilis, Acinetobacter species Aeromonas hydrophila
Citrobacter diversus Citrobacter freundii Enterobacter cloacae Hafnia alvei Klebsiella oxytoca Morganella morganii
Pasteurella multocida Proteus vulgaris Salmonella species Serratia marcescens Shigella species
The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 and VITEK® 2 Compact Systems 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.
Device Description:
The principle of the VITEK 2 AST cards is based on the microdilution minimum inhibitory concentration (MIC) technique reported by MacLowry and Marsh " and Gerlach (2). The VITEK 2 AST card is essentially a miniaturized, abbreviated and automated version of the doubling dilution technique (3)
Each VITEK 2 AST card contains 64 wells. A control well which contains only microbiological culture media is resident on all cards. The remaining wells contain premeasured portions of a specific antibiotic combined with culture media. The bacterial isolate to be tested is diluted to a standardized concentration with 0.45 -0.5% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK 2 System automatically fills, seals and places the card into the incubator/reader. The VITEK 2 Compact has a manual filling, sealing and loading operation. The VITEK 2 Systems monitor 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.
The MIC ranges, interpretive criteria and equivalent concentrations are as follows:
| VITEK 2 AST-GN
Meropenem | Equivalent Standard
Method Concentration
by Efficacy in µg/ml | MIC Ranges and FDA Interpretive
Criteria.
MIC in µg/ml * | | |
|-------------------------------------------------------------------------|---------------------------------------------------------------------|----------------------------------------------------------------|---|------|
| | | S | I | R |
| Enterobacteriaceae,
Acinetobacter spp.,
Pseudomonas
aeruginosa | 0.5, 2, 6, 12 | ≤ 0.25 - 4 | 8 | ≥ 16 |
- FDA category interpretation in bold-faced type.
1
Image /page/1/Picture/0 description: The image contains the word "BIOMÉRIEUX" in a bold, sans-serif font. The letters are capitalized and evenly spaced. Above the text, there is a black circle with some lines coming out of it, possibly part of a logo.
Traditional 510(k) Submission
- S = Susceptible: Attainable levels in blood or tissue on usual usage, including oral administration when applicable.
- I = Intermediate: "The "Intermediate" category implies clinical efficacy in body sites where the drugs are physiologically concentrated (e.g., quinolones and B-lactams in urine), or when a higher than normal dosage of drug can be used (e.g., B-lactams). The "Intermediate" category also includes a "buffer zone" which should prevent small, uncontrolled, technical factors from causing maior discrepancies in interpretations, especially for drugs with narrow pharmacotoxicity margins."(4)
- R = Resistant to usually achievable systemic concentrations.
Device Comparison Table:
The similarities and differences of the VITEK 2 Gram Negative Meropenem when compared to the predicate device, VITEK 2 Gram Negative Doripenem (K082346), are described in the following table.
| Item | Device:
VITEK 2 Gram Negative
Meropenem | Predicate:
VITEK 2 Gram Negative Doripenem
(K082346) |
|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | VITEK® 2 Gram Negative Meropenem is designed for antimicrobial susceptibility testing of Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Proteus mirabilis, Acinetobacter spp., Aeromonas hydrophila, Citrobacter diversus, Citrobacter freundii, Enterobacter cloacae, Hafnia alvei, Klebsiella oxytoca, Morganella morganii, Pasteurella multocida, Proteus vulgaris, Salmonella species, Serratia marcescens, and Shigella species. VITEK 2 Gram Negative Meropenem is a quantitative test. It is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. | VITEK® 2 Gram Negative Doripenem is designed for antimicrobial susceptibility testing of Acinetobacter baumannii, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Citrobacter freundii, Enterobacter cloacae, Enterobacter aerogenes, Klebsiella oxytoca, Serratia marcescens. VITEK 2 Gram Negative Doripenem is a quantitative test. It is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. |
| Test method | Automated Gram negative antimicrobial susceptibility test for use with the VITEK 2 and VITEK 2 Compact Systems (VITEK 2 Systems) to determine the in vitro susceptibility of gram-negative bacilli. | Same |
| Inoculum | Saline suspension of bacteria | Same |
2
chromID™ MRSA Agar
Traditional 510(k) Submission
| Item | Device:
VITEK 2 Gram Negative
Meropenem | Predicate:
VITEK 2 Gram Negative Doripenem
(K082346) |
|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Differences | | |
| Antimicrobial | Concentrations of the
antimicrobial in the test wells of
the VITEK 2 AST card and the
analysis algorithms are unique
for each specific antimicrobial. | Same |
Discussion:
віом É
RIE U X
Both devices have similar Intended Use statements. The technological characteristics are similar but not identical. Both devices are designed for susceptibility testing of gram-negative bacilli on the VITEK 2 Systems and their technological characteristics are similar. The tests use the same base broth and are intended for use on the same VITEK 2 gram negative AST cards. The difference between the new device and the predicate device is related to the antibiotic. Concentrations of the antibiotic in the test wells and the analysis algorithms are unique for each specific antibiotic. In all other respects the two devices are identical.
The safety and effectiveness of VITEK 2 GN Meropenem is not impacted by the technology differences. Clinical studies were performed and demonstrate acceptable performance of VITEK 2 GN Meropenem. Performance is described in the following table.
| Item | Device:
VITEK 2 Gram Negative
Meropenem | Predicate:
VITEK 2 Gram Negative
Doripenem (K082346) |
|-----------------------------------------------------|-----------------------------------------------|------------------------------------------------------------|
| Performance | | |
| Clinical & Challenge
Performance Data | EA = 97.6%
CA = 96.8% | EA = 97.4%
CA = 97.9% |
| Reproducibility | Best-case 99.6%
Worst-case 99.6% | Best-case 99.2%
Worst-case 90.6% |
| Quality Control | > 20 tests in range | > 20 tests in range |
| Meets Guidance Document
Performance Requirements | Yes | Yes |
Conclusion:
The analytical and clinical performance data presented in this submission support a substantial equivalence decision. The VITEK 2 Gram Negative Meropenem is substantially equivalent to the VITEK 2 Gram Negative Doripenem (K082346).
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human figures, possibly representing health, well-being, and human services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Ms. Nancy Weaver Associate Director, Regulatory Affairs bioMérieux 595 Anglum Road Hazelwood, MO 63042
AUG 1 4 2009
Re: K091899
Trade/Device Name: VITEK® 2 Gram Negative Meropenem (≤ 0.25 - ≥ 16 µg/ml) Regulation Number: 21 CFR 866.1645 Regulation Name: Short-Term Antimicrobial Susceptibility Test System Regulatory Class: Class II Product Code: LON Dated: June 22, 2009 Received: June 25, 2009
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 class II (Special Controls), 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
4
Page 2 - Ms. Weaver
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sally a Hynson
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
5
Indications for Use
510(k) Number (if known):_ KDGI 899
Device Name: VITEK® 2 Gram Negative Meropenem· (≤ 0.25 - ≥ 16 µg/ml)
Indications For Use:
VITEK® 2 Gram Negative Meropenem is designed for antimicrobial susceptibility testing of gramnegative microorganisms and is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 Gram Negative Meropenem is a quantitative test. Meropenem has been shown to be active against most isolates of the following microorganisms listed below according to the FDA label for the antimicrobial.
Active in vitro and in clinical infections:
Escherichia coli Klebsiella pneumoniae. Pseudomonas aeruginosa, Proteus mirabilis, Acinetobacter species Aeromonas hydrophila
Citrobacter diversus Citrobacter freundii Enterobacter cloacae Hafnia alvei Klebsiella oxytoca Morganella morganii
Pasteurella multocida Proteus vulgaris Salmonella species Serratia marcescens Shigella species
The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2
and VITEK® 2 Compact Systems for the automated quantitative or qualitative susce of isolated colonies for the most clinically significant aerobic gram-negative bacilli. Staphylococus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.
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)
Fueddi hi. Pedra
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) /K091899
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