(321 days)
Not Found
No
The description focuses on a miniaturized microdilution method and automated reading of growth, without mentioning AI or ML in the process of determining susceptibility or interpreting results.
No
The device is described as a "laboratory aid" for "in vitro susceptibility testing" to determine how effective antimicrobial agents are, which helps in guiding treatment rather than directly providing therapy.
Yes
The device is designed for antimicrobial susceptibility testing, which helps in determining the effectiveness of antimicrobial agents against specific microorganisms. This information is crucial for guiding treatment decisions, making it a diagnostic aid. The "Intended Use / Indications for Use" section explicitly states it is a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents."
No
The device description explicitly details physical components like "VITEK 2 AST Cards," "saline," and the "VITEK 2 System" or "VITEK 2 Compact" instruments, which are hardware. The process involves filling, sealing, and incubating these cards within the instrument. While software is undoubtedly involved in monitoring growth and generating reports, the core functionality relies on physical components and processes, not solely software.
Based on the provided text, the device is indeed an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The text explicitly states the device is "designed for antimicrobial susceptibility testing of Gram-negative bacilli" and is a "qualitative test 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 how the device works by testing bacterial isolates in a laboratory setting using miniaturized microdilution methodology. This process is performed outside of the living organism.
- Performance Studies: The performance studies compare the device's performance with a "CLSI broth microdilution reference method," which is a standard laboratory technique for in vitro testing.
- 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.
Therefore, all the provided information points to the VITEK® 2 Gram Negative Trimethoprim/sulfamethoxazole being an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VITEK® 2 Gram Negative Trimethoprim/sulfamethoxazole is designed for antimicrobial susceptibility testing of Gram-negative bacilli. VITEK 2 Gram Negative Trimethoprim/ sulfamethoxazole is a qualitative test 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. Trimethoprim/sulfamethoxazole has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial.
Active in vitro and in clinical infections
Escherichia coli (including susceptible enterotoxigenic strains implicated in traveler's diarrhea) Klebsiella species Proteus mirabilis Enterobacter species Shigella flexneri Morganella morganii Shigella sonnei Proteus vulgaris
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 the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, S. pneumoniae and clinically significant yeast.
Product codes (comma separated list FDA assigned to the subject device)
LON
Device Description
The antimicrobial presented in VITEK 2 AST Cards is in concentrations equivalent by efficacy to standard method concentrations in mcg/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 - 0 .50% 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 and sealing operation. 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 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
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 clinical isolates and stock challenge strains. The external evaluations were designed to confirm the acceptability of VITEK 2 Gram Negative SXT by comparing its performance with the CLSI broth microdilution reference method. The data is representative of performance on both the VITEK 2 and VITEK 2 Compact instrument platforms.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
VITEK 2 Gram Negative SXT demonstrated substantially equivalent performance when compared with the CLSI broth microdilution reference method, as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems: Guidance for Industry and FDA, Issued February 5, 2003.
VITEK 2 Gram Negative SXT demonstrated acceptable performance of 100% overall Category Agreement. Reproducibility and Quality Control demonstrated acceptable results using both the VITEK 2 and VITEK 2 Compact instrument systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
100% overall Category Agreement.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
VITEK 2 Gram Negative Meropenem K091899
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
KII0106
Image /page/0/Picture/1 description: The image shows the logo for bioMérieux. The logo consists of a stylized globe split into two halves, one with horizontal lines and the other solid black. A curved line passes vertically through the center of the globe. Below the globe, the text "BIOMÉRIEUX" is displayed in a stylized font.
NOV 3 0 2011
510(k) SUMMARY
VITEK® 2 Gram Negative Trimethoprim/sulfamethoxazole (SXT)
510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Jolyn Tenllado |
| Senior Manager, Regulatory Affairs | |
| Phone Number: | 314 -731-8386 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | December 21, 2010 |
| Device Name: | |
| Formal/Trade Name: | VITEK® 2 Gram Negative Trimethoprim/sulfamethoxazole |
| (≤ 1/19 - ≥ 16/304 µg/ml) | |
| Classification Name: | Fully Automated Short-Term Incubation Cycle Antimicrobial |
| Susceptibility Device, 21 CFR 866.1645 | |
| Common Name: | VITEK 2 AST-GN SXT |
| Predicate Device: | VITEK 2 Gram Negative Meropenem K091899 |
D. 510(k) Summary:
в.
C.
VITEK® 2 Gram Negative SXT 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. VITEK 2 Gram Negative SXT is a qualitative test. SXT has been shown to be active against the microorganisms listed below according to the FDA label for the antimicrobial.
Active in vitro and in clinical infections
Escherichia coli (including susceptible enterotoxigenic strains implicated in traveler's diarrhea) Klebsiella species
Enterobacter species Morganella morganii Proteus vulgaris
Proteus mirabilis Shigella flexneri Shigella sonnei
p. 264
1
The antimicrobial presented in VITEK 2 AST Cards is in concentrations equivalent by efficacy to standard method concentrations in mcg/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 - 0 .50% 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 and sealing operation. 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 cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic contained on the card.
VITEK 2 Gram Negative SXT demonstrated substantially equivalent performance when compared with the CLSI broth microdilution reference method, as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems: Guidance for Industry and FDA, Issued February 5, 2003.
The Premarket Notification [510(k)] presents data in support of VITEK 2 Gram Negative SXT. An external evaluation was conducted with fresh clinical isolates and stock challenge strains. The external evaluations were designed to confirm the acceptability of VITEK 2 Gram Negative SXT by comparing its performance with the CLSI broth microdilution reference method. The data is representative of performance on both the VITEK 2 and VITEK 2 Compact instrument platforms. VITEK 2 Gram Negative SXT demonstrated acceptable performance of 100% overall Category Agreement. Reproducibility and Quality Control demonstrated acceptable results using both the VITEK 2 and VITEK 2 Compact instrument systems.
2
10903 New Hampshire Avenue Silver Spring, MD 20993
NOV 3 0 2011
bioMérieux, Inc. c/o Jolyn Tenllado Senior Manager, Regulatory Affairs 595 Anglum Road Hazelwood, Missouri 63042-2320
Re: K110106
Trade/Device Name: VITEK® 2 Gram Negative Trimethoprim/sulfamethoxazole ( 16/304 ug/ml) Regulation Number: 21 CFR$ 866.1645 Regulation Name: Short-Term Antimicrobial Susceptibility Test System Regulatory Class: Class II Product Code: LON Dated: November 10, 2011 Received: November 14, 2011
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 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 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
3
Page 2 - Jolyn Tenllado
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 vours,
Scila Afta
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):__K // O/O6
Device Name: VITEK® 2 Gram Negative Trimethoprim/sulfamethoxazole ( 16/304 ug/ml)
Indications For Use:
VITEK® 2 Gram Negative Trimethoprim/sulfamethoxazole is designed for antimicrobial susceptibility testing of Gram-negative bacilli. VITEK 2 Gram Negative Trimethoprim/ sulfamethoxazole is a qualitative test 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. Trimethoprim/sulfamethoxazole has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial.
Active in vitro and in clinical infections
Escherichia coli (including susceptible enterotoxigenic strains implicated in traveler's diarrhea) Klebsiella species Proteus mirabilis Enterobacter species Shigella flexneri Morganella morganii Shigella sonnei Proteus vulgaris
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 the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, S. pneumoniae and clinically significant yeast.
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)
Luddei tu pocte
Division Sign Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K110166
p. 10