(238 days)
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No
The description focuses on a miniaturized dilution technique and automated monitoring of microbial growth, with no mention of AI or ML algorithms for analysis or interpretation.
No
This device is a laboratory aid for determining the in vitro susceptibility of Streptococcus species to antimicrobial agents, not a device used to provide therapy to a patient.
Yes
The device is described as a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents" and is used for "antimicrobial susceptibility testing," which is a diagnostic process to determine the effectiveness of antibiotics against specific microorganisms.
No
The device description explicitly details hardware components (VITEK® 2 AST cards, VITEK® 2 and VITEK® 2 Compact Systems) and their physical processes (filling, sealing, incubation, monitoring growth). While software is involved in generating the report, the core functionality relies on physical hardware and biological processes.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents." "In vitro" means "in glass" or "in the lab," referring to tests performed outside of a living organism.
- Device Description: The description details how the device tests isolated colonies of microorganisms in a laboratory setting using a miniaturized microdilution methodology.
- Performance Studies: The performance studies compare the device's results to a "CLSI broth microdilution reference method," which is a standard laboratory technique for determining antimicrobial susceptibility.
- Intended User: The intended user is a "laboratory aid," further indicating its use in a clinical laboratory setting.
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens from the human body to provide information for diagnosis, treatment, or prevention of disease. In this case, the device is testing the susceptibility of bacteria to antibiotics, which is crucial information for guiding treatment decisions.
N/A
Intended Use / Indications for Use
VITEK® 2 Streptococcus Tetracycline is designed for antimicrobial susceptibility testing of Streptococcus species. VITEK 2 Streptococcus Tetracycline is a quantitative 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. Tetracycline has an antimicrobial activity against the microorganisms listed below, according to the FDA label for this antimicrobial.
Active in vitro and in clinical infections Streptococcus pneumoniae Streptococcus pyogenes Viridans group streptococci
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 spp. and clinically significant yeast.
Product codes
LON
Device Description
The VITEK® 2 AST cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.
The isolate to be tested is diluted to a standardized concentration with 0.45% to 0.50% 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 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 36 hours for yeast). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
laboratory aid
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 isolates, as well as a set of challenge strains. The external evaluations were designed to confirm the acceptability of VITEK® 2 Streptococus Tetracycline by comparing its performance with the CLSI broth microditution 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 Streptococcus Tetracycline 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 August 28, 2009.
VITEK® Streptococcus Tetracycline demonstrated acceptable performance of 96.8% overall essential agreement and 97.1% overall category agreement with the reference method. 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.)
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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.
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.
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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).
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§ 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
K///893
Image /page/0/Picture/1 description: The image shows the logo for bioMerieux. The logo consists of a circle split in half, with one half filled with horizontal lines and the other half solid black. A curved line runs vertically through the center of the circle. The text "BIOMERIEUX" is written in a stylized font below the circle.
FEB 2 8 2012
510(k) SUMMARY
VITEK® 2 Streptococcus Tetracycline
510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Jolyn Tenllado |
| Director, Regulatory Affairs | |
| Phone Number: | 314-731-8386 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | July 1st, 2011 |
B. Device Name:
| Formal/Trade Name: | VITEK® 2 Streptococcus Tetracycline |
|---|---|
| Classification Name: | 21 CFR 866.1645 |
| Antimicrobial Susceptibility Test | |
| Product Code LON | |
| Common Name: | VITEK® 2 AST-ST Tetracycline |
| Predicate Device: | VITEK® 2 AST-GP Amoxicillin for S. pneumoniae (K063597) |
D. 510(k) Summary:
C.
VITEK® 2 Streptococcus Tetracycline is designed for antimicrobial susceptibility testing of Streptococcus species. VITEK® 2 Streptococcus Tetracycline is a quantitative 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. Tetracvcline has an antimicrobial activity aqainst the microorganisms listed below, according to the FDA label for this antimicrobial.
Active in vitro and in clinical infections Streptococcus pneumoniae Streptococcus pyogenes Viridans group streptococci
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 susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast.
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
1
2
versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.
The isolate to be tested is diluted to a standardized concentration with 0.45% to 0.50% 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 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 36 hours for yeast). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card.
VITEK® 2 Streptococcus Tetracycline 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 August 28, 2009.
The Premarket Notification (510/k)) presents data in support of VITEK® 2 Streptococcus Tetracycline. An external evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to confirm the acceptability of VITEK® 2 Streptococus Tetracycline by comparing its performance with the CLSI broth microditution reference method. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms. VITEK® Streptococcus Tetracycline demonstrated acceptable performance of 96.8% overall essential agreement and 97.1% overall category agreement with the reference method. Reproducibility and Quality Control demonstrated acceptable results using both the VITEK® 2 and VITEK® 2 Compact instrument systems.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure, with flowing lines suggesting movement or energy.
10903 New Hampshire Avenue Silver Spring, MD 20993
bioMérieux, Inc. c/o Jolyn Tenllado Director, Regulatory Affairs 595 Anglum Road Hazelwood. MO 63042
FEB 2 8 2012
Re: K111893
Trade Name: VITEK®2 Streptococcus Tetracycline Regulation Number: 21 CFR §866.1645 Antimicrobial Susceptibility Test Regulation Name: Class II Regulatory Class: Product Code: LON Dated: February 10, 2012 Received: February 13, 2012
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 the Code of Federal Regulations. Title 21, Parts 800 to 898. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section
3
Page 2 - Jolyn Tenllado
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 Part 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,
Luedali tur Poole
for
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): KJLL833
Device Name; VITEK® 2 Streptococcus Tetracycline (≤ 0.25 - ≥ 16 ug/mL)
Indications For Use:
VITEK® 2 Streptococcus Tetracycline is designed for antimicrobial susceptibility testing of Streptococcus species. VITEK 2 Streptococcus Tetracycline is a quantitative 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. Tetracycline has an antimicrobial activity against the microorganisms listed below, according to the FDA label for this antimicrobial.
Active in vitro and in clinical infections Streptococcus pneumoniae Streptococcus pyogenes Viridans group streptococci
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 spp. 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)
Freddie W. Poole
Vision Sign-Off
Office of In Vitro Diagnostic Device . Evaluation and Safety
510(k) K111893
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