(115 days)
No
The description focuses on automated microdilution techniques and growth monitoring, with no mention of AI or ML algorithms for analysis or interpretation.
No.
This device is designed for in vitro diagnostic testing to determine antimicrobial susceptibility, not for direct therapeutic use on a patient.
Yes
Explanation: The device is described as "designed for antimicrobial susceptibility testing of Streptococcus species" and is intended for use "as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents," which directly relates to diagnosing conditions or determining appropriate treatment.
No
The device description explicitly details physical components like "AST Cards," "saline," and the "VITEK® 2 and VITEK® 2 Compact Systems" which are instruments that fill, seal, incubate, and read the cards. 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 Streptococcus species" 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." This clearly indicates it is used to test samples in vitro (outside the body) to provide information about a patient's condition (susceptibility to antibiotics).
- Device Description: The description details a method for testing bacterial isolates in a laboratory setting using a miniaturized microdilution technique. This is a standard method for in vitro diagnostic testing.
- Performance Studies: The performance studies describe testing clinical isolates and comparing the results to a reference method (CLSI broth microdilution), which is typical for validating an IVD.
- Intended User / Care Setting: The intended user is a "laboratory aid," further reinforcing its use in a clinical laboratory setting for diagnostic purposes.
The core function of the device is to perform a test on a biological sample (bacterial isolate) in vitro to provide information relevant to patient care (determining antibiotic susceptibility). This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VITEK 2 Streptococcus Tigecycline is designed for antimicrobial susceptibility testing of Streptococcus species 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 Streptococcus Tigecycline is a qualitative test. Tigecycline 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 Streptococcus pneumoniae (penicillin-susceptible isolates) Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus) Streptococcus agalactiae Streptococcus pyogenes
The VITER 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 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 spp. and clinically significant yeast.
Product codes
LON
Device Description
VITEK® 2 AST-ST Tigecycline is designed for antimicrobial susceptibility testing of Streptococcus species. The antimicrobial presented in VITEK® 2 AST-ST 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 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 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 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
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
An external evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge strains.
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
VITEK® 2 AST-ST Tigecycline 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 external evaluations were designed to confirm the acceptability of VITEK® 2 AST-ST Tigecycline by comparing its performance with the CLSI broth microdilution reference method incubated at 20 - 24 hrs. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms.
Key Metrics
99.8% overall category agreement with the reference method. Reproducibility and Quality Control demonstrated acceptable results.
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.”
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OCT 1 0 2013
Image /page/0/Picture/1 description: The image shows the logo for bioMerieux. The logo consists of a stylized circle divided into two halves, with the left half filled with horizontal lines and the right half left blank. Below the circle is the word "BIOMERIEUX" in a sans-serif font. A curved line runs vertically through the circle and extends below the word.
510(k) SUMMARY
VITEK® 2 AST-ST Tigecycline
510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Nathan Hardesty |
| Staff Regulatory Affairs Specialist | |
| Phone Number: | 314 -731-8666 |
| Fax Number: | 314-731-8689 |
May 31, 2013
B. Device Name:
Formal/Trade Name:
Date of Preparation:
Classification Name:
21 CFR 866.1645 Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Product Code LON
Common Name:
- C. Predicate Device:
VITEK 2 AST-ST Linezolid (K111599)
VITEK® 2 AST-ST Tigecycline
VITEK® 2 AST-ST Tigecycline
D. 510(k) Summary:
VITEK® 2 Streptococcus Tigecycline is designed for antimicrobial susceptibility testing of Streptococcus species 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 Streptococcus Tigecycline is a qualitative test. Tigecycline 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 Streptococcus pneumoniae (penicillin-susceptible isolates) Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus) Streptococcus agalactiae Streptococcus pyogenes
The antimicrobial presented in VITEK® 2 AST-ST 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.
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The 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 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 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 AST-ST Tigecvoline 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 AST-ST Tigecycline. 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 AST-ST Tigecycline by comparing its performance with the CLSI broth microdilution reference method incubated at 20 - 24 hrs. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms. VITEK 2 AST-ST Tigecycline demonstrated acceptable performance of 99.8% overall category agreement with the reference method. Reproducibility and Quality Control demonstrated acceptable results.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hompshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
BIOMERIEUX, INC. MR. NATHAN HARDESTY 595 ANGLUM RD. HAZELWOOD MO 63042
October 10, 2013
Re: K131779
Trade/Device Name: VITEK 2 AST-ST Tigecycline Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Regulatory Class: II Product Code: LON Dated: October 04, 2013 Received: October 08, 2013
Dear Mr. Hardesty:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 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.
Image /page/2/Picture/11 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the edge. In the center of the circle is a stylized image of an eagle or other bird with its wings spread. The logo is black and white.
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Page 2-Mr. Hardesty
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Sally A[unclear]ivat -S
Sally A. Hojvat Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):_________K131779
Device Name: VITEK® 2 AST-ST Tigecycline ( ≤ 0.06 -> 1 µg/mL )
Indications For Use:
VITEK 2 Streptococcus Tigecycline is designed for antimicrobial susceptibility testing of Streptococcus species 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 Streptococcus Tigecycline is a qualitative test. Tigecycline 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 Streptococcus pneumoniae (penicillin-susceptible isolates) Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus) Streptococcus agalactiae Streptococcus pyogenes
The VITER 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 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 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 Diagnostics and Radiological Health (OIR)
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