(95 days)
VITEK 2 AST-ST Ceftriaxone (K122359)
No
The description focuses on automated quantitative or qualitative susceptibility testing using miniaturized doubling dilution techniques and monitoring growth over time. There is no mention of AI or ML algorithms being used for interpretation or analysis.
No.
The device is described as a laboratory aid for antimicrobial susceptibility testing, which helps determine the effectiveness of antimicrobials on microorganisms; it does not directly treat or diagnose a disease.
Yes
The device is described as a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents" and is used for "automated quantitative or qualitative susceptibility testing of isolated colonies," which directly aligns with the definition of a diagnostic device by providing information for the diagnosis or treatment of disease.
No
The device description clearly outlines physical components (VITEK® 2 AST Cards, saline, incubator/reader) and a process involving rehydrating antimicrobial medium within a card, filling, sealing, and incubation. This indicates a hardware component is integral to the device's function.
Based on the provided text, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "antimicrobial susceptibility testing of Streptococcus species" and is a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents." The term "in vitro" is a key indicator of an IVD.
- Device Description: The description details a test performed on isolated colonies (biological samples) using a miniaturized microdilution methodology. This is a typical process for in vitro diagnostic testing.
- Performance Studies: The performance studies compare the device's results to a "CLSI broth microdilution reference method," which is a standard method for in vitro susceptibility testing.
- Predicate Device: The listed predicate device (VITEK 2 AST-ST Ceftriaxone) is also an AST card, which are generally classified as IVDs.
The device is designed to analyze biological samples (isolated bacterial colonies) outside of the body to provide information about their susceptibility to antimicrobial agents, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
VITEK 2 Streptococcus Meropenem 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 Meropenem is a quantitative test. Meropenem 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 strains) Streptococcus agalactiae Streptococcus pyogenes
The VITEK® 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
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
Not Found
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 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 Meropenem 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.
Summary of Performance Studies
The Premarket Notification (510(k)) presents data in support of VITEK® 2 AST-ST Meropenem. 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 Meropenem 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 Meropenem demonstrated acceptable performance of 98.6% overall essential Agreement and 96.6% overall category agreement with the reference method. Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics
98.6% overall essential Agreement and 96.6% overall category agreement.
Predicate Device(s)
VITEK 2 AST-ST Ceftriaxone (K122359)
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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Image /page/0/Picture/1 description: The image shows a logo with the text "BIOMERIEUX" written in a stylized font. Above the text is a circular symbol divided into two halves, with the left half shaded with vertical lines and the right half solid black. A thin, curved line extends vertically through the center of the circle, adding a dynamic element to the logo.
510(k) SUMMARY
Address:
VITEK® 2 AST-ST Meropenem
510(k) Submission Information:
Submitter's Name:
bioMérieux, Inc.
595 Anglum Road Hazelwood, MO 63042
Nathan Hardesty
Staff Regulatory Affairs Specialist
VITEK® 2 AST-ST Meropenem
VITEK® 2 AST-ST Meropenem
Contact Person:
Phone Number:
Fax Number:
314 -731-8666 314-731-8689
August 9, 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
NOV 1 5 2013
Common Name:
C. Predicate Device:
VITEK 2 AST-ST Ceftriaxone (K122359)
D. 510(k) Summary:
VITEK® 2 Streptococcus Meropenem is designed for antimicrobial susceptibility testing of Streptoccus 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 Meropenem is a quantitative test. Meropenem 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 strains) Streptococcus agalactiae Streptococcus pyogenes
The VITEK® 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, Staphylococus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast.
bioMérieux, Inc.
595 Anglum Road, Hazelwood, Missouri 63042-2320, USA Phone: 314/731-8500 800/638-4835 Fax: 314/731-8700 http://www.biomerieux-usa.com
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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.
VITEK® 2 AST-ST Meropeners 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 Meropenem. 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 Meropenem 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 Meropenem demonstrated acceptable performance of 98.6% overall essential Agreement and 96.6% overall category agreement with the reference method. Reproducibility and Quality Control demonstrated acceptable results.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized emblem that resembles an abstract caduceus or a symbol of health and medicine. The emblem consists of three curved lines that converge at the bottom, creating a sense of movement or flow.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Comrol Center - WO66-G609 Silver Spring, MD 20993-0002
November 15, 2013
bioMerieux, Inc. c/o Mr. Nathan Hardesty Staff Regulatory Affairs Specialist 595 Anglum Road Hazelwood, MO 63042
Re: K132507
Trade/Device Name: VITEK® 2 AST-ST Meropenem (4ug/mL) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Regulatory Class: II Product Code: LON Dated: August 27, 2013 Received: August 28, 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
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Page 2 - Mr. Hardesty
CFR Part 807); labeling (21 CFR Part 801); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Sally AFB/Wat -S
Sally A. Hojvat, M.Sc., Ph.D. 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): K132507
Device Name: VITEK® 2 AST-ST Meropenem ( ≤ 0.06 - ≥ 4 µg/mL )
Indications For Use:
VITEK 2 Streptococcus Meropenem 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 Meropenem is a quantitative test. Meropenem 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 strains) Streptococcus agalactiae Streptococcus pyogenes
The VITEK® 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 Center for Devices and Radiological Health (CDRH)
Ribhi Shawar -S 2013.11.12 16:59:21 -05'00'