(25 days)
Not Found
No
The description focuses on automated quantitative or qualitative susceptibility testing based on growth monitoring and comparison to a reference method, with no mention of AI or ML algorithms.
No
This device is for in vitro susceptibility testing and laboratory aid, not for direct treatment of patients.
Yes
The device is designed for antimicrobial susceptibility testing of Streptococcus species and provides a quantitative test intended for determining in vitro susceptibility to antimicrobial agents, which aids in diagnosis and treatment decisions.
No
The device description clearly outlines physical components (AST cards, saline, incubator/reader) and automated/manual processes involving these components, indicating it is a hardware-based system with software control, not a software-only device.
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 device description details a method for testing the susceptibility of isolated colonies of microorganisms to antimicrobial agents in a laboratory setting using a miniaturized microdilution technique.
- Performance Studies: The performance studies compare the device's performance to a "CLSI broth microdilution reference method," which is a standard laboratory technique for determining antimicrobial susceptibility.
- Predicate Device: The predicate device listed (K063597; VITEK® 2 AST-GP Amoxicillin for S. pneumoniae) is also an IVD for antimicrobial susceptibility testing.
All of these points align with the definition and characteristics 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 microorganisms isolated from patients to help guide treatment decisions.
N/A
Intended Use / Indications for Use
VITEK® 2 Streptococcus Ceftriaxone is designed for antimicrobial susceptibility testing of Streptococcus species. VITEK® 2 Streptococcus Ceftriaxone 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.
Ceftriaxone has been shown to be active against most strains of the following microorganism, according to the FDA label for this antimicrobial.
Active In Vitro and in Clinical Infections against:
Streptococcus pneumoniae Streptococcus pyogenes Streptoccocus agalactiae 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 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 Streptococcus Ceftriaxone is designed for antimicrobial susceptibility testing of Streptococcus species. VITEK 2 Streptococcus Ceftriaxone 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.
Ceftriaxone has been shown to be active against most strains of the following microorganism, according to the FDA label for this antimicrobial.
Active In Vitro and in Clinical Infections against:
Streptococcus pneumoniae Streptococcus pyogenes Streptoccocus agalactiae 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 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.
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 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 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. The external evaluations were designed to confirm the acceptability of VITEK® 2 Streptococcus Ceftriaxone 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.
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)
VITEK® 2 Streptococcus Ceftriaxone 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 Ceftriaxone. 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 Streptococcus Ceftriaxone 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 Streptococcus Ceftriaxone demonstrated acceptable performance of 98.9% overall essential agreement and 97.2% 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.)
98.9% overall essential agreement and 97.2% overall category agreement
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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Image /page/0/Picture/1 description: The image shows the logo for bioMerieux. The logo consists of the company name in block letters, with a stylized graphic above it. The graphic is a circle split in half, with one half filled with horizontal lines and the other half solid black, and a curved line running through the center.
AUG 28 2012
510(k) SUMMARY
VITEK® 2 Streptococcus Ceftriaxone
510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Thi My Lan Dang |
| Regulatory Affairs Officer | |
| Phone Number: | 314-731-8799 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | June 12th, 2012 |
B. Device Name:
Formal/Trade Name:
Classification Name:
21 CFR 866.1645
VITEK® 2 Streptococcus Ceftriaxone
VITEK® 2 AST-ST Ceftriaxone (CRO)
Antimicrobial Susceptibility Test Product Code LON
Common Name:
C. Predicate Device:
VITEK® 2 AST-GP Amoxicillin for S. pneumoniae (K063597)
D. 510(k) Summary:
VITEK® 2 Streptococcus Ceftriaxone is designed for antimicrobial susceptibility testing of Streptococcus species. VITEK 2 Streptococcus Ceftriaxone 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.
Ceftriaxone has been shown to be active against most strains of the following microorganism, according to the FDA label for this antimicrobial.
Active In Vitro and in Clinical Infections against:
Streptococcus pneumoniae Streptococcus pyogenes Streptoccocus agalactiae 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 or qualitative susceptibility testing of
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 Page 239
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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 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 veast). At the completion 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 Ceftriaxone 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 Ceftriaxone. 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 Streptococcus Ceftriaxone 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 Streptococcus Ceftriaxone demonstrated acceptable performance of 98.9% overall essential agreement and 97.2% 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 stylized eagle with three stripes forming its wing and body. The eagle faces left and is positioned to the right of the text. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
bioMerieux, Inc. c/o Thi My Lan Dang Regulatory Affairs Officer 595 Anglum Road Hazelwood, Missouri 63042
AUG 28 2012
K122359 Re:
Trade Name: VITEK® 2 AST Streptococcus Ceftriaxone Regulation Number: 21 CFR §866.1645 Regulation Name: Fully automated short-term incubation cycle antimicrobial susceptibility system Regulatory Class: Class II
Product Codes: LON Dated: August 1, 2012 Received: August 3, 2012
Dear Ms. Dang:
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 either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 wa )) vice 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. or mo ret of any 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).
3
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Soyayya
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
K122359 510(k) Number (if known):
Device Name: VITEK® 2 Streptococcus Ceftriaxone (≤ 0.125 - ≥ 8 µg/mL)
Indications For Use:
VITEK® 2 Streptococcus Ceftriaxone is designed for antimicrobial susceptibility testing of Streptococcus species. VITEK® 2 Streptococcus Ceftriaxone 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.
Ceftriaxone has been shown to be active against most strains of the following microorganism, according to the FDA label for this antimicrobial.
Active In Vitro and in Clinical Infections against:
Streptococcus pneumoniae Streptococcus pyogenes Streptoccocus agalactiae 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)
Ludolie te Poole
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K122359
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