(258 days)
Not Found
No
The description focuses on a miniaturized doubling dilution technique and automated monitoring of bacterial growth, 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, providing a "laboratory aid" in determining drug effectiveness. It does not directly provide therapy or treatment to a patient.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is "designed for antimicrobial susceptibility testing of Gram-negative bacilli" and is a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents." This directly indicates its use in diagnosing the susceptibility of bacteria to certain drugs, which is a diagnostic function.
No
The device description clearly outlines physical components (AST Cards, VITEK® 2 and VITEK® 2 Compact Systems) and processes involving hardware (filling, sealing, incubation, reading). It is not solely software.
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." This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The device description details how it tests isolated colonies (specimens) in a laboratory setting to determine their susceptibility to antimicrobial agents. This process is performed outside of the living organism ("in vitro").
- Performance Studies: The performance studies compare the device's results to a reference method for determining antimicrobial susceptibility, further confirming its role in laboratory testing for diagnostic information.
- Predicate Device: The mention of a predicate device (VITEK®2 AST-GN Doxycycline) with a K number (K121546) indicates that this device has gone through the FDA's regulatory process for medical devices, which includes IVDs.
Therefore, based on the provided information, the VITEK® 2 Gram Negative Ceftriaxone device is clearly an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
VITEK® 2 Gram Negative Ceftriaxone is designed for antimicrobial susceptibility testing of Gram-negative bacilli. VITEK® 2 Gram Negative 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 microorganisms listed below, according to the FDA label for this antimicrobial.
Active in vitro and clinical infections:
Escherichia coli
Enterobacter aerogenes
Klebsiella pneumoniae
Proteus mirabilis
Klebsiella oxytoca
Serratia marcescens
In vitro data available but clinical significance is unknown:
Citrobacter freundii
Citrobacter koseri (formerly Citrobacter diversus)
Providencia species (including Providencia rettgeri)
Shigella species
Salmonella species (including Salmonella typhi)
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., S. pneumoniae, and clinically significant yeast.
Product codes
LON
Device Description
The antimicrobial presented in VITEK® 2 AST-GN 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
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-GN Ceftriaxone by comparing its performance with the CLSI broth microdilution reference method incubated at 16 - 20 hrs. 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 AST-GN 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. An external evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge strains. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms. VITEK® 2 AST-GN Ceftriaxone demonstrated acceptable performance of 97.5% overall Essential Agreement and 99.0% overall Category Agreement with the reference method. A performance limitation will be taken for Proteus vulgaris. Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
97.5% overall Essential Agreement
99.0% 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.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of three human profiles facing to the right, arranged in a stacked formation. The profiles are rendered in a dark color, creating a sense of depth and unity. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 12, 2017
BIOMERIEUX, INC. KAREN RUSSELL STAFF REGULATORY AFFAIRS SPECIALIST 595 ANGLUM ROAD HAZELWOOD MO 63042
Re: K161217
Trade/Device Name: VITEK 2 Gram Negative Ceftriaxone (64 u/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: December 22, 2016 Received: December 23, 2016
Dear Ms. Russell:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Ribhi Shawar -A
For Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
| Food and Drug Administration | |
|---|---|
| Indications for Use | VITEK® 2 AST-GN Ceftriaxone |
| Traditional 510(k) Submission | |
| K161217.AINN |
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below. |
| 510(k) Number (if known) | K161217 |
| Device Name | VITEK® 2 Gram Negative Ceftriaxone
(≤0.25-≥64 µg/mL) |
| Indications for Use (Describe) | VITEK® 2 Gram Negative Ceftriaxone is designed for antimicrobial susceptibility testing of Gram-negative bacilli.
VITEK® 2 Gram Negative 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 microorganisms listed below, according to the FDA label for this antimicrobial. |
| Active in vitro and clinical infections: | |
| | Escherichia coli |
| | Enterobacter aerogenes |
| | Klebsiella pneumoniae |
| | Proteus mirabilis |
| | Klebsiella oxytoca |
| | Serratia marcescens |
| In vitro data available but clinical significance is unknown: | |
| | Citrobacter freundii |
| | Citrobacter koseri (formerly Citrobacter diversus) |
| | Providencia species (including Providencia rettgeri) |
| | Shigella species |
| | Salmonella species (including Salmonella typhi) |
| | 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., S. pneumoniae, and clinically
significant yeast. |
| Type of Use (Select one or both, as applicable) | |
| | Prescription Use (Part 21 CFR 801 Subpart D) |
| | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
ස
这
ုး ၂၀၂ ခုစုများ ၂၀၇ ဦး၊ လူဦးရေ
3
VITEK® 2 AST-GN Ceftriaxone: Section 028. 510(k) Summary
A. 510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Karen Russell |
| Staff Regulatory Affairs Specialist | |
| Phone Number: | 314-731-8639 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | December 2, 2016 |
B. Device Name:
| Formal/Trade Name: | VITEK® 2 Gram Negative Ceftriaxone
(≤0.25 – ≥64 µg/mL) |
|----------------------|-------------------------------------------------------------------------------------------------------|
| Classification Name: | 21 CFR 866.1645
Fully Automated Short-Term Incubation Cycle
Antimicrobial Susceptibility System |
| Product Code | LON |
| Common Name: | VITEK® 2 AST-GN Ceftriaxone |
C. Predicate Device: VITEK®2 AST-GN Doxycycline (K121546)
D. 510(k) Summary:
VITEK® 2 Gram Negative Ceftriaxone is designed for antimicrobial susceptibility testing of Gram-negative bacilli. VITEK® 2 Gram Negative 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 microorganisms listed below, according to the FDA label for this antimicrobial.
Active in vitro and clinical infections: Enterobacter aerogenes Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis
4
Serratia marcescens
In vitro data available but clinical significance is unknown: Citrobacter koseri (formerly Citrobacter diversus) Citrobacter freundii Shigella species Providencia species (including Providencia rettgeri) Salmonella species (including Salmonella typhi)
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., S. pneumoniae, and clinically significant yeast.
The antimicrobial presented in VITEK® 2 AST-GN 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-GN 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 AST-GN 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 AST-GN Ceftriaxone by comparing its performance with the CLSI broth microdilution reference method incubated at 16 - 20 hrs. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms. VITEK® 2 AST-GN Ceftriaxone demonstrated acceptable performance of 97.5% overall Essential Agreement and 99.0% overall Category Agreement with the reference method. A performance limitation will be taken for Proteus vulgaris. Reproducibility and Quality Control demonstrated acceptable results.